Professional Documents
Culture Documents
).
Methods of
administration
Oral.
IM, IV bolus, IV infusion in NS, D5W. Volume for infusion depends on dose.
Side effects Immediate Short-term Long-term
Very common None selected* None selected* None selected*
Common None selected* None selected* None selected*
Uncommon None selected* Fever None selected*
Rare None selected* Life-threatening diarrhoea
when used in combination
with 5-fluorouracil 12
None selected*
Very rare Hypersensitivity/
anaphylaxis 52
None selected* None selected*
Unknown None selected* None selected* None selected*
Nursing implications ( 1
2
3
etc) see pages 20-29. *None selected for the purposes of this handbook
G
Guide to frequency of side effects
Very common (1/10)
Common (1/100 to <1/10)
Uncommon (1/1000 to <1/100)
Rare (1/10,000 to <1/1,000)
Very rare (<1/10,000)
Unknown (cannot be estimated from the available data spontaneous reports)
Some (but not all) of the adverse events experienced with the drugs over time are listed
in the monographs. Please consult individual SPCs for full details.
Lilly Handbook of Systemic Treatments for Cancer 8th Edition
85
GEFITINIB
Generic name Gefitinib
Trade name Iressa
Drug action EGFR tyrosine kinase inhibitor.
Specific
information
Gefitinib is metabolised in the liver by cytochrome P450 enzymes. Drugs that are
inhibitors or inducers of these enzymes may interact with gefitinib.
Drugs that cause significant sustained elevation in gastric pH, such as PPIs and
H
2
-antagonists, may reduce plasma concentrations of gefitinib.
Methods of
administration
Oral. Tablets should be taken with or without food.
For patients with swallowing difficulties, the tablet may be dropped in half a glass of
non-carbonated water and swirled occasionally until dispersed (this may take up to
20 mins), then drunk immediately. The glass should be rinsed with half a glass of
water, which should also be drunk. The dispersion can also be administered through
a feeding tube.
Side effects Immediate Short-term Long-term
Very common None selected*
Nausea and vomiting 10,
diarrhoea 12, anorexia 8 ,
stomatitis 6 , asthenia, skin
reactions (mild to
moderate) 19
Abnormal LFTs 24
Common
Fever 5 Conjunctivitis 38,
blepharitis 38, dry eye 38,
haemorrhage, dry mouth,
nail disorders, proteinuria,
cystitis
Increased creatinine,
alopecia 23, ILD 26
Uncommon
Hypersensitivity 52 Keratitis/corneal ulcer,
pancreatitis, GI perforation
Hepatitis 24
Rare None selected* Stevens-Johnson
syndrome/TEN 22, erythema
multiforme 22,
haemorrhagic cystitis 29,
cutaneous vasculitis
None selected*
Very rare None selected* None selected* None selected*
Unknown None selected* None selected* None selected*
Nursing implications ( 1
2
3
etc) see pages 20-29. *None selected for the purposes of this handbook
February 2014
86
GEMCITABINE
Generic name Gemcitabine
Trade name Gemzar
Drug action Antimetabolite.
Specific
information
Radiosensitiser reduce dose if given with, or within 7 days of radiotherapy.
Methods of
administration
IV infusion over 30 mins in 100ml NS.
Side effects Immediate Short-term Long-term
Very common
Dyspnoea (mild) 26,
rash (mild) 19,
pruritus 21
Nausea and vomiting 10,
flu-like symptoms 51,
anorexia 8 , peripheral/
facial oedema
BMD (mild to
moderate) 1 2 3 , alopecia
(minimal) 23, abnormal
LFTs 24, proteinuria /
haematuria
Common None selected*
Diarrhoea 12,
constipation 11,
stomatitis 6 , headache 34,
insomnia, somnolence,
myalgia 34, back pain 34,
sweating, fever, asthenia,
chills, cough 26, rhinitis
None selected*
Uncommon Bronchospasm
(usually mild, but may
need parenteral
treatment)
None selected* CVA, arrhythmia, heart
failure 25, serious
hepatotoxicity 24, renal
failure 30, haemolytic
uraemic syndrome,
interstitial pneumonitis 26
Rare None selected* Peripheral vasculitis and
gangrene, pulmonary
oedema, ARDS, skin and
injection site reactions,
radiation sensitivity,
increased GGT
Radiation recall 55, MI 25,
hypotension 54
Very rare
Anaphylaxis 52 Ischaemic colitis Stevens-Johnson syndrome/
TEN 22, thrombocytosis,
capillary leak syndrome
Unknown None selected* None selected* None selected*
Nursing implications ( 1
2
3
etc) see pages 20-29. *None selected for the purposes of this handbook
H
Guide to frequency of side effects
Very common (1/10)
Common (1/100 to <1/10)
Uncommon (1/1000 to <1/100)
Rare (1/10,000 to <1/1,000)
Very rare (<1/10,000)
Unknown (cannot be estimated from the available data spontaneous reports)
Some (but not all) of the adverse events experienced with the drugs over time are listed
in the monographs. Please consult individual SPCs for full details.
Lilly Handbook of Systemic Treatments for Cancer 8th Edition
87
HYDROXYCARBAMIDE
Generic name Hydroxycarbamide, hydroxyurea
Trade name Hydrea
Drug action Antimetabolite.
Specific
information
Instruct patient to maintain high fluid intake.
Patients should be advised to report skin ulceration as it may necessitate
modification or cessation of therapy.
Skin cancer has been reported in patients receiving long-term hydroxycarbamide
therapy; patients should be advised to protect skin from sun exposure and conduct
self-inspection of the skin and be screened for secondary malignancy during routine
follow-up visits.
Megaloblastosis which does not respond to treatment with folic acid or vitamin B12
may occur.
High doses may cause drowsiness.
Methods of
administration
Oral. If the patient is unable to swallow capsules, contents may be emptied into a
glass of water and taken immediately. The contents of capsules should not be
inhaled or allowed to come into contact with the skin or mucous membranes.
Spillages must be wiped immediately.
Side effects Immediate Short-term Long-term
Very common None selected* None selected* None selected*
Common None selected*
Diarrhoea 12, constipation 11 BMD 1 2 3
Uncommon/
rare
(Exact
frequency is
unknown)
Rash 19, erythema,
fever, chills, malaise,
increased LFTs 24,
acute pulmonary
reactions (diffuse
infiltrates, fever,
dyspnoea) 26,
alopecia 23
Nausea and vomiting 10,
transient renal tubular
impairment, tumour lysis
syndrome 31,
hypersensitivity (including
allergic alveolititis) 52
Stomatitis 6 , anorexia 8 ,
dysuria, seizures and
hallucinations 33, skin ulcer
Very rare None selected* None selected*
Renal impairment 30,
dermatomyositis-like skin
changes, skin and nail
pigmentation 16, skin and
nail atrophy, pruritus 21,
actinic keratosis, skin
cancer, violet papules,
desquamation
Unknown None selected* None selected* Secondary leukaemia
Nursing implications ( 1
2
3
etc) see pages 20-29. *None selected for the purposes of this handbook
I
Guide to frequency of side effects
Very common (1/10)
Common (1/100 to <1/10)
Uncommon (1/1000 to <1/100)
Rare (1/10,000 to <1/1,000)
Very rare (<1/10,000)
Unknown (cannot be estimated from the available data spontaneous reports)
Some (but not all) of the adverse events experienced with the drugs over time are listed
in the monographs. Please consult individual SPCs for full details.
Lilly Handbook of Systemic Treatments for Cancer 8th Edition
89
IDARUBICIN
Generic name Idarubicin
Trade name Zavedos
Drug action Anthracycline antibiotic.
Specific
information
Cumulative dose limits for IV or oral idarubicin have not been defined. However,
idarubicin-related cardiomyopathy was reported in 5% of patients who received
cumulative IV doses of 150 to 290mg/m
2
. Available data on patients treated with oral
idarubicin total cumulative doses up to 400mg/m
2
suggest a low probability of
cardiotoxicity.
Cardiac function monitoring must be particularly strict in patients receiving high
cumulative doses and in those with risk factors (eg, previous anthracycline
exposure).
Methods of
administration
VESICANT AVOID EXTRAVASATION.
Oral. Capsules should be swallowed whole.
IV, slow administration over 5 to 10 mins via the tubing of a freely running IV infusion
of NS.
Side effects Immediate Short-term Long-term
Very common
Fever/chills 51 Nausea/vomiting (severe in
high doses) 10, mucositis,
stomatitis 6 , diarrhoea 12,
abdominal pain,
infections 5 , red urine (for
1-2 days) 28, headache 34
Anorexia 8
,
alopecia,
BMD (nadir 10-15
days) 1 2 3
Common None selected*
Phlebitis 17, haemorrhage
(including GI), rash, pruritus
Increased LFTs 24,
cardiotoxicity (arrhythmia,
decreased LVEF, CHF,
cardiomyopathy) 25,
radiation recall 55
Uncommon Dehydration, shock,
sepsis, oesophagitis,
colitis, ECG
abnormalities 25
MI, skin and nail
hyperpigmentation 15 16,
cellulitis (can be severe),
tissue necrosis,
hyperuricaemia 41,
secondary leukaemia
None selected*
Rare None selected* None selected* Cerebral haemorrhage
Very rare
Anaphylaxis 52, flush
None selected*
Pericarditis, myocarditis 25,
AV and BB block, gastric
erosions, thromboembolism,
PPE 20
Unknown Local reactions,
tumour lysis
syndrome 31
None selected* None selected*
Nursing implications ( 1
2
3
etc) see pages 20-29. *None selected for the purposes of this handbook
February 2014
90
IFOSFAMIDE
Generic name Ifosfamide
Trade name N/A
Drug action Alkylating agent (analogue of cyclophosphamide).
Specific
information
Nephrotoxic patient should be well hydrated. Ifosfamide should not be used
without the concurrent administration of mesna to protect against urothelial
damage and resultant haemorrhagic cystitis. Urine should be sent for laboratory
analysis before and at the end of each course of treatment, and the patient should
be monitored for output and evidence of proteinuria and haematuria at regular
intervals throughout treatment period.
Ifosfamide is neurotoxic and can occasionally result in encephalopathy (usually in
the first 3 days after infusion). Signs of CNS toxicity (confusion, dizziness,
somnolence etc) should be reported early to the patients medical team for
investigation.
Methods of
administration
IV infusion, for use as a dilute solution only, usually in 500-1000ml NS (infusion time
is regimen-dependent).
Mesna can be added directly to the infusion bag of ifosfamide during aseptic
preparation.
Side effects Immediate Short-term Long-term
Very common None selected* Nausea and vomiting (often
severe with high doses) 10,
alopecia 23
BMD 1 2 3 , alopecia 23,
nephrotoxicity, dysuria 30,
haemorrhagic cystitis 29
Common
Thrombophlebitis 17 Anorexia 8 , stomatitis 6 ,
CNS effects (including,
lethargy, disorientation,
confusion) 33, agitation,
depressive psychoses,
hallucinations, dermatitis,
impaired gonadal
function 27,
hypersensitivity 52,
polyneuropathy,
pneumonitis, visual
impairment 38, radiation
sensitivity 55
Rash 19
Uncommon None selected*
Hepatic impairment 24,
SIADH
None selected*
Rare None selected* Seizures, tonic-clonic
spasm, motor unrest,
emotional lability, severe
encephalopathy 33, acute
pancreatitis, arrhythmia,
heart failure (very high
doses) 25
None selected*
Very rare None selected* None selected* None selected*
Unknown None selected* None selected* None selected*
Nursing implications ( 1
2
3
etc) see pages 20-29. *None selected for the purposes of this handbook
Lilly Handbook of Systemic Treatments for Cancer 8th Edition
91
IMATINIB
Generic name Imatinib
Trade name Glivec
Drug action Tyrosine kinase inhibitor.
Specific
information
Imatinib is metabolised in the liver by cytochrome P450 CYP3A4 enzymes. Drugs
that are inhibitors or inducers of these enzymes may interact with imatinib.
TSH levels should be monitored closely in thyroidectomy patients on levothyroxine.
Methods of
administration
Oral. For patients with swallowing difficulties, the tablets may be dispersed in
mineral water or apple juice (50ml for 100mg tablet, 200ml for 400mg tablet).
Side effects Immediate Short-term Long-term
Very common None selected*
Nausea and vomiting 10,
diarrhoea 12, dyspepsia 9 ,
abdominal pain, headache 34,
rash 19, fatigue 53
BMD 1 2 3 , oedema, skin
reactions, cramp,
musculoskeletal pain 34,
weight gain
Common None selected*
Anorexia 8 , dysgeusia 7 ,
insomnia, dizziness 33,
flushing, dyspnoea 26, chills,
rigors, fever, paraesthesia,
hypoaesthesia, flatulence,
abdominal distension, GORD,
constipation, dry mouth,
gastritis, haemorrhage
Eye disorders (including
conjunctivitis, glaucoma) 38,
epistaxis, cough, increased
LFTs 24, alopecia 23,
photosensitivity 37, night
sweats, joint swelling,
weight loss
Uncommon None selected* Electrolyte disturbances,
infections 5 , migraine,
stomatitis 6 , mucositis 6 ,
eructation, renal pain,
haematuria, acute renal
failure 30, increased urinary
frequency, chest pain,
dehydration
Lymphadenopathy,
thrombocythaemia,
hyperglycaemia 39, anxiety,
depression, somnolence,
syncope, memory impairment,
neuropathy, tremor, restless
legs, tinnitus 35, hearing
loss 35, cardiac disorders,
hypotension/hypertension 54,
Raynauds phenomenon,
gynaecomastia 47, irregular
periods, erectile dysfunction 27,
sciatica, pleural effusion,
ascites, gastric ulcer, cheilitis,
dysphagia, pancreatitis,
hyperuricaemia, 40 hepatitis,
jaundice 24
Rare None selected* Acute generalised
exanthematous pustulosis,
haemorrhagic ovarian cyst,
increased blood amylase
Increased intracranial
pressure, seizures 33, pleuritic
pain, pulmonary fibrosis 26,
IBD, colitis, ileus, tumour
lysis syndrome 31, confusion,
hepatic necrosis, Sweets
syndrome, nail
discolouration 15, angioedema,
Stevens-Johnson syndrome 22,
arthritis, rhabdomyolysis
Very rare None selected* None selected* None selected*
Unknown None selected* None selected* DRESS
Nursing implications ( 1
2
3
etc) see pages 20-29. *None selected for the purposes of this handbook
February 2014
92
INTERFERON ALFA
Generic name Interferon alfa
Trade name IntronA, Roferon-A
Drug action Not completely understood. Antiproliferative activity against tumour cells by
immunomodulatory mechanisms.
Specific
information
N/A
Methods of
administration
SC, IM, IV (IntronA solution for injection or infusion). For IV infusion, add dose to
50ml NS and infuse over 20 mins.
Side effects Immediate Short-term Long-term
Very common Injection site reactions
Anorexia 8 , GI disturbances
(including nausea 10,
diarrhoea 12),
hypocalcaemia 41, flu-like
symptoms 51, headache 34,
musculoskeletal pain 34,
fatigue 53, increased
sweating, dizziness,
dyspnoea 26, visual
impairment
BMD 1 2 3 , alopecia 23
Common None selected*
Dysgeusia 7 , cyanosis, dry
mouth, oedema,
conjunctivitis 38,
hypertension 54, tremor,
dehydration, somnolence,
psoriasis, hyperuricaemia 40,
epistaxis, rash 19
None selected*
Uncommon None selected* None selected* Psychiatric effects (including
depression and suicidal
ideation) 33, neuropathy 33,
increased LFTs
Rare Hypersensitivity/
anaphylaxis 52
Erectile dysfunction 27,
cardiac disorders (including
MI, CHF) 25, mucosal
dryness
Haemolytic anaemia,
autoimmune disorders, CVA,
seizures, renal
impairment 30, increased
LDH, ischaemic
retinopathy 38
Very rare None selected*
Hypotension 54 Pancreatitis, hepatotoxicity,
pneumonitis,
hyperglycaemia 39
Unknown None selected* None selected* None selected*
Nursing implications ( 1
2
3
etc) see pages 20-29. *None selected for the purposes of this handbook
Lilly Handbook of Systemic Treatments for Cancer 8th Edition
93
IPILIMUMAB
Generic name Ipilimumab
Trade name Yervoy
Drug action T-cell potentiator that results in T-cell activation, proliferation, and lymphocyte
infiltration into tumours, leading to tumour cell death.
Specific
information
Ipilimumab is associated with inflammatory adverse reactions resulting from
increased or excessive immune activity.
Methods of
administration
IV over 90 mins in 100ml NS. Use an infusion set and an in-line, sterile, non-
pyrogenic, low protein binding filter (pore size of 0.2-1.2 micron).
Side effects Immediate Short-term Long-term
Very common Injection site
reactions 14
Skin reactions 19 21,
GI disturbances
(eg, diarrhoea 12, nausea
and vomiting 10), anorexia,
fever
Fatigue 53
Common
Hot flushes 18 Tumour pain 48, dehydration,
hypokalaemia 44, confusion,
dizziness, headache 34,
lethargy, blurred vision, eye
pain 38, hypotension 54,
dyspnoea, cough 26, GORD,
abdominal pain 34, hepatic
impairment 24, alopecia 27,
night sweats, chills,
asthenia, oedema, pain
Anaemia 1 , lymphopenia,
hypopituitarism,
hypothyroidism 45,
peripheral neuropathy 32,
GI inflammation,
constipation 11,
GI haemorrhage,
musculoskeletal pain,
muscle spasm
Uncommon
Hypersensitivity 52 UTI, RTI,
thrombocytopenia 3 ,
eosinophilia, neutropenia,
amenorrhoea 27,
infusion-related reactions
14, hyponatraemia, alkalosis,
hypophosphataemia 42,
tumour lysis syndrome 31,
mental status changes,
foreign body sensation in
eyes, conjunctivitis 38,
arrhythmia
Sepsis, adrenal insufficiency,
hyperthyroidism 45,
hypogonadism, Guillain-
Barr syndrome, aseptic
meningitis, syncope, cranial
neuropathy, brain oedema,
ataxia, tremor, myoclonus,
dysarthria, multi-organ
failure, GI ulcer/perforation,
uveitis, vitreous
haemorrhage, peritonitis,
pancreatitis, oesophagitis,
ileus, atrial fibrillation 25,
angiopathy, respiratory
failure 26, ARDS, lung
infiltrates, pneumonitis 26,
hepatic failure, hepatitis,
hepatomegaly 24, TEN,
polymyalgia rheumatica,
arthritis, renal failure 30,
renal tubular acidosis
Rare None selected* None selected* None selected*
Very rare None selected* None selected* None selected*
Unknown None selected* None selected* None selected*
Nursing implications ( 1
2
3
etc) see pages 20-29. *None selected for the purposes of this handbook
February 2014
94
IRINOTECAN
Generic name Irinotecan
Trade name Campto
Drug action Topoisomerase I inhibitor.
Specific
information
IRRITANT.
Delayed diarrhoea may occur more than 24 hrs after administration and at any time
before the next cycle. This can be life-threatening, especially if the patient is
neutropenic. Fluid and electrolyte replacement must be instigated immediately.
High doses of loperamide must be used, and a prophylactic broad-spectrum
antibiotic should be given if neutropenia is confirmed or suspected. Hospitalisation
is recommended in the presence of fever, or if the diarrhoea persists beyond 48 hrs.
Since irinotecan is partly metabolised by cytochrome P450 CYP3A4, drugs that
inhibit or induce these enzymes may alter the pharmacokinetics of irinotecan and
co-administration should be avoided.
Methods of
administration
IV infusion over 30-90 mins in 250ml NS or D5W.
Side effects Immediate Short-term Long-term
Very common None selected*
Diarrhoea 12 BMD 1 2 3 , alopecia 23
Common Acute cholinergic
syndrome (diarrhoea,
abdominal pain,
conjunctivitis,
hypotension, chills,
malaise, dizziness,
miosis, increased
salivation); treat with
atropine
Nausea and vomiting 10 Increased LFTs 24,
constipation 11, transient
elevation of serum creatinine
Uncommon None selected*
Hypersensitivity 52 None selected*
Rare
Anaphylaxis 52,
hypertension 54
None selected* None selected*
Very rare None selected* None selected* Transient speech disorders
Unknown None selected* None selected*
ILD 26
Nursing implications ( 1
2
3
etc) see pages 20-29. *None selected for the purposes of this handbook
L
Guide to frequency of side effects
Very common (1/10)
Common (1/100 to <1/10)
Uncommon (1/1000 to <1/100)
Rare (1/10,000 to <1/1,000)
Very rare (<1/10,000)
Unknown (cannot be estimated from the available data spontaneous reports)
Some (but not all) of the adverse events experienced with the drugs over time are listed
in the monographs. Please consult individual SPCs for full details.
Lilly Handbook of Systemic Treatments for Cancer 8th Edition
95
LAPATINIB
Generic name Lapatinib
Trade name Tyverb
Drug action Dual tyrosine kinase inhibitor, inhibiting EGFR (ErbB1) and HER2 (ErbB2).
Specific
information
Cardiac function, including LVEF, should be evaluated prior to initiating lapatinib,
and be monitored throughout treatment. Treatment should be discontinued in
patients with symptoms of decreased LVEF equal to NCI CTCAE grade 3 or above, or
if LVEF drops below the institutions lower limit of normal.
Caution should be taken in patients with conditions that could result in QT
prolongation or if co-administered with other drugs that cause QT prolongation.
Hypokalaemia and hypomagnesaemia should be corrected prior to treatment.
Monitor for symptoms of pulmonary toxicity (dyspnoea, cough, fever) and
discontinue treatment if symptoms are NCI CTCAE grade 3 or greater.
May cause severe diarrhoea, requiring oral and/or IV electrolyte and fluid
replacement. Proactive management with antidiarrhoeals is recommended. Patients
should promptly report changes in bowel patterns. May require dose interruption,
reduction or discontinuation.
Predominantly metabolised by cytochrome P450 CYP3A and therefore interacts with
many drugs affecting these enzymes.
Avoid concomitant treatment with substances that increase gastric pH.
Methods of
administration
Oral, as a single daily dose, at least 1 hr before or 1 hr after food. Administration
time relative to food should be kept the same throughout treatment.
Avoid grapefruit juice.
Side effects Immediate Short-term Long-term
(Note: Many side effects reported when combined with capecitabine, trastuzumab or letrozole)
Very common None selected*
Hot flushes 18, headache,
diarrhoea 12, nausea and
vomiting 10, constipation,
abdominal pain,
dyspepsia 9 , stomatitis 6 ,
epistaxis, cough 26,
dyspnoea
Rash 19, dry skin,
pruritus 21, alopecia 23,
PPE 20, arthralgia, back
pain, pain in extremity 34,
fatigue 53, asthenia,
anorexia 8 , insomnia,
mucositis
Common None selected* None selected*
Decreased LVEF 24,
hyperbilirubinaemia,
hepatotoxicity, nail disorders
(including paronychia) 15,
ILD/pneumonitis 26
Uncommon None selected* None selected* None selected*
Rare Hypersensitivity/
anaphylaxis 52
None selected* None selected*
Very rare None selected* None selected* None selected*
Unknown None selected* None selected* None selected*
Nursing implications ( 1
2
3
etc) see pages 20-29. *None selected for the purposes of this handbook
February 2014
96
LENALIDOMIDE
Generic name Lenalidomide
Trade name Revlimid
Drug action Immunomodulator and angiogenesis inhibitor.
Specific
information
All patients treated must follow the conditions of the Pregnancy Prevention
Programme (except women meeting criteria of non-childbearing potential).
Close monitoring required in patients with cardiac and thromboembolic risk factors.
VTE prophylaxis may be necessary.
Treatment should be discontinued and not resumed in cases of exfoliative or bullous
rash or other suspected severe skin reactions.
Methods of
administration
Oral. The capsules should be swallowed whole, with water, with or without food.
Side effects Immediate Short-term Long-term
Very common None selected*
Nausea and vomiting 10,
diarrhoea 12,
constipation 11, flu-like
symptoms 51, infections
(including RTI) 5 ,
dyspnoea 26, epistaxis, rash,
dry skin, pruritus 19,
fatigue 53, oedema,
anorexia 8 ,
hypokalaemia 44, dizziness,
tremor, headache 34
BMD 1 2 3 , VTE, muscle
spasm, pain (bone, muscle
and connective tissue) 34,
blurred vision 38
Common None selected*
Sepsis 5 , abnormal LFTs 24,
hypotension/hypertension
54, dry mouth, stomatitis 6 ,
dyspepsia 9 ,
hyperglycaemia 39, iron
overload
Cataracts 38, deafness/
tinnitus 35,
hypothyroidism 45,
arrhythmia 25, haematuria,
renal failure 30, urinary
incontinence, GI ulcer and
haemorrhage,
hypomagnesaemia 42,
hypocalcaemia 41, chest
pain, lethargy, depression,
confusion, erectile
dysfunction 27,
hyperhidrosis, skin
hyperpigmentation 16, joint
swelling, ataxia
Uncommon None selected*
Hypersensitivity 52, colitis,
hepatic failure 24
Intracranial haemorrhage,
TIA, skin cancer,
photosensitivity 37,
haemolysis, loss of libido 27,
acquired Fanconi syndrome,
blindness
Rare None selected*
Tumour lysis syndrome 31 None selected*
Very rare None selected* None selected* None selected*
Unknown None selected* None selected* None selected*
Nursing implications ( 1
2
3
etc) see pages 20-29. *None selected for the purposes of this handbook
Lilly Handbook of Systemic Treatments for Cancer 8th Edition
97
LOMUSTINE
Generic name Lomustine
Trade name N/A
Drug action Alkylating agent; also inhibits nucleic acid synthesis and repair of single-strand
DNA breaks.
Specific
information
Baseline and frequent monitoring of pulmonary function recommended.
Crosses blood-brain barrier.
Methods of
administration
Oral. Capsules should be swallowed whole.
Side effects Immediate Short-term Long-term
Very common None selected*
Rash 19, dry skin,
diarrhoea 12, abnormal
LFTs 24
Thrombocytopenia (nadir
approx 4 weeks) 3 ,
leucopenia (nadir approx 5-6
weeks) 2 ; haematological
toxicity may be cumulative)
Common None selected* None selected* None selected*
Uncommon None selected* None selected*
Anaemia 1
Rare None selected* None selected*
Interstitial pneumonia 26,
lung fibrosis 26,
stomatitis 6 , diarrhoea 12,
alopecia 23
Very rare None selected* None selected* None selected*
Unknown Nausea and
vomiting 10
Anorexia 8 Renal impairment 30,
lung infiltrates 26, abnormal
coordination,
disorientation 33, confusion,
dysarthria, lethargy, visual
impairment 38
Nursing implications ( 1
2
3
etc) see pages 20-29. *None selected for the purposes of this handbook
M
Guide to frequency of side effects
Very common (1/10)
Common (1/100 to <1/10)
Uncommon (1/1000 to <1/100)
Rare (1/10,000 to <1/1,000)
Very rare (<1/10,000)
Unknown (cannot be estimated from the available data spontaneous reports)
Some (but not all) of the adverse events experienced with the drugs over time are listed
in the monographs. Please consult individual SPCs for full details.
Lilly Handbook of Systemic Treatments for Cancer 8th Edition
99
MELPHALAN
Generic name Melphalan
Trade name N/A
Drug action Alkylating agent.
Specific
information
N/A
Methods of
administration
Slow IV bolus, regional IA perfusion, IV infusion in NS only.
Oral.
Side effects Immediate Short-term Long-term
Very common None selected*
Nausea and vomiting 10 ,
diarrhoea 12
BMD (delayed onset
2-3 weeks) 1 2 3 ,
stomatitis 6 , alopecia 23
Common None selected* None selected* None selected*
Uncommon None selected* None selected* None selected*
Rare
Anaphylaxis 52 Hypersensitivity 52 Pulmonary fibrosis 26,
haemolytic anaemia, hepatic
disorders (abnormal LFTs,
hepatitis, jaundice) 24,
dermatitis 19
Very rare None selected* None selected* None selected*
Unknown None selected* None selected* None selected*
Nursing implications ( 1
2
3
etc) see pages 20-29. *None selected for the purposes of this handbook
February 2014
100
MERCAPTOPURINE
Generic name Mercaptopurine, 6MP
Trade name N/A
Drug action Antimetabolite.
Specific
information
Allopurinol increases mercaptopurine toxicity by inhibiting its metabolism.
Mercaptopurine dose should be lowered if given with allopurinol.
Methods of
administration
Oral.
Side effects Immediate Short-term Long-term
Very common None selected* None selected*
BMD (mild) 1 2 3
Common None selected* Mild nausea and vomiting
(with high doses) 10
Diarrhoea (with high
doses) 12, hepatotoxicity 24
Uncommon None selected* None selected* None selected*
Rare None selected* None selected* Stomatitis (with high
doses) 6 , alopecia 23,
intestinal ulcer
Very rare None selected* None selected* None selected*
Unknown None selected* None selected* None selected*
Nursing implications ( 1
2
3
etc) see pages 20-29. *None selected for the purposes of this handbook
Lilly Handbook of Systemic Treatments for Cancer 8th Edition
101
MESNA
Generic name Mesna
Trade name N/A
Drug action Prevents urothelial toxicity associated with ifosfamide or cyclophosphamide. Exerts
detoxifying effect in efferent urinary tract and bladder.
Specific
information
Increased incidence of pseudoallergic reactions observed in patients with
autoimmune disorders.
Mesna may cause false positive or false negative results in urine dipstick tests for
ketones or erythrocytes.
Methods of
administration
Oral, IV bolus, IV infusion in NS, DS or D5W.
Although mesna tablets are available, the injection formulation can also be taken
orally, added to flavoured drink. Ref: BNF.
Side effects Immediate Short-term Long-term
Very common None selected* None selected* None selected*
Common None selected* None selected* None selected*
Uncommon None selected* None selected* None selected*
Rare
Anaphylaxis 52 None selected* None selected*
Very rare None selected* None selected* None selected*
Unknown None selected*
Nausea and vomiting 10,
diarrhoea 12,
constipation 11, headache,
colic, rash, fatigue 53,
hypotension 54, tachycardia,
limb and joint pain,
depression, irritability
None selected*
Nursing implications ( 1
2
3
etc) see pages 20-29. *None selected for the purposes of this handbook
February 2014
102
METHOTREXATE
Generic name Methotrexate
Trade name Maxtrex (tablets)
Drug action Antimetabolite.
Specific
information
Doses over 100mg/m
2
should not be administered without folinic acid rescue or
assay of serum methotrexate levels 24-48 hrs after dosing.
Methotrexate is extensively protein bound; acidic drugs may increase the risk of
methotrexate toxicity see product literature.
Avoid concomitant use of penicillins, NSAIDs (enhance toxicity of methotrexate by
reducing tubular secretion of methotrexate) and folate antagonists eg, trimethoprim
(severe BMD).
Contraindicated in pre-existing blood dyscrasias, such as bone marrow hypoplasia,
leucopenia, thrombocytopenia or significant anaemia.
Methods of
administration
IV bolus, IV infusion, IM, IA, oral.
Intrathecal refer to national intrathecal guidance.
Diluent: D5W, NS.
Side effects Immediate Short-term Long-term
Very common None selected*
Nausea and vomiting 10,
abdominal pain,
stomatitis 6 , anorexia 8 ,
abnormal LFTs
None selected*
Common Diarrhoea Herpes zoster,
BMD 1 2 3 , headache 34,
fatigue 53, drowsiness,
exanthema, erythema,
pruritus 21
Pulmonary complications
due to interstitial
pneumonitis (typical
symptoms dry cough,
dyspnoea, chest pain and
fever; discontinue treatment
and exclude infection) 26
Uncommon None selected* Vertigo, confusion,
depression, seizures 33,
encephalopathy, GI
haemorrhage and ulcer,
pancreatitis
None selected*
Rare None selected* Pericarditis, pericardial
effusion, pericardial
tamponade 25, renal
impairment 30, oliguria,
anuria, visual impairment
Hypotension 54,
thromboembolism, diabetes
Very rare
Anaphylaxis 52 Sepsis 5 , opportunistic
infections 5 ,
lymphadenopathy,
lymphoproliferative
disorders, insomnia,
cognitive impairment, pain,
myasthenia, tumour lysis
syndrome 31
None selected*
Unknown None selected* None selected* None selected*
Nursing implications ( 1
2
3
etc) see pages 20-29. *None selected for the purposes of this handbook
Lilly Handbook of Systemic Treatments for Cancer 8th Edition
103
MIFAMURTIDE
Generic name Mifamurtide, muramyl tripeptide phosphatidyl ethanolamine (MTP-PE)
Trade name Mepact
Drug action Immunomodulator.
Specific
information
The administration times of mifamurtide and doxorubicin or other lipophilic
medicinal products should be separated.
Mifamurtide acts through stimulation of the immune system; therefore the chronic
or routine use of corticosteroids/ciclosporin/NSAIDs should be avoided during
treatment.
Monitoring of clotting parameters after the first dose and once again after several
doses is recommended.
Methods of
administration
IV infusion over 1 hr. Each vial of mifamurtide should be reconstituted with 50ml NS.
The volume of reconstituted suspension corresponding to the calculated dose is
extracted through the filter provided and further diluted with an additional 50ml NS.
Side effects Immediate Short-term Long-term
Very common
Flu-like symptoms 51,
asthenia, chest pain/
discomfort
Nausea and vomiting 10,
constipation 11,
diarrhoea 12, abdominal
pain, musculoskeletal
stiffness/pain, dyspnoea 26,
cough 26, tachypnoea,
tachycardia, hyperhidrosis,
headache 34, dizziness,
hypotension/hypertension 54
Anorexia/weight loss 8 ,
anaemia 1
Common Infusion site
reactions 14, catheter
site pain, feeling cold,
flushing 18, pallor,
palpitations
Hypokalaemia 44,
paraesthesia, hypoaesthesia,
tremor, somnolence,
lethargy, blurred vision 38,
tinnitus, hearing loss 35,
cyanosis, phlebitis,
dyspepsia 7 , abdominal
distension, rash 19,
pruritus 21, erythema,
muscle spasm, haematuria,
dysuria, pollakiuria, oedema,
mucositis 6
Infections 5 , leucopenia 2 ,
thrombocytopenia 3 ,
dehydration, confusion,
depression, insomnia,
anxiety 33, pleural effusion,
haemoptysis, wheezing,
epistaxis 4 , nasal/sinus
congestion, cancer pain,
pharyngolaryngeal pain, liver
pain, alopecia 23, dry skin,
dysmenorrhoea 27
Uncommon None selected* None selected* None selected*
Rare None selected* Increased blood urea and
creatinine 30
None selected*
Very rare None selected* Subacute thrombosis None selected*
Unknown None selected* None selected* None selected*
Nursing implications ( 1
2
3
etc) see pages 20-29. *None selected for the purposes of this handbook
February 2014
104
MITOMYCIN
Generic name Mitomycin
Trade name Mitomycin CKyowa
Drug action Cytotoxic antibiotic.
Specific
information
Beware delayed recovery of BMD; toxicity is usually cumulative.
Methods of
administration
VESICANT AVOID EXTRAVASATION.
IV administration slow IV bolus in WFI or NS, the dose should be given as slowly as
possible and with great care in order to avoid extravasation.
IA; can be given directly into the tumours.
Intravesicular use in bladder cancer usually 20-40mg in 20-40ml WFI or NS is
instilled into the bladder via a urethral catheter. The dose should be retained for a
minimum of 1 hr.
Side effects Immediate Short-term Long-term
Very common Nausea and vomiting
(with high doses) 10
Nausea and vomiting 10,
diarrhoea 12, phlebitis 17
BMD (nadir 4 weeks) 1 2 3 ,
anorexia 8
Common None selected* None selected* Lethargy, asthenia,
fatigue 53, dermatitis 19,
pruritus 21, renal
impairment 30, stomatitis 6 ,
pulmonary disorders
(including pulmonary
oedema, interstitial
pneumonia and pulmonary
fibrosis) 26, weight loss
Uncommon None selected*
Skin reactions, alopecia 23,
haemorrhage, rash 19,
injection site reactions
(vascular pain, erythema,
blisters) 14
Liver and biliary tract
disorders following
administration to the hepatic
artery
Rare Hypersensitivity /
anaphylaxis 52
None selected* None selected*
Very rare None selected* None selected* None selected*
Unknown None selected*
Constipation 11 Cystitis and urinary/bladder
disorders following
intravesical administration,
acute leukaemia
Nursing implications ( 1
2
3
etc) see pages 20-29. *None selected for the purposes of this handbook
Lilly Handbook of Systemic Treatments for Cancer 8th Edition
105
MITOTANE
Generic name Mitotane
Trade name Lysodren
Drug action Antineoplastic agent biochemical mechanism unknown. Adrenal cytotoxic active
substance, also causes adrenal inhibition without cellular destruction.
Specific
information
Plasma levels should be monitored regularly and dose adjustments made in order
to reach therapeutic window with acceptable safety.
Mitotane is an enzyme inducer caution is advised in patients with hepatic
impairment and with concomitant administration of substances metabolised by
cytochrome P450.
Concomitant treatment with spironolactone must be avoided.
Methods of
administration
Oral. Tablets should be taken with water during meals containing food rich in fat.
Daily dose may be divided into 2 or 3 doses.
Advise patients not to use tablets showing signs of deterioration. Caregivers should
wear disposable gloves when handling tablets.
Side effects Immediate Short-term Long-term
Very common None selected*
Mucositis 6 , nausea and
vomiting 10, diarrhoea 12,
epigastric discomfort, ataxia,
paraesthesia, vertigo,
drowsiness, rash 19,
myasthenia, confusion,
leucopenia 2
Increased liver enzymes 24,
anorexia 8 , prolonged
bleeding time,
hypercholesterolemia 46,
hypertriglyceridaemia 46,
adrenal insufficiency ,
gynaecomastia 47
Common Dizziness,
headache 34
None selected*
Anaemia 1 ,
thrombocytopenia 3 , mental
impairment, polyneuropathy,
autoimmune hepatitis
Uncommon None selected* None selected* None selected*
Rare None selected* None selected* None selected*
Very rare None selected* None selected* None selected*
Unknown Hyperpyrexia,
generalised aching,
hypertension 54,
orthostatic
hypotension 54,
flushing 18
Salivary hypersecretion,
dysgeusia 7 , dyspepsia 9 ,
haemorrhagic cystitis 29,
haematuria, proteinuria
Decreased blood uric acid,
maculopathy, eye disorders
(retinal toxicity, diplopia,
lens opacity, visual
impairment) 38, thyroid
impairment, opportunistic
mycosis, liver damage 24
Nursing implications ( 1
2
3
etc) see pages 20-29. *None selected for the purposes of this handbook
February 2014
106
MITOXANTRONE
Generic name Mitoxantrone, mitozantrone
Trade name N/A
Drug action Anthracycline antibiotic derivative.
Specific
information
Cardiac examinations must be performed in patients who exceed a cumulative dose
of 160mg/m
2
or are at risk of cardiac toxicity.
Methods of
administration
EXFOLIANT AVOID EXTRAVASATION.
IV infusion over at least 3 mins, diluted in at least 50ml NS, D5W or DS.
Side effects Immediate Short-term Long-term
Very common None selected* None selected* None selected*
Common None selected* None selected* None selected*
Uncommon None selected* None selected* None selected*
Rare None selected* None selected* None selected*
Very rare None selected* None selected* None selected*
Unknown Anaphylaxis (caused
by sulphites) 52,
phlebitis 17
Blue-green urine (for
24 hrs) 28, anorexia 8 ,
nausea and vomiting 10,
diarrhoea 12,
constipation 11,
stomatitis 6 , mucositis,
GI haemorrhage, abdominal
pain, fever, blue
discolouration of nails, skin
and sclerae 28
Rash, dysgeusia,
somnolence, paraesthesia
(mild), confusion, anxiety,
alopecia, BMD (nadir 10
days) 1 2 3 , pruritus/dry
skin 21, amenorrhoea 27,
increased liver enzymes 24,
creatinine, uric acid and
BUN, cardiac toxicity (CHF,
decreased LVEF, ECG
changes, arrhythmia,
cardiomyopathy) 25
Nursing implications ( 1
2
3
etc) see pages 20-29. *None selected for the purposes of this handbook
N
Guide to frequency of side effects
Very common (1/10)
Common (1/100 to <1/10)
Uncommon (1/1000 to <1/100)
Rare (1/10,000 to <1/1,000)
Very rare (<1/10,000)
Unknown (cannot be estimated from the available data spontaneous reports)
Some (but not all) of the adverse events experienced with the drugs over time are listed
in the monographs. Please consult individual SPCs for full details.
Lilly Handbook of Systemic Treatments for Cancer 8th Edition
107
NELARABINE
Generic name Nelarabine
Trade name Atriance
Drug action Antimetabolite.
Specific
information
Risk of severe neurological reactions nelarabine must be discontinued at first sign
of neurological events of NCI CTCAE grade 2 or greater.
Patients should receive IV hydration according to standard medical practice for the
management of hyperuricaemia in patients at risk of tumour lysis syndrome. For
patients at risk of hyperuricaemia, the use of allopurinol should be considered.
Methods of
administration
IV infusion. Administer undiluted via a PVC or EVA infusion bag or glass container.
Infuse over 2 hrs in adults or 1 hr in children.
Side effects Immediate Short-term Long-term
Very common
Dyspnoea 26 Diarrhoea 12, nausea and
vomiting 10, constipation 11,
dizziness, headache 34,
cough
Infections (including sepsis,
bacteraemia, pneumonia,
fungal infections) 5 ,
BMD 1 2 3 , fatigue 53,
oedema, pain, peripheral
neuropathy 32, neurotoxicity
(somnolence, paraesthesia
and hypoaesthesia) 33
Common None selected*
Tumour lysis syndrome 31,
hypocalcaemia 41,
hypomagnesaemia 42,
hypokalaemia 44,
anorexia 8 , amnesia,
hypotension 54, pleural
effusion, wheezing,
stomatitis 6 , abdominal
pain 34
Fever 5 , seizures,
confusion, balance disorder,
tremor, dysgeusia 7 ,
blurred vision 38,
musculoskeletal pain,
increased LFTs and
creatinine 24
Uncommon None selected* None selected* None selected*
Rare None selected* None selected* None selected*
Very rare None selected* None selected* None selected*
Unknown None selected* None selected* None selected*
Nursing implications ( 1
2
3
etc) see pages 20-29. *None selected for the purposes of this handbook
February 2014
108
NILOTINIB
Generic name Nilotinib
Trade name Tasigna
Drug action BCR-ABL tyrosine kinase inhibitor.
Specific
information
Nilotinib can cause QT prolongation. Baseline ECG and continued monitoring are
recommended as clinically indicated.
Nilotinib is primarily metabolised by hepatic cytochrome P450 CYP3A4 enzymes.
Drugs that are inhibitors or inducers of these enzymes may interact with nilotinib.
Avoid grapefruit juice.
Methods of
administration
Oral. Capsules should be swallowed whole with water. No food should be consumed
for 2 hrs before dose is taken or at least 1 hr after. For patients with swallowing
difficulties, the contents of the capsule can be dispersed in 1 teaspoon of apple
sauce (pureed apple), and taken immediately.
Side effects Immediate Short-term Long-term
Very common None selected*
Headache 34, nausea 10 BMD 1 2 3 ,
hypophosphataemia,
hyperbilirubinaemia,
rash 19, pruritus 21, dry
skin, alopecia, myalgia,
fatigue
Common None selected*
Vomiting 10, diarrhoea 12,
constipation 11, abdominal
pain, dyspepsia 9 ,
dyspnoea, cough 26,
flushing 18, peripheral
oedema
Cardiac disorders
(QT prolongation,
arrhythmia, palpitations) 25,
muscle spasm, arthralgia 34,
pain in extremity, asthenia,
hypokalaemia 44, diabetes,
hypercholesterolaemia 46,
hyperlipidaemia 46,
hyperglycaemia 39,
abnormal LFTs
Uncommon None selected* None selected* Pleural and pericardial
effusions 25 26
Rare None selected* None selected* None selected*
Very rare None selected* None selected* None selected*
Unknown
Hypersensitivity 52 None selected* None selected*
Nursing implications ( 1
2
3
etc) see pages 20-29. *None selected for the purposes of this handbook
O
Guide to frequency of side effects
Very common (1/10)
Common (1/100 to <1/10)
Uncommon (1/1000 to <1/100)
Rare (1/10,000 to <1/1,000)
Very rare (<1/10,000)
Unknown (cannot be estimated from the available data spontaneous reports)
Some (but not all) of the adverse events experienced with the drugs over time are listed
in the monographs. Please consult individual SPCs for full details.
Lilly Handbook of Systemic Treatments for Cancer 8th Edition
109
OFATUMUMAB
Generic name Ofatumumab
Trade name Arzerra
Drug action Monoclonal antibody specific for the CD20 molecule expressed on B-lymphocytes.
Specific
information
Patients should be premedicated with an analgesic, antihistamine and corticosteroid
30-120 mins prior to ofatumumab infusion to reduce the risk of hypersensitivity.
May cause tumour lysis if there is a high tumour burden.
Methods of
administration
IV infusion diluted in 1L NS and administer using the 0.2 micron in-line filter
provided.
First and second infusions: start infusion at 12ml/hr. Double rate every 30 mins to
max 200ml/hr.
Subsequent infusions: start infusion at 25ml/hr. Double rate every 30 mins to max
400ml/hr.
Rates of infusion will be dependent on patient tolerability. If adverse reactions are
observed, infusion should be restarted at 12ml/hr and increased as above if
tolerated.
Side effects Immediate Short-term Long-term
Very common
Hypersensitivity 52 None selected*
RTI 5 , rash, neutropenia 2 ,
anaemia 1
Common
Anaphylaxis 52,
cytokine release
syndrome,
pharyngolaryngeal
pain, cough 26,
hypotension/
hypertension 54
Small bowel obstruction,
diarrhoea 12 , nausea 10
Sepsis 5 , herpes virus
infections 5 , UTI 5 ,
thrombocytopenia 3 ,
leucopenia, back pain
Uncommon None selected*
Tumour lysis syndrome 31 Agranulocytosis,
coagulopathy, red cell
aplasia, lymphopenia
Rare None selected* None selected* Hepatitis B infections and
reactivation
Very rare None selected* None selected* None selected*
Unknown None selected* None selected* None selected*
Nursing implications ( 1
2
3
etc) see pages 20-29. *None selected for the purposes of this handbook
February 2014
110
OXALIPLATIN
Generic name Oxaliplatin
Trade name Eloxatin
Drug action Platinum compound that forms crosslinks with DNA, thereby disrupting DNA
synthesis.
Specific
information
N/A
Methods of
administration
EXFOLIANT AVOID EXTRAVASATION.
IV infusion over 2-6 hrs in D5W. Do NOT dilute with NS or chloride-containing
solutions.
Side effects Immediate Short-term Long-term
Very common Pharyngolaryngeal
dysaesthesia
(dysphagia, dyspnoea,
laryngeal spasm),
acute peripheral
neuropathy (avoid
cold air) 32,
hypersensitivity 52,
anaphylaxis 52
Nausea and vomiting 10,
diarrhoea 12,
constipation 11,
stomatitis 6 , injection site
reactions 14, anorexia 8 ,
epistaxis 4 , alopecia 23,
hypokalaemia 44, fatigue 53,
back pain
BMD 1 2 3 , abnormal
LFTs, dose-cumulative
peripheral neuropathy 32
Common None selected*
Dyspepsia 9 , depression,
insomnia 33,
haemorrhage 4 ,
haematuria, desquamation/
PPE 20, bone pain 34,
arthralgia 34
Nail disorders 15
Uncommon None selected* None selected* None selected*
Rare None selected* None selected* None selected*
Very rare None selected* None selected* None selected*
Unknown None selected* None selected* None selected*
Nursing implications ( 1
2
3
etc) see pages 20-29. *None selected for the purposes of this handbook
P
Guide to frequency of side effects
Very common (1/10)
Common (1/100 to <1/10)
Uncommon (1/1000 to <1/100)
Rare (1/10,000 to <1/1,000)
Very rare (<1/10,000)
Unknown (cannot be estimated from the available data spontaneous reports)
Some (but not all) of the adverse events experienced with the drugs over time are listed
in the monographs. Please consult individual SPCs for full details.
Lilly Handbook of Systemic Treatments for Cancer 8th Edition
111
PACLITAXEL ALBUMIN
Generic name Paclitaxel albumin
Trade name Abraxane
Drug action Taxane, inhibitor of mitosis.
Specific
information
Paclitaxel albumin is an albumin-bound nanoparticle formulation of paclitaxel,
which is different to other formulations of paclitaxel. It should NOT be substituted
for or with other paclitaxel formulations.
Methods of
administration
IV infusion over 30 mins.
No diluent in final bag for infusion. The reconstituted paclitaxel albumin (Abraxane)
will appear as a milky suspension.
Side effects Immediate Short-term Long-term
Very common None selected*
Nausea and vomiting 10,
diarrhoea 12,
constipation 11,
stomatitis 6 , fever,
fatigue 53, asthenia, rash 19,
alopecia 23
BMD 1 2 3 , anorexia 8 ,
peripheral neuropathy 32,
musculoskeletal pain 34
Common None selected* Abdominal pain and
distension, dyspepsia 9
Infections 5 , headache 34,
dizziness, ataxia,
dehydration, increased
lacrimation, blurred
vision 38, dry eyes 38,
increased appetite,
hypokalaemia 44,
arrhythmia 25, pain in the
extremities 34, muscle
cramps, nail disorders,
pruritus 21, dry skin,
hyperpigmentation,
insomnia, depression,
anxiety, somnolence,
increased liver enzymes 24,
flushing 18, hypertension 54,
lymphoedema, dyspnoea 26,
epistaxis, cough, rhinitis
Uncommon
Hypersensitivity 52 None selected* None selected*
Rare None selected* None selected* None selected*
Very rare None selected* None selected* None selected*
Unknown None selected* None selected* None selected*
Nursing implications ( 1
2
3
etc) see pages 20-29. *None selected for the purposes of this handbook
February 2014
112
PACLITAXEL NON-ALBUMIN
Generic name Paclitaxel
Trade name N/A
Drug action Taxane, inhibitor of mitosis.
Specific
information
Patients should be pre-medicated with a corticosteroid, an antihistamine and an
H
2
-antagonist 30-60 mins prior to infusion.
Contains 49.7% vol ethanol.
Methods of
administration
VESICANT AVOID EXTRAVASATION.
Administer paclitaxel first when given in combination with cisplatin.
IV infusion in 250-500ml NS, D5W or DS.
Infuse over 1-3 hrs or according to protocol. Some protocols may infuse over up to
24 hrs.
Must be administered in a non-PVC container using a non-PVC administration set
with 0.22 micron filter (paclitaxel causes leaching of chemicals from PVC).
Excessive shaking or agitation should be avoided.
Inspect prepared solution for precipitation regularly during infusion.
Side effects Immediate Short-term Long-term
Very common Minor hypersensitivity
(mainly flushing and
rash) 52
Nausea and vomiting 10,
diarrhoea 12, mucositis 6 ,
hypotension 54
BMD 1 2 3 , infections
(mainly UTI and upper RTI),
alopecia (total) 23,
musculoskeletal pain 34,
peripheral neuropathy 32
Common Injection site
reactions 14,
bradycadia
Increased liver enzymes 24,
transient and mild nail and
skin changes 15
None selected*
Uncommon Severe
hypersensitivity 52
(urticaria, dyspnoea,
hypotension, chest
pain)
Septic shock
Cardiac disorders 25,
hypertension 54, thrombosis,
thrombophlebitis 17
Rare Anaphylaxis, cardiac
conduction
abnormality 25
None selected* None selected*
Very rare None selected* None selected* None selected*
Unknown None selected* None selected* None selected*
Nursing implications ( 1
2
3
etc) see pages 20-29. *None selected for the purposes of this handbook
Lilly Handbook of Systemic Treatments for Cancer 8th Edition
113
PANITUMUMAB
Generic name Panitumumab
Trade name Vectibix
Drug action Monoclonal antibody specific for EGFR.
Specific
information
Panitumumab should only be administered to patients that express non-mutated
(wild-type) KRAS gene.
Dose reduction or discontinuation recommended for dermatologic reactions NCI
CTCAE grade 3 or above.
Methods of
administration
Dilute in NS to a final concentration not exceeding 10mg/ml and give via IV infusion
using 0.2 or 0.22 micron in-line filter. On the first cycle, administer over 60 mins. If
tolerated, subsequent cycles can be administered over 30-60 mins. Doses over 1g
should be administered over 90 mins. Infusion set should be flushed with NS before
and after administration.
Side effects Immediate Short-term Long-term
Very common None selected*
Nausea and vomiting 10,
diarrhoea 12,
constipation 11, abdominal
pain, stomatitis 6 ,
fatigue 53, conjunctivitis 38,
dyspnoea, cough 26, fever,
mucositis 6
Rash 19, acne 17, erythema,
pruritus 21, dry skin,
alopecia 23, paronychia,
anaemia 1 ,
hypomagnesaemia 42,
hypokalaemia 44,
anorexia 8 , insomnia, back
pain 34, peripheral oedema
Common Infusion-related
reactions 52,
hypersensitivity 52,
tachycardia
Cellulitis, folliculitis, anxiety,
headache 34, dizziness,
epistaxis, dyspepsia 9
Leucopenia,
hypocalcaemia 41,
dehydration,
hyperglycaemia 39,
hypophosphataemia 46,
thrombosis, PPE 20,
blepharitis, dry eye 38, eye
pruritus, ocular hyperaemia,
growth of eyelashes, eye
irritation, increased
lacrimation 38
Uncommon None selected* None selected* None selected*
Rare
Anaphylaxis 52 None selected* Skin necrosis
Very rare None selected* None selected* None selected*
Unknown None selected* None selected* None selected*
Nursing implications ( 1
2
3
etc) see pages 20-29. *None selected for the purposes of this handbook
February 2014
114
PAZOPANIB
Generic name Pazopanib
Trade name Votrient
Drug action Multi-target tyrosine kinase inhibitor (VEGF receptors 1, 2 and 3,
PDGF receptor /, C-KIT).
Specific
information
BP should be well controlled before initiating pazopanib; frequent monitoring
recommended.
Avoid concomitant treatment with strong inhibitors or inducers of cytochrome
P450 CYP3A4.
Methods of
administration
Oral. Tablets should be taken at least 1 hr before or 2 hrs after a meal.
Avoid grapefruit juice.
Side effects Immediate Short-term Long-term
Very common None selected*
Nausea and vomiting 10,
abdominal pain,
diarrhoea 12, dysgeusia 7 ,
hypertension 54,
headache 34
Anorexia 8 , fatigue 53, hair
colour change, alopecia 23,
PPE 20, rash 19, increased
LFTs 24
Common None selected*
Flushing 18, epistaxis,
haemoptysis, dyspnoea 26,
dyspepsia 9 , stomatitis,
flatulence, abdominal
distension
BMD 2 3 , VTE,
paraesthesia 32, dizziness,
lethargy, musculoskeletal
pain, muscle spasm, skin
hypopigmentation,
pruritus 21, hyperhidrosis,
hypothyroidism 45,
proteinuria,
hypophosphataemia 46,
dehydration, insomnia,
blurred vision 38
Uncommon None selected* None selected* None selected*
Rare None selected* None selected* None selected*
Very rare None selected* None selected* None selected*
Unknown None selected* None selected* None selected*
Nursing implications ( 1
2
3
etc) see pages 20-29. *None selected for the purposes of this handbook
Lilly Handbook of Systemic Treatments for Cancer 8th Edition
115
PEMETREXED
Generic name Pemetrexed
Trade name Alimta
Drug action Antimetabolite.
Specific
information
Premedication: corticosteroid (dexamethasone 4mg) orally twice daily for 3 days
starting the day before pemetrexed; folic acid 350-1,000 microgram once daily
(5 doses must be given prior to pemetrexed and continued for 21 days after last
dose); vitamin B
12
1g IM in week preceding first dose then once every 3 cycles
thereafter. Subsequent vitamin B
12
injections may be administered on the same day
as pemetrexed.
Caution with other renally excreted drugs including NSAIDs, which should be
omitted for at least 2 days either side of treatment. NSAIDs with long elimination
half-lives (eg, piroxicam) should be interrupted for at least 5 days prior and 2 days
after pemetrexed treatment.
Methods of
administration
IV infusion over 10 mins in 100ml NS.
Side effects Immediate Short-term Long-term
Very common None selected*
Nausea and vomiting 10,
diarrhoea 12,
constipation 11, anorexia 8 ,
stomatitis 6 , pharyngitis,
fatigue 53, rash 19,
pruritus 21, alopecia 23
BMD 1 2 3 ,
neuropathy 32, increased
creatinine, decreased
creatinine clearance
Common
Hypersensitivity 52 Fever, dehydration,
conjunctivitis, dysgeusia,
dyspepsia 9
Abnormal LFTs 24
Uncommon None selected*
Nephrotoxicity 30 Peripheral ischaemia
Rare None selected* None selected* None selected*
Very rare
Anaphylaxis 52 Stevens-Johnson syndrome/
TEN 22
None selected*
Unknown None selected* None selected* None selected*
Nursing implications ( 1
2
3
etc) see pages 20-29. *None selected for the purposes of this handbook
February 2014
116
PENTOSTATIN
Generic name Pentostatin
Trade name Nipent
Drug action Antimetabolite.
Specific
information
Hydration required pre- and post-administration.
Men should not father a child during and up to six months after treatment.
Women of childbearing age must use definitive contraception.
Combination of pentostatin with fludarabine phosphate or high-dose
cyclophosphamide is not recommended owing to the risk of potentially fatal
adverse reactions.
Methods of
administration
Slow IV bolus over 5 mins or infuse over 20-30 mins.
Side effects Immediate Short-term Long-term
Very common None selected* Infections, abdominal pain,
diarrhoea 12, rash 19,
pruritus 21, asthenia 51,
fever 51, chills 51,
headache 34, cough, CNS
toxicity 33
BMD 1 2 3 , hepatic
impairment 24
Common
Flushing 18 Nausea and vomiting 10,
constipation 11,
dyspepsia 9 , fatigue/
malaise 53, mood changes,
anorexia 8 , musculoskeletal
pain, respiratory disorders,
peripheral oedema,
thrombophlebitis 17,
nephrotoxicity (including
dysuria, haematuria) 30, eye
disorders, ear disorders
Cardiac toxicity 25,
neoplasms (including skin
carcinoma)
Uncommon None selected*
Tumour lysis syndrome 31,
haemorrhagic cystitis 29
None selected*
Rare None selected* Oesophageal candidiasis None selected*
Very rare None selected* None selected* None selected*
Unknown None selected* None selected* None selected*
Nursing implications ( 1
2
3
etc) see pages 20-29. *None selected for the purposes of this handbook
Lilly Handbook of Systemic Treatments for Cancer 8th Edition
117
PERTUZUMAB
Generic name Pertuzumab
Trade name Perjeta
Drug action Monoclonal antibody specific for EGFR 2 (HER2), mediates antibody-dependent
cell-mediated cytotoxicity. When combined with trastuzumab, which also targets
EGFR 2, antitumour activity is increased.
Specific
information
Observe closely for hypersensitivity for 60 mins after the first infusion then for 30
mins after subsequent infusions.
Decreases in LVEF have been reported. Assess LVEF before and every 3 cycles
during treatment.
Methods of
administration
Initially given as an IV infusion over 1 hr, followed every 3 weeks thereafter by an IV
infusion over 30-60 mins.
Side effects Immediate Short-term Long-term
Very common Hypersensitivity/
anaphylaxis 52,
infusion-related
reactions/cytokine
release syndrome
Upper RTI, BMD 1 2 3 ,
anorexia 8 , peripheral
neuropathy, dysgeusia 7 ,
dizziness, headache 34,
increased lacrimation 38,
dyspnoea, cough 26,
constipation 11, nausea and
vomiting 10, dyspepsia 7 ,
diarrhoea 12, stomatitis 6 ,
rash 19, pain 34, mucositis,
oedema, fever, fatigue 53
Arthritis, myalgia 34,
alopecia 23, dry skin,
insomnia
Common None selected* Chills
Paronychia, LVD, CHF 25,
pleural effusion 26
Uncommon None selected* None selected* ILD
Rare None selected* None selected* None selected*
Very rare None selected* None selected* None selected*
Unknown None selected* None selected* None selected*
Nursing implications ( 1
2
3
etc) see pages 20-29. *None selected for the purposes of this handbook
February 2014
118
PIXANTRONE
Generic name Pixantrone
Trade name Pixuvri
Drug action Aza-anthracenedione (anthracycline-related substance).
Specific
information
N/A
Methods of
administration
Slow IV infusion using a 0.2 micron pore size in-line filter over a minimum of 60
mins after dilution with NS to a final volume of 250ml.
Side effects Immediate Short-term Long-term
Very common Asthenia
Nausea and vomiting 10,
skin discolouration 16,
alopecia 23, chromaturia
BMD 1 2 3
Common
Fatigue 53, mucositis,
fever, chest pain 25,
oedema
Dysgeusia 7 , paraesthesia,
headache 34, somnolence,
conjunctivitis, cardiac
disorders 25, dyspnoea,
cough 26, stomatitis 1 ,
diarrhoea 12,
constipation 11, abdominal
pain 34, dry mouth,
dyspepsia 7 , erythema, nail
disorders 15, pruritus 21,
bone pain, proteinuria,
haematuria
Anorexia 8 ,
hypophosphataemia 42
Uncommon
Hypersensitivity 52,
chills, injection site
coldness 14, local
reactions
Anxiety, sleep disorders 33,
dizziness, lethargy, pleural
effusion, pneumonitis 26,
rhinorrhoea, arrhythmia 25,
vascular disorders,
hyperbilirubinaemia,
oliguria, spontaneous
erection 27
Hyperuricaemia 40,
hypocalcaemia 41,
hyponatraemia
Rare None selected* None selected* None selected*
Very rare None selected* None selected* None selected*
Unknown None selected* None selected* None selected*
Nursing implications ( 1
2
3
etc) see pages 20-29. *None selected for the purposes of this handbook
Lilly Handbook of Systemic Treatments for Cancer 8th Edition
119
POMALIDOMIDE
Generic name Pomalidomide
Trade name Imnovid
Drug action Has direct anti-myeloma tumouricidal activity, immunomodulatory activities and
inhibits stromal cell support for multiple myeloma tumour cell growth.
Pomalidomide also inhibits angiogenesis by blocking the migration and adhesion of
endothelial cells.
Specific
information
Pomalidomide causes severe and life-threatening birth defects. Both female and
male patients must be enrolled in the Imnovid Pregnancy Prevention Programme
and a Prescription Authorisation Form must be completed with every prescription.
Methods of
administration
Oral. Capsules should be swallowed whole, with or without food.
Side effects Immediate Short-term Long-term
Very common None selected*
Dyspnoea, cough 26,
diarrhoea 12, nausea 10,
constipation 11, bone pain,
muscle spasm, fatigue 53,
fever, peripheral oedema
Pneumonia 26,
BMD 1 2 3 , anorexia 8
Common None selected* Rash, pruritus
Neutropenic sepsis 5 , RTI,
hyperkalaemia 44,
hyponatraemia, renal
impairment, urinary
retention, pelvic pain,
confusion, reduced
consciousness, peripheral
neuropathy 32, dizziness,
tremor, DVT, pulmonary
embolism, increased ALT
Uncommon None selected* None selected* Hyperbilirubinaemia
Rare None selected* None selected* None selected*
Very rare None selected* None selected* None selected*
Unknown None selected* None selected* None selected*
Nursing implications ( 1
2
3
etc) see pages 20-29. *None selected for the purposes of this handbook
February 2014
120
PONATINIB
Generic name Ponatinib
Trade name Iclusig
Drug action Bcr-Abl tyrosine kinase inhibitor.
Specific
information
Caution is advised with concurrent use of moderate/strong inhibitors and strong
inducers of cytochrome P450 CYP3A4. Ponatinib may also increase plasma
concentrations of co-administered substrates of P-gp or BCRP. Products that
elevate gastric pH (such as PPIs, H
2
blockers and antacids) may decrease the
solubility of ponatinib and thus reduce its bioavailability.
Methods of
administration
Oral. Tablets should be swallowed whole, with or without food.
Side effects Immediate Short-term Long-term
Very common None selected*
Dyspnoea, cough 26,
headache 34, abdominal
pain 34, diarrhoea 12,
nausea and vomiting 10,
constipation 11, increased
lipase and ALT 24,
anorexia 8
BMD 1 2 3 ,
hypertension 54, rash 19, dry
skin, musculoskeletal
pain 34, pain in extremity,
fatigue 53, asthenia,
peripheral oedema, fever
Common None selected*
Blurred vision, dry eye 38,
GORD, dyspepsia, abdominal
distension/discomfort, dry
mouth, insomnia, lethargy,
dizziness, migraine 34, atrial
fibrillation 25, decreased
LVEF 25, hot flushes,
flushing 18, erythema,
pruritus 21, skin pain,
periorbital oedema, chills,
flu-like symptoms 51, chest
pain, pain, mass, face
oedema
Pancreatitis, stomatitis 6 ,
increased blood amylase and
LFTs 24, RTI 26, sepsis,
folliculitis, peripheral
neuropathy, hyperaesthesia,
hypoaesthesia, paraesthesia,
cardiac failure, MI, coronary
artery disease, angina 25,
pericardial and pleural
effusion, DVT, epistaxis 4 ,
dysphonia, fluid and
electrolyte
disturbances 42 44,
hypocalcaemia 41,
hyperglycaemia 39,
hyperuricaemia 40,
hypertriglyceridaemia,
weight loss 8 , alopecia 23,
night sweats, hyperhidrosis,
petechiae, ecchymosis,
muscle spasm, erectile
dysfunction 27
Uncommon None selected*
Tumour lysis syndrome 31,
eyelid oedema
Cerebral infarction, cerebral
artery stenosis, retinal vein
thrombosis, LVD, embolism,
gastric haemorrhage,
hepatotoxicity 24, exfoliative
dermatitis
Rare None selected* None selected* None selected*
Very rare None selected* None selected* None selected*
Unknown None selected* None selected* None selected*
Nursing implications ( 1
2
3
etc) see pages 20-29. *None selected for the purposes of this handbook
Lilly Handbook of Systemic Treatments for Cancer 8th Edition
121
PROCARBAZINE
Generic name Procarbazine
Trade name N/A
Drug action Cytostatic.
Specific
information
Weak MAO inhibitor properties may interact with certain drugs and foods
containing tyramine.
Intolerance to alcohol (disulfiram-like reaction) may occur.
Methods of
administration
Oral.
A suspension can be made in some aseptic units. This is an unlicensed formulation.
Ref: NEWT guidelines
Side effects Immediate Short-term Long-term
Very common None selected*
Nausea and vomiting 10,
anorexia 8 (all usually
transient)
None selected*
Common None selected* None selected*
BMD 1 2 3
Uncommon None selected* None selected* None selected*
Rare None selected* None selected* None selected*
Very rare None selected* None selected*
Hypersensitivity 52
Unknown Mild tyramine
reactions (facial
flushing 18, itchy
rash 19 ), severe
tyramine reactions 43
(sudden headache,
pounding heart, stiff
neck, sweating,
shivering, chills,
sensitivity to light,
nausea and vomiting)
None selected*
Abnormal LFTs 24
Nursing implications ( 1
2
3
etc) see pages 20-29. *None selected for the purposes of this handbook
R
Guide to frequency of side effects
Very common (1/10)
Common (1/100 to <1/10)
Uncommon (1/1000 to <1/100)
Rare (1/10,000 to <1/1,000)
Very rare (<1/10,000)
Unknown (cannot be estimated from the available data spontaneous reports)
Some (but not all) of the adverse events experienced with the drugs over time are listed
in the monographs. Please consult individual SPCs for full details.
Lilly Handbook of Systemic Treatments for Cancer 8th Edition
123
RALTITREXED
Generic name Raltitrexed
Trade name Tomudex
Drug action Antimetabolite.
Specific
information
Avoid folic acid and folinic acid supplements immediately before and during
administration.
Extreme care should be taken to ensure adequate monitoring of adverse reactions
especially signs of GI toxicity (diarrhoea or mucositis) and BMD (neutropenia,
thrombocytopenia and infections).
Methods of
administration
Short IV infusion in 50-250ml NS or D5W over 15 mins.
Side effects Immediate Short-term Long-term
Very common None selected*
Nausea and vomiting 10,
anorexia 8 , diarrhoea 12,
rash 19, pruritus, abdominal
pain, fever, flu-like
symptoms 51
Neutropenia 2 , anaemia 1 ,
arthralgia, hypertonia,
fatigue/malaise 53, asthenia,
increased LFTs 24
Common None selected*
Desquamation, headache 34,
mucositis 6 , infections 5 ,
sweating, cellulitis,
conjunctivitis 38
Thrombocytopenia 3 ,
alopecia 23 , dysgeusia 7
Uncommon None selected* None selected* None selected*
Rare None selected* None selected* None selected*
Very rare None selected* None selected* None selected*
Unknown None selected* None selected* None selected*
Nursing implications ( 1
2
3
etc) see pages 20-29. *None selected for the purposes of this handbook
February 2014
124
REGORAFENIB
Generic name Regorafenib
Trade name Stivarga
Drug action Multi-target protein kinase inhibitor with anti-angiogenic and anti-proliferative
activity.
Specific
information
Regorafenib is metabolised by cytochrome P450 CYP3A4 and uridine diphosphate
glucuronosyl transferase UGT1A9. Inducers and inhibitors of these enzymes may
affect the metabolism of regorafenib resulting in decreased or increased effect.
Monitor BP and proteinuria.
Methods of
administration
Oral. Tablets should be swallowed whole after a light meal that contains less than
30% fat.
Side effects Immediate Short-term Long-term
Very common None selected*
Infections 5 ,
thrombocytopenia 3 ,
haemorrhage,
hypertension 54,
headache 34, diarrhoea 12,
PPE 20, rash 19, pain, fever
Anaemia 1 , anorexia 8 ,
stomatitis 6 , mucositis,
dysphonia,
hyperbilirubinaemia,
asthenia/fatigue,
weight loss 8
Common None selected*
Leucopenia 2 ,
hypokalaemia 44,
hypophosphataemia,
hypocalcaemia 41,
hyponatraemia,
hypomagnesaemia 42,
hyperuricaemia, tremor,
dysgeusia, dry mouth, GORD,
gastroenteritis, exfoliative
rash, proteinuria, increased
amylase, lipase and
transaminases 24,
abnormal INR
Hypothyroidism 45, dry skin,
alopecia 23,
nail disorders 15,
musculoskeletal stiffness
Uncommon Hypertensive crisis GI perforation, GI fistula,
erythema multiforme
MI, myocardial ischaemia 25,
severe liver injury
Rare None selected* None selected* None selected*
Very rare None selected* None selected* None selected*
Unknown None selected* None selected* None selected*
Nursing implications ( 1
2
3
etc) see pages 20-29. *None selected for the purposes of this handbook
Lilly Handbook of Systemic Treatments for Cancer 8th Edition
125
RITUXIMAB
Generic name Rituximab
Trade name MabThera
Drug action Monoclonal antibody specific for the CD20 antigen on B lymphocytes.
Specific
information
Premedicate with an analgesic, antihistamine and corticosteroid 30-60 mins prior to
infusion if not co-administered as part of chemotherapy. May cause tumour lysis
syndrome if there is a high tumour burden.
Methods of
administration
IV infusion in NS or D5W start first infusion at 50mg/hr then, if well tolerated,
escalate every 30 mins in 50mg/hr increments, to a maximum of 400mg/hr.
Start subsequent infusions at 100mg/hr, and increase every 30 mins in 100mg/hr
increments, to a maximum of 400mg/hr.
Side effects Immediate Short-term Long-term
Very common None selected*
Nausea 10, pruritus 21,
rash 19, alopecia 23, fever,
chills, asthenia,
headache 34, infections/
sepsis 5
Leucopenia 2 ,
thrombocytopenia 3
Common None selected*
Vomiting 10, diarrhoea,
hypotension/
hypertension 54,
angioedema, peripheral
oedema, hyperglycaemia,
dizziness, paraesthesia, back
pain 34, abdominal pain 34,
arthralgia 34, cardiac
events 25
Anaemia 1
Uncommon None selected* None selected* None selected*
Rare None selected* None selected* None selected*
Very rare None selected*
Severe skin reactions 22,
progressive multifocal
leukoencephalopathy
None selected*
Unknown Cytokine release
syndrome (dyspnoea,
bronchospasm,
hypoxia) and
infusion-related
reactions 52
interrupt infusion
immediately if severe
None selected* None selected*
Nursing implications ( 1
2
3
etc) see pages 20-29. *None selected for the purposes of this handbook
February 2014
126
RUXOLITINIB
Generic name Ruxolitinib
Trade name Jakavi
Drug action Selective inhibitor of the Janus-associated tyrosine kinases JAK1 and JAK2.
Specific
information
Ruxolitinib is metabolised by hepatic cytochrome P450 enzymes. Drugs that are
inhibitors or inducers of these enzymes may interact with ruxolitinib.
Symptoms of myelofibrosis may return over a period of approximately 1 week
following dose interruption/discontinuation. Gradual tapering of the dose may be
considered unless abrupt discontinuation is required, although the utility of the
tapering is unproven.
Methods of
administration
Oral. Tablets can be taken with or without food.
Side effects Immediate Short-term Long-term
Very common None selected*
UTI, bruising 4 , dizziness,
headache 34, increased AST
and ALT 24
Weight gain,
hypercholesterolaemia,
BMD 1 2 3 , haemorrhage
(including intracranial
and GI)
Common None selected* Flatulence, herpes zoster None selected*
Uncommon None selected* None selected* Tuberculosis
Rare None selected* None selected* None selected*
Very rare None selected* None selected* None selected*
Unknown None selected* None selected* None selected*
Nursing implications ( 1
2
3
etc) see pages 20-29. *None selected for the purposes of this handbook
S
Guide to frequency of side effects
Very common (1/10)
Common (1/100 to <1/10)
Uncommon (1/1000 to <1/100)
Rare (1/10,000 to <1/1,000)
Very rare (<1/10,000)
Unknown (cannot be estimated from the available data spontaneous reports)
Some (but not all) of the adverse events experienced with the drugs over time are listed
in the monographs. Please consult individual SPCs for full details.
Lilly Handbook of Systemic Treatments for Cancer 8th Edition
127
SORAFENIB
Generic name Sorafenib
Trade name Nexavar
Drug action Multi-target tyrosine kinase inhibitor.
Specific
information
N/A
Methods of
administration
Oral. Tablets should be swallowed whole without food or with a low/moderate fat
meal. If the patient intends to have a high fat meal, tablets should be taken at least
1 hr before or 2 hrs after.
Side effects Immediate Short-term Long-term
Very common None selected*
Lymphopenia 2 ,
diarrhoea 12, nausea and
vomiting 10,
hypophosphataemia, PPE 20,
rash 19, pruritus
Hypertension 54,
haemorrhage 4
Common None selected*
BMD 1 2 3 , dry skin,
acne, desquamation,
stomatitis 6 , tinnitus 35,
myalgia/asthenia, fever,
flu-like symptoms 51
Renal impairment 30,
erectile dysfunction 27
Uncommon None selected*
Hypersensitivity 52 Pulmonary complications 27,
abnormal LFTs 24
Rare None selected* None selected* None selected*
Very rare None selected* None selected* None selected*
Unknown None selected* None selected* None selected*
Nursing implications ( 1
2
3
etc) see pages 20-29. *None selected for the purposes of this handbook
February 2014
128
STREPTOZOCIN
Generic name Streptozocin
Trade name Zanosar
Drug action Alkylating agent.
Specific
information
No longer licensed in the UK but available on a named-patient basis.
Pancreatic toxicity may cause diabetogenic effect.
Methods of
administration
VESICANT AVOID EXTRAVASATION.
IV infusion over 30-60 mins in NS or D5W.
Side effects Immediate Short-term Long-term
Very common Burning along vein
during rapid infusion
if extravasated 14,
hypoglycaemia if
infused too rapidly 39
Hypoglycaemia/
hyperglycaemia 39, severe
nausea and vomiting 10,
diarrhoea 12
Nephrotoxicity
(proteinuria, azotaemia,
hypophosphataemia,
glycosuria, renal tubular
acidosis) 30, infertility 27
Common None selected*
Confusion and lethargy 33,
depression 33
Abnormal LFTs 12,
BMD 1 2 3 , alopecia 23,
stomatitis 6 , dysgeusia 7
Uncommon None selected* None selected* None selected*
Rare None selected* None selected* None selected*
Very rare None selected* None selected* None selected*
Unknown None selected* None selected* None selected*
Nursing implications ( 1
2
3
etc) see pages 20-29. *None selected for the purposes of this handbook
Lilly Handbook of Systemic Treatments for Cancer 8th Edition
129
SUNITINIB
Generic name Sunitinib
Trade name Sutent
Drug action Multi-target tyrosine kinase inhibitor.
Specific
information
Administration of potent cytochrome P450 CYP3A4 inhibitors/inducers should be
avoided as may increase or decrease sunitinib concentrations.
Yellow discolouration and depigmentation of hair or skin may occur with sunitinib.
Moisturise hands and feet from beginning of treatment.
Methods of
administration
Oral. Capsules should be swallowed whole, with or without food.
Side effects Immediate Short-term Long-term
Very common None selected*
Fatigue 53, diarrhoea 12,
nausea and vomiting 10,
stomatitis 6 , dyspepsia 9 ,
dysgeusia 7 , dry skin,
headache 34, epistaxis
Hypertension 54,
hypothyroidism 45, skin and
hair discolouration 16 23,
PPE 20, neutropenia 2 ,
thrombocytopenia 3
Common None selected* Pulmonary embolism,
tumour haemorrhage,
hypothyroidism 45, dizziness,
cough 26, myalgia, renal
impairment 30, oesophagitis
Peripheral neuropathy 32
Uncommon None selected* None selected* Pancreatitis, hepatic
impairment 54, cardiac
failure/cardiomyopathy 25
Rare None selected* None selected*
QT prolongation 25
Very rare None selected* Stevens-Johnson syndrome/
TEN 22
None selected*
Unknown Angioedema,
hypersensitivity 52
None selected* None selected*
Nursing implications ( 1
2
3
etc) see pages 20-29. *None selected for the purposes of this handbook
T
Guide to frequency of side effects
Very common (1/10)
Common (1/100 to <1/10)
Uncommon (1/1000 to <1/100)
Rare (1/10,000 to <1/1,000)
Very rare (<1/10,000)
Unknown (cannot be estimated from the available data spontaneous reports)
Some (but not all) of the adverse events experienced with the drugs over time are listed
in the monographs. Please consult individual SPCs for full details.
Lilly Handbook of Systemic Treatments for Cancer 8th Edition
131
TEGAFUR/GIMERACIL/OTERACIL
Generic name Tegafur/gimeracil/oteracil
Trade name Teysuno
Drug action Tegafur is converted after absorption into the antimetabolite 5-fluorouracil (5-FU),
gimeracil prevents degradation of 5-FU and oteracil decreases the activity of 5-FU in
normal GI mucosa.
Specific
information
Cytochrome P450 CYP2A6 is the major enzyme responsible for the conversion of
tegafur to 5-fluorouracil; therefore, co-administration of CYP2A6 inhibitors should
be avoided.
Methods of
administration
Oral. Capsules should be swallowed whole 1 hr before or 1 hr after a meal. For
patients with swallowing difficulties, try commercial jelly products.
Side effects Immediate Short-term Long-term
Very common None selected*
BMD 1 2 3 , diarrhoea 12,
nausea and vomiting 10,
constipation 11, asthenia
Peripheral neuropathy,
anorexia, fatigue
Common None selected* Lymphopenia, dehydration,
electrolyte imbalance
(including hypokalaemia 44,
hypomagnesaemia 42 ),
insomnia, dizziness,
headache 34,
hypotension 54, DVT,
dyspnoea 26, epistaxis 4 ,
hiccups, cough 26, GI
haemorrhage, stomatitis 6 ,
GI inflammation, flatulence,
abdominal pain/discomfort,
dysphagia, dyspepsia 9 , dry
mouth, mucositis,
dysgeusia 7
Dysgeusia 7 , eye
disorders 38, hearing
impairment 35,
hypertension 54, abnormal
LFTs 24, increased
creatinine, renal
impairment 30, PPE 20,
rash 19, skin
hyperpigmentation 16, dry
skin, pruritus 21,
alopecia 23, weight loss 8 ,
fever, chills
Uncommon Hypersensitivity Infections (including
neutropenic sepsis) 5 ,
altered coagulation,
hyperglycaemia, increased
LDH, hypophosphataemia,
CVA 25, pulmonary
embolism, GI perforation,
multi-organ failure
None selected*
Rare None selected*
Acute hepatic failure 24,
acute pancreatitis,
rhabdomyolysis,
Stevens-Johnson
syndrome/TEN 22,
disseminated intravascular
coagulation
ILD 26, loss of sense of
smell, nail disorders 15,
leukoencephalopathy,
photosensitivity 37
Very rare None selected* None selected* None selected*
Unknown None selected* None selected* None selected*
Nursing implications ( 1
2
3
etc) see pages 20-29. *None selected for the purposes of this handbook
February 2014
132
TEMOZOLOMIDE
Generic name Temozolomide
Trade name Temodal
Drug action Alkylating agent.
Specific
information
If temozolomide is given for 42 days continuously, prophylaxis for Pneumocystis
jiroveci pneumonia should be given. Observe closely for signs of P. jiroveci
pneumonia in patients taking concomitant steroids (regardless of the duration of
temozolomide treatment).
Temozolomide is genotoxic. Men must avoid fathering children during and for
6 months after treatment, and women must use contraception.
Methods of
administration
Oral. Tablets should be swallowed whole on an empty stomach.
Side effects Immediate Short-term Long-term
Very common None selected*
Nausea and vomiting 10,
constipation 11,
diarrhoea 12, alopecia 23,
rash 19, dry skin,
pruritus 21, erythema
None selected*
Common None selected* Oral candidiasis, dysphagia,
stomatitis 6 , anorexia 8 ,
hyperglycaemia 39,
dysgeusia 7 , cough,
dyspnoea 26,
musculoskeletal pain 34,
myasthenia, fatigue 53,
urinary incontinence,
oedema, DVT, blurred
vision 38, hearing
impairment, tinnitus 35,
anxiety 33, depression 33,
insomnia 33, headache 34,
seizures, dizziness
Thrombocytopenia 3 ,
leucopenia 2 , abnormal
LFTs 24
Uncommon None selected* None selected*
Infertility in men 27,
anaemia 1
Rare None selected* None selected* None selected*
Very rare None selected* None selected* None selected*
Unknown None selected* None selected* None selected*
Nursing implications ( 1
2
3
etc) see pages 20-29. *None selected for the purposes of this handbook
Lilly Handbook of Systemic Treatments for Cancer 8th Edition
133
TEMSIROLIMUS
Generic name Temsirolimus
Trade name Torisel
Drug action mTOR (mammalian target of rapamycin) protein kinase inhibitor.
Specific
information
Patients should be premedicated with an antihistamine 30 mins prior
to infusion. Temsirolimus contains ethanol; may be harmful to patients with
alcoholism and impair ability to drive or use machinery (especially doses higher
than 175mg).
Methods of
administration
IV infusion in 250ml NS, over 30-60 mins.
Must be administered in a non-PVC container using a non-PVC administration set
with a 0.2-5 micron filter.
The solution should be protected from excessive room light and sunlight.
Side effects Immediate Short-term Long-term
Very common
Dyspnoea 26 Nausea and vomiting 10,
diarrhoea 12, stomatitis 6 ,
rash 19, pruritus 21,
headache 34
BMD 1 2 3 ,
hypercholesterolaemia 46,
hyperlipidaemia 46,
hyperglycaemia 39, asthenia,
acne, nail disorders 15,
infections (including
cellulitis, herpes zoster,
herpes simplex), anorexia 8 ,
insomnia, increased
creatinine, pneumonia,
hypokalaemia 44,
dysgeusia 7 , fatigue 53,
oedema
Common
Hypersensitivity 52 None selected* Diabetes, increased ALT and
AST, dehydration,
hypocalcaemia 41,
hypophosphataemia 46,
renal impairment 30
Uncommon None selected* None selected* None selected*
Rare None selected* Pneumocystis jiroveci
pneumonia
None selected*
Very rare None selected* None selected* None selected*
Unknown None selected* None selected* None selected*
Nursing implications ( 1
2
3
etc) see pages 20-29. *None selected for the purposes of this handbook
February 2014
134
THALIDOMIDE
Generic name Thalidomide
Trade name Thalidomide Celgene
Drug action Immunodulator and angiogenesis inhibitor.
Specific
information
Thalidomide causes severe and life-threatening birth defects. Both female
and male patients must be enrolled in the Thalidomide Celgene Pregnancy
Prevention Programme, and a Prescription Authorisation Form must be
completed with every prescription.
Methods of
administration
Oral. Capsules should be swallowed whole as a single dose at bedtime, with or
without food.
Capsules may be opened and the contents mixed with water to give via a
nasogastric tube, or sprinkled in apple sauce, yoghurt or ice cream. Safe handling
precautions must be used when handling the capsules.
Ref: NEWT Guidelines
Side effects Immediate Short-term Long-term
Very common None selected*
Constipation 11 BMD 1 2 3 , neurological
effects (including peripheral
neuropathy 32 ),
somnolence, fatigue 53,
peripheral oedema
Common None selected*
Vomiting 10, dry mouth,
dyspnoea 26
Confusion, depression, DVT,
pulmonary embolism, ILD,
cardiac disorders 25, severe
rash 19
Uncommon None selected* None selected* None selected*
Rare None selected* None selected* None selected*
Very rare None selected* None selected* None selected*
Unknown None selected* None selected* None selected*
Nursing implications ( 1
2
3
etc) see pages 20-29. *None selected for the purposes of this handbook
Lilly Handbook of Systemic Treatments for Cancer 8th Edition
135
THIOTEPA
Generic name Thiotepa
Trade name Tepadina
Drug action Alkylating agent.
Specific
information
IRRITANT.
Methods of
administration
Reconstitute each vial with 10ml WFI, then add to 500ml NS. Administer by IV
infusion via CVAD over 2-4 hrs. If dose higher than 500mg, use 1L NS. For doses
lower than 250mg (eg, in children) use appropriate volume of NS to give final
thiotepa concentration 0.5-1mg/ml.
Side effects Immediate Short-term Long-term
Very common None selected* GvHD, GI disturbances
(nausea and vomiting 10,
diarrhoea 12, dyspepsia 9 ,
enteritis, colitis, abdominal
pain, oesophagitis 6 ,
stomatitis 6 , anorexia 8 ,
hyperglycaemia 39, rash,
pruritus 21, alopecia 23,
blurred vision 38,
conjunctivitis 38,
ototoxicity 35, CNS disorders
(convulsion, encephalopathy,
paraesthesia, dizziness,
headache) 33, arrhythmia 25,
haemorrhagic cystitis 29,
BMD 1 2 3 , infections,
amenorrhoea 27,
azoospermia 27, vaginal
haemorrhage,
lymphoedema,
hypertension 54, idiopathic
pneumonia syndrome,
epistaxis, back pain,
musculoskeletal pain 34
None selected*
Common None selected*
Hypersensitivity 52,
cataracts, intracranial
aneurysm, cerebral
haemorrhage,
tachycardia 25, renal
impairment 30, multi-organ
failure
Secondary malignancy,
hypopituitarism, cardiac
failure 25, haemorrhage 4 ,
embolism, pulmonary
oedema 26, pneumonitis 26,
hepatic disorders
(veno-occlusive liver disease,
hepatomegaly, jaundice,
abnormal LFTs) 24
Uncommon None selected* None selected* None selected*
Rare None selected* None selected* None selected*
Very rare None selected* None selected* None selected*
Unknown None selected*
Fatigue, asthenia 53 None selected*
Nursing implications ( 1
2
3
etc) see pages 20-29. *None selected for the purposes of this handbook
February 2014
136
TIOGUANINE
Generic name Tioguanine, 6-tioguanine
Trade name N/A
Drug action Antimetabolite.
Specific
information
Unlicensed liquid formulation and 10mg capsules are also available.
Methods of
administration
Oral. Tablets should be taken on an empty stomach.
Side effects Immediate Short-term Long-term
Very common None selected*
Stomatitis 6 , GI intolerance,
nausea 10, diarrhoea 12
BMD 1 2 3 , hepatic
toxicity (including
veno-occlusive disease,
portal hypertension) 24
Common None selected* None selected* None selected*
Uncommon None selected* None selected* None selected*
Rare None selected* None selected* Intestinal necrosis/
perforation
Very rare None selected* None selected* None selected*
Unknown None selected* None selected* None selected*
Nursing implications ( 1
2
3
etc) see pages 20-29. *None selected for the purposes of this handbook
Lilly Handbook of Systemic Treatments for Cancer 8th Edition
137
TOPOTECAN
Generic name Topotecan
Trade name Hycamtin
Drug action Topoisomerase I inhibitor.
Specific
information
Neutropenic colitis should be considered in patients presenting with fever,
neutropenia, and a compatible pattern of abdominal pain.
There have been reports of ILD, some of which have been fatal. Underlying risk
factors include history of ILD, pulmonary fibrosis, lung cancer, thoracic exposure to
radiation and use of pneumotoxic drugs and/or colony stimulating factors. Monitor
for symptoms of ILD and discontinue topotecan if ILD is confirmed.
Topotecan is a substrate of P-gp and BCRP; therefore, caution and careful
monitoring is advised when co-administering with drugs that inhibit P-gp or BCRP.
Methods of
administration
EXFOLIANT.
Oral, capsules.
IV infusion in NS/D5W to a concentration of 25-50 microgram/ml over 30 mins.
Side effects Immediate Short-term Long-term
Very common None selected*
Alopecia 23, fatigue 53,
asthenia, nausea and
vomiting 10, diarrhoea 12,
constipation 11,
mucositis 6 , abdominal
pain, anorexia 8
BMD 1 2 3 , infections
Common
Hypersensitivity 52,
fever, pruritus 21
Malaise
Sepsis 5 ,
hyperbilirubinaemia 24
Uncommon None selected* None selected* None selected*
Rare
Anaphylaxis 52 None selected* ILD
Very rare None selected* None selected* None selected*
Unknown None selected* None selected* Severe haemorrhage
(associated with
thrombocytopenia)
Nursing implications ( 1
2
3
etc) see pages 20-29. *None selected for the purposes of this handbook
February 2014
138
TRABECTEDIN
Generic name Trabectedin
Trade name Yondelis
Drug action Cell-cycle inhibitor. Binds to the minor groove of DNA, bending the helix to the major
groove.
Specific
information
Anti-emetic prophylaxis with corticosteroids (eg, dexamethasone) must be
administered to all patients. The dexamethasone additionally has a hepatoprotective
effect.
Trabectedin must not be used in patients with CPK > 2.5 x ULN. Rhabdomyolysis has
been uncommonly reported, usually in association with myelotoxicity, severe LFT
abnormalities and/or renal or multiorgan failure.
Caution should be taken if drugs associated with hepatotoxicity are administered
concomitantly with trabectedin. Alcohol should be avoided during treatment.
Concomitant use of trabectedin with phenytoin may reduce phenytoin absorption
and therefore is not recommended.
Co-administration of trabectedin with potent inhibitors of cytochrome P450 CYP3A4
should be avoided. If this is not possible, close monitoring of toxicities are required
and dose reduction of trabectedin should be considered.
Co-administration of trabectedin with inhibitors of P-gp, eg, verapamil or
ciclosporin, is cautioned.
Methods of
administration
VESICANT AVOID EXTRAVASATION.
Diluted with D5W and given via CVAD.
Soft tissue sarcoma: IV infusion (via an ambulatory pump as an outpatient) over
24 hrs every 3 weeks.
Ovarian cancer: 3-hr IV infusion every 3 weeks.
Side effects Immediate Short-term Long-term
Very common None selected*
Fatigue 53, asthenia 53,
nausea and vomiting 10,
constipation 11,
headache 34, anorexia 8
Increased CPK and
creatinine, decreased blood
albumin, BMD 1 2 3 ,
increased LFTs 24
Common Fever, oedema,
injection site
reactions 14
Dizziness, paraesthesia,
cough, dyspnoea 26,
dehydration, hypotension 54,
flushing 18, diarrhoea 12,
abdominal pain,
dyspepsia 9 , stomatitis 6 ,
weight loss, hypokalaemia 44
Peripheral neuropathy 32,
dysgeusia 7 , alopecia 23,
musculoskeletal pain 34,
infections 5 , insomnia
Uncommon None selected* None selected* None selected*
Rare None selected* None selected* None selected*
Very rare None selected* None selected* None selected*
Unknown None selected* None selected* None selected*
Nursing implications ( 1
2
3
etc) see pages 20-29. *None selected for the purposes of this handbook
Lilly Handbook of Systemic Treatments for Cancer 8th Edition
139
TRASTUZUMAB
Generic name Trastuzumab
Trade name Herceptin
Drug action Monoclonal antibody specific for EGFR 2 (HER2).
Specific
information
Patients should be observed for 6 hrs after the start of the first dose and for 2 hrs
after the start of subsequent doses owing to the risk of hypersensitivity.
IV infusion: if a maintenance dose is delayed by more than 1 week, the patient must
be re-loaded.
Methods of
administration
IV infusion in 250ml NS (150mg powder formulation only). Loading/reloading: infuse
over 90 mins. Maintenance: infuse over 30 mins.
SC injection (600mg/5ml solution formulation only). No loading dose required.
Administer over 2-5 mins. Injection site should be alternated between the left and
right thigh. New injections should be given at least 2.5cm from the previous site and
never into areas that are tender, bruised, red or hardened.
Side effects Immediate Short-term Long-term
Very common Injection site
reactions 14,
infusion-related
reactions,
hypersensitivity/
anaphylaxis 52, fever,
BP changes,
arrhythmia 25,
palpitation, wheezing/
dyspnoea, muscle
tightness, tremor,
erythema, rash 19,
pruritus 21, dizziness,
headache 34,
angioedema
Nausea and vomiting 10,
diarrhoea 12, asthenia 53,
fatigue 53, musculoskeletal
pain 34
Reduced LVEF 25
Common None selected*
Constipation 11 Infections 5 , BMD 1 2 3 ,
neutropenic sepsis 5 , CHF
25, cardiomyopathy 25,
oedema, hepatic impairment
24, renal disorders 30,
peripheral neuropathy 32,
paraesthesia, hypertonia,
ataxia, alopecia 23, weight
loss
Uncommon None selected* None selected* None selected*
Rare None selected* None selected* None selected*
Very rare None selected* None selected* None selected*
Unknown Respiratory distress/
failure
Renal impairment 30 None selected*
Nursing implications ( 1
2
3
etc) see pages 20-29. *None selected for the purposes of this handbook
February 2014
140
TRASTUZUMAB EMTANSINE
Generic name Trastuzumab emtansine, TDM-1, ado-trastuzumab emtansine
Trade name Kadcyla
Drug action Antibody-drug conjugate of trastuzumab (human monoclonal antibody specific for
EGFR 2/HER2) and emtansine (inhibitor of mitosis).
Specific
information
Do not substitute trastuzumab emtansine for trastuzumab (Herceptin).
Emtansine is metabolised by hepatic cytochrome P450 enzymes CYP3A4 and (to a
lesser extent) CYP3A5. Drugs that are inhibitors or inducers of these enzymes may
interact with trastuzumab emtansine.
Patients should be observed for 3 hrs after the start of the first infusion and for 1 hr
after the start of subsequent infusions owing to the risk of hypersensitivity.
Evaluation of cardiac function, including baseline LVEF, should be conducted prior to
initiation of treatment and regularly throughout treatment.
Methods of
administration
IV infusion in NS via 0.22 micron in-line non-protein adsorptive filter. Do not shake.
Give first infusion over 90 mins. If first infusion tolerated, give subsequent infusions
over 30 mins.
Side effects Immediate Short-term Long-term
Very common None selected*
Diarrhoea 12, fatigue 53,
nausea and vomiting 10,
musculoskeletal pain,
headache 34, constipation 11
Increased transaminases 24,
thrombocytopenia 3 ,
anaemia 1
Common None selected*
Mucositis 6 Hypokalaemia 44,
neutropenia 2 , PPE 20,
reduced LVEF 25, pulmonary
toxicity (ILD,
pneumonitis) 26, peripheral
neuropathy 32
Uncommon Hypersensitivity/
anaphylaxis 52
None selected* None selected*
Rare None selected* None selected* None selected*
Very rare None selected* None selected* None selected*
Unknown None selected* None selected* None selected*
Nursing implications ( 1
2
3
etc) see pages 20-29. *None selected for the purposes of this handbook
Lilly Handbook of Systemic Treatments for Cancer 8th Edition
141
TREOSULFAN
Generic name Treosulfan
Trade name N/A
Drug action Alkylating agent.
Specific
information
N/A
Methods of
administration
VESICANT AVOID EXTRAVASATION.
Oral.
IP.
IV bolus (max dose 3g/m
2
).
IV infusion (doses >3g/m
2
) at a rate of 3g/m
2
every 5-10 mins.
Doses of 8g/m
2
over 30 mins.
Side effects Immediate Short-term Long-term
Very common None selected*
Nausea and vomiting 10 BMD 1 2 3 , alopecia 23,
bronze skin pigmentation 16
Common None selected* None selected* None selected*
Uncommon None selected* None selected* Treatment-related secondary
malignancy
Rare None selected* None selected* None selected*
Very rare None selected* None selected* None selected*
Unknown
Hypersensitivity 52 Hypoglycaemia 39,
haemorrhagic cystitis 29
None selected*
Nursing implications ( 1
2
3
etc) see pages 20-29. *None selected for the purposes of this handbook
February 2014
142
TRETINOIN
Generic name Tretinoin, all-trans retinoic acid (ATRA)
Trade name Vesanoid
Drug action Not completely understood. Induces cellular differentiation and decreases the
proliferation of acute promyelocytic leukemia cells.
Specific
information
Avoid supplements containing vitamin A because of the potential for additive toxicity.
Tretinoin causes serious birth defects when taken during pregnancy.
Avoid pregnancy during treatment and for 1 month after cessation of treatment.
Pregnancy tests must be performed at monthly intervals during treatment.
The progesterone-only contraceptive (mini pill) is an inadequate form of
contraception for patients taking tretinoin, and alternative methods should be used.
Potentially fatal differentiation syndrome can occur, which is characterised by fever,
dyspnoea, weight gain, lung infiltrates, pleural or pericardial effusions and
leucocytosis. This requires immediate treatment with high-dose steroids
(eg, dexamethasone 10mg IV twice daily).
Patients must not be treated with tetracyclines and tretinoin at the same time owing
to the risk of increased intracranial pressure.
Methods of
administration
Oral, in 2 divided doses. Capsules should be swallowed whole with or just after
a meal.
Side effects Immediate Short-term Long-term
Very common None selected* Differentiation syndrome
(see Specific information),
anorexia 8 , headache 34,
confusion, anxiety,
depression, insomnia 33,
paraesthesia, visual
disturbances 38,
conjunctivitis 38, malaise,
increased serum creatinine,
flushing 18, erythema,
pruritus 21, nausea and
vomiting 10, diarrhoea 12,
constipation 11, alopecia 23,
pain (bone, chest and
abdominal) 34
Hearing impairment 35,
arrhythmia 25, pancreatitis
Common None selected* None selected* None selected*
Uncommon None selected* None selected* None selected*
Rare None selected* None selected* None selected*
Very rare None selected* None selected* None selected*
Unknown None selected* None selected*
Abnormal LFTs 24,
thrombosis,
hypercalcaemia 41, CVA, MI
Nursing implications ( 1
2
3
etc) see pages 20-29. *None selected for the purposes of this handbook
V
Guide to frequency of side effects
Very common (1/10)
Common (1/100 to <1/10)
Uncommon (1/1000 to <1/100)
Rare (1/10,000 to <1/1,000)
Very rare (<1/10,000)
Unknown (cannot be estimated from the available data spontaneous reports)
Some (but not all) of the adverse events experienced with the drugs over time are listed
in the monographs. Please consult individual SPCs for full details.
Lilly Handbook of Systemic Treatments for Cancer 8th Edition
143
VANDETANIB
Generic name Vandetanib
Trade name Caprelsa
Drug action Potent inhibitor of VEGF receptor 2, EGFR and RET tyrosine kinases and
sub-micromolar inhibitor of VEGF receptor 3.
Specific
information
Vandetanib is associated with a substantial and concentration-dependent
QT prolongation. ECG monitoring should be carried out before treatment, 1, 3, 6 and
12 weeks after starting treatment and following dose adjustment or interruption,
then every 3 months for at least 1 year. Administration of vandetanib with
substances known to cause QT prolongation is contraindicated or not recommended.
Patients without RET mutations may have a decreased benefit from vandetanib
treatment and thus a different benefit/risk balance.
The concomitant use of vandetanib with strong cytochrome P450 CYP3A4 inducers
should be avoided.
Methods of
administration
Oral. Tablets should be taken with or without food. For patients who have difficulty
swallowing, tablets may be dropped in half a glass of non-carbonated water, without
crushing, stirred until dispersed (approximately 10 mins) and the resultant
dispersion swallowed immediately. Any residues in the glass are to be mixed with
half a glass of water and swallowed. The liquid can also be administered through
nasogastric or gastrostomy tubes.
Side effects Immediate Short-term Long-term
Very common None selected*
QT prolongation 25,
GI disturbances,
photosensitivity 37, skin
reactions, nail disorders 15,
upper RTI 26, anorexia 8 ,
hypocalcaemia 41,
headache 34, paraesthesia,
dysaesthesia, dizziness,
hypertension 54, asthenia,
fatigue 53, pain, oedema,
proteinuria
Insomnia, depression 33,
UTI, visual impairment 38,
corneal structural
change 38, renal
impairment 30,
nephrolithiasis
Common None selected* Anxiety, electrolyte
disturbances,
hyperglycaemia 39,
dehydration, colitis, dry
mouth, dry eye 38,
stomatitis 6 , dysphagia,
constipation, PPE 20,
hypothyroidism, increased
AST and ALT 24, weight loss 8 ,
increased blood creatinine
Conjunctivitis 38,
alopecia 23, fever, dysuria,
haematuria, infections 5 ,
GI haemorrhage,
pyelonephritis, gastritis,
epistaxis 4 , haemoptysis,
pneumonitis, lethargy,
dysgeusia 7
Uncommon None selected* None selected* Seizures, clonus, cataract,
heart failure, arrhythmia 25,
ILD 26, pancreatitis,
peritonitis, ileus, intestinal
perforation, anuria, impaired
healing
Rare None selected* None selected* None selected*
Very rare None selected* None selected* None selected*
Unknown None selected* None selected* None selected*
Nursing implications ( 1
2
3
etc) see pages 20-29. *None selected for the purposes of this handbook
February 2014
144
VEMURAFENIB
Generic name Vemurafenib
Trade name Zelboraf
Drug action Selective inhibitor of the activated form of BRAF kinase commonly found in
metastatic melanoma.
Specific
information
Before taking vemurafenib, patients must have BRAF V600 mutation-positive
tumour status confirmed by a validated test.
Methods of
administration
Oral. Tablets must be swallowed whole, with or without food, but consistent intake of
both daily doses on an empty stomach should be avoided.
Side effects Immediate Short-term Long-term
Very common None selected*
Anorexia 8 , headache 34,
dysgeusia 7 , cough 26,
diarrhoea 12, nausea and
vomiting 10, constipation 11,
photosensitivity 37, actinic
keratosis, rash 19,
pruritus 21, hyperkeratosis,
erythema, alopecia 23, dry
skin, sunburn, fatigue 53,
fever, increased GGT
Pain in extremity,
musculoskeletal pain 34,
skin papilloma, peripheral
oedema, asthenia, cutaneous
squamous cell carcinoma
Common None selected* 7th nerve paralysis,
dizziness, folliculitis, uveitis,
PPE 20, erythema nodosum,
increased ALT, ALP and
bilirubin 24, weight loss 8 ,
QT prolongation 25
Basal cell carcinoma,
arthritis, keratosis pilaris
Uncommon None selected* Increased AST Non-cutaneous squamous
cell carcinoma, peripheral
neuropathy, retinal vein
occlusion, vasculitis,
Stevens-Johnson syndrome/
TEN 22
Rare None selected* None selected* None selected*
Very rare None selected* None selected* None selected*
Unknown None selected* None selected* None selected*
Nursing implications ( 1
2
3
etc) see pages 20-29. *None selected for the purposes of this handbook
Lilly Handbook of Systemic Treatments for Cancer 8th Edition
145
VINBLASTINE
Generic name Vinblastine
Trade name N/A
Drug action Vinca alkaloid, inhibitor of mitosis.
Specific
information
Dosage increase may be continued until the dose which reduces WBC to
approximately 3000 cells/mm
3
is reached, but must not exceed 18.5mg/m
2
for adults
or 12.5 mg/m
2
for children.
Methods of
administration
IV USE ONLY. FATAL IF GIVEN BY OTHER ROUTES.
VESICANT AVOID EXTRAVASATION.
NPSA recommendation:
Adult IV infusion in 50ml NS. Paediatric IV bolus in 20ml NS.
Note that this differs to the SPC which recommends IV bolus.
Side effects Immediate Short-term Long-term
Very common None selected* None selected* None selected*
Common None selected* None selected* None selected*
Uncommon None selected* None selected*
Hypoaesthesia 32,
paraesthesia 32, peripheral
neuritis 32, loss of deep
tendon reflexes 32
Rare None selected* None selected* None selected*
Very rare None selected* None selected* None selected*
Unknown Cold sensation/ache
along vein during
injection 14
Tumour pain 48, nausea and
vomiting 10, vesiculation of
the mouth and skin,
diarrhoea 12, anorexia 8 ,
abdominal pain, pharyngitis,
GI haemorrhage,
headache 34, seizures,
asthenia, dizziness 33
Leucopenia 2 ,
constipation 11, jaw pain 49,
depression, malaise,
alopecia 23,
amenorrhoea 27,
azoospermia 27
Nursing implications ( 1
2
3
etc) see pages 20-29. *None selected for the purposes of this handbook
February 2014
146
VINCRISTINE
Generic name Vincristine
Trade name N/A
Drug action Vinca alkaloid, inhibitor of mitosis.
Specific
information
Maximum weekly dose of 2mg for adults.
In general, adverse reactions are reversible and are related to dosage size
and cumulative dosage. The use of small amounts of vincristine daily for long
periods is not advised.
Methods of
administration
IV USE ONLY. FATAL IF GIVEN BY ANY OTHER ROUTES.
VESICANT AVOID EXTRAVASATION.
NPSA recommendation:
Adult IV infusion in 50ml NS. Paediatric IV bolus in 20ml NS.
Note that this differs from the SPC which recommends IV bolus.
Side effects Immediate Short-term Long-term
Very common None selected* None selected* None selected*
Common None selected* None selected* None selected*
Uncommon None selected* None selected* None selected*
Rare None selected* None selected* SIADH, damage to the 8th
cranial nerve resulting in
deafness, difficulty with
balance, dizziness,
nystagmus and vertigo 33
Very rare None selected* None selected* None selected*
Unknown Cold sensation along
vein 14, anaphylaxis 52
Jaw pain 49, nausea and
vomiting 10, diarrhoea 12,
constipation 11, abdominal
pain, stomatitis 6 ,
anorexia 8
Neurotoxicity and peripheral
neuritis 32, polyuria 30,
dysuria and urinary
retention 30, alopecia 23,
leucopenia 2
Nursing implications ( 1
2
3
etc) see pages 20-29. *None selected for the purposes of this handbook
Lilly Handbook of Systemic Treatments for Cancer 8th Edition
147
VINDESINE
Generic name Vindesine
Trade name N/A
Drug action Vinca alkaloid, inhibitor of mitosis.
Specific
information
Patients with demyelinating Charcot-Marie-Tooth disease (an inherited neuropathic
disorder) should not be given vindesine.
Methods of
administration
IV USE ONLY FATAL IF GIVEN BY OTHER ROUTES.
VESICANT AVOID EXTRAVASATION.
NPSA recommendation:
Paediatric IV bolus over 5-10 mins in 10-20ml NS.
Note that this differs to the SPC which recommends IV bolus.
To reduce the risk of thrombosis, avoid administering into extremities where blood
circulation is impaired (eg, owing to invading cancer, phlebitis, varicose veins).
Side effects Immediate Short-term Long-term
Very common Injection site reactions
(erythema, burning
pain 14, vein
discolouration 13 and
phlebitis 17
)
Nausea and vomiting 10 Stomatitis 6 , constipation
(mild to moderate) 11,
diarrhoea 12, anorexia, BMD
(nadir days 3-5) 1 2 3 ,
transiently increased
LFTs 24, hypoaesthesia and
paraesthesia 32
Common None selected*
Transient jaw pain 49,
generalised musculoskeletal
pain 34
Alopecia (mild) 23,
fatigue 53, fever
Uncommon
Dyspnoea 52,
bronchospasm 52
None selected* None selected*
Rare None selected* None selected* None selected*
Very rare None selected* None selected* None selected*
Unknown None selected* None selected* None selected*
Nursing implications ( 1
2
3
etc) see pages 20-29. *None selected for the purposes of this handbook
February 2014
148
VINFLUNINE
Generic name Vinflunine
Trade name Javlor
Drug action Vinca alkaloid, inhibitor of mitosis.
Specific
information
In order to prevent constipation, laxatives and dietary measures including oral
hydration are recommended from day 1 to day 5 or 7 after each infusion.
Concomitant use of potent inhibitors or inducers of cytochrome P450 CYP3A4 should
be avoided.
Methods of
administration
IV USE ONLY FATAL IF GIVEN BY OTHER ROUTES.
VESICANT AVOID EXTRAVASATION.
Venous access should be established for a 500ml bag of NS or D5W in the upper part
of the forearm or central venous arm. The IV infusion should be started with half of
the 500ml bag of NS or D5W at a free flowing rate to flush the vein. The vinflunine
solution should be piggy-backed to the side injection port closest to the 500ml bag
to further dilute the drug. Vinflunine should be infused over 20 mins. Patency should
be assessed frequently and extravasation precautions should be maintained
throughout the infusion. After the infusion is completed, the remaining NS or D5W
should be run at a flow rate of 300ml/hr. In order to flush the vein, administration of
vinflunine should always be followed by at least an equal volume of either NS
or D5W.
Side effects Immediate Short-term Long-term
Very common Injection site
reactions 14, fever
Asthenia/fatigue 53,
constipation 11, abdominal
pain 34, nausea and
vomiting 10, diarrhoea 12
BMD 1 2 3 ,
hyponatraemia,
stomatitis 6 , anorexia 8 ,
alopecia 23, myalgia 34,
weight loss 8
Common
Tachycardia 25,
hypersensitivity 52,
chest pain 25, chills,
pain, oedema,
hypotension/
hypertension 54,
phlebitis 17, dyspnoea,
cough 26
Insomnia, headache 34,
dizziness, syncope,
dysphagia, dyspepsia 9 ,
rash 19, pruritus 21,
hyperhidrosis
Infections, ear pain,
dehydration, neuralgia,
dysgeusia 7 , neuropathy,
vein thrombosis, ileus,
buccal disorders,
myasthenia, jaw pain 49,
pain in extremity,
musculoskeletal pain
Uncommon None selected* ARDS
Neutropenic sepsis 5 ,
gastric disorders,
oesophagitis, gingival
disorders 6 , visual
disturbances 38, tinnitus 35,
myocardial ischaemia, MI 25,
pharyngolaryngeal pain,
SIADH, dry skin, erythema,
renal impairment 30,
increased transaminases,
weight gain
Rare None selected* None selected* PRES
Very rare None selected* None selected* None selected*
Unknown None selected* None selected* Tumour pain
Nursing implications ( 1
2
3
etc) see pages 20-29. *None selected for the purposes of this handbook
Lilly Handbook of Systemic Treatments for Cancer 8th Edition
149
VINORELBINE
Generic name Vinorelbine
Trade name Navelbine
Drug action Vinca alkaloid, inhibitor of mitosis.
Specific
information
Maximum adult IV dose 60mg.
Maximum adult oral dose of 120mg or 160mg depending on the dose and
clinical unit (60mg/m
2
or 80mg/m
2
).
Methods of
administration
VESICANT AVOID EXTRAVASATION.
IV: ACCIDENTAL INTRATHECAL INJECTION IS LIKELY TO BE FATAL.
NPSA recommendation:
Adult IV infusion in 50ml NS. Paediatric IV bolus in 20ml NS.
Note that this differs to the SPC.
Flush with NS following administration.
Oral. Capsules should be swallowed whole and taken with food.
Side effects Immediate Short-term Long-term
Very common Injection site reactions
(erythema, burning
pain 14, vein
discolouration 13,
phlebitis 17
)
Nausea and vomiting 10 Stomatitis 6 , constipation
(mild to moderate) 11, BMD
(leucopenia, neutropenia and
anaemia; nadir-days
5-7) 1 2 , transiently
increased LFTs 24, alopecia
(mild) 23, peripheral
neuropathy 32
Common None selected* Diarrhoea (mild to
moderate) 12
Thrombocytopenia 3 , jaw
pain 49, fatigue 53, fever,
asthenia, pain 34
Uncommon Dyspnoea and
bronchospasm 52
None selected* None selected*
Rare None selected* None selected* None selected*
Very rare None selected* None selected* None selected*
Unknown None selected* None selected* None selected*
Nursing implications ( 1
2
3
etc) see pages 20-29. *None selected for the purposes of this handbook
February 2014
150
VISMODEGIB
Generic name Vismodegib
Trade name Erivedge
Drug action Inhibitor of the Hedgehog cell signalling pathway.
Specific
information
Owing to the risk of embryo-foetal death or severe birth defects, women taking
vismodegib must not be pregnant or become pregnant during treatment and for 24
months after the final dose. Women of childbearing potential must comply with
contraceptive measures specified by the SPC.
Vismodegib passes into semen and male patients must comply with contraceptive
measures while taking vismodegib and for 2 months after the final dose, as
specified by the SPC.
An appointed healthcare professional must educate patients so they understand and
acknowledge all the conditions of the Erivedge Pregnancy Prevention Programme.
Medicinal products that alter the pH of the upper GI tract (eg, PPIs, H
2
-receptor
antagonists, and antacids) may reduce vismodegib bioavailability.
Vismodegib is primarily metabolised by the liver. Medicinal products that inhibit or
induce P-gp or cytochrome P450 enzymes may interact with vismodegib.
Methods of
administration
Oral. Capsules must be swallowed whole, with or without food. The capsules must
not be opened, to avoid unintended exposure to patients and health care providers.
Side effects Immediate Short-term Long-term
Very common Nausea and
vomiting 10,
diarrhoea 12,
constipation 11
Anorexia 8 , dysgeusia 7 ,
weight loss 8 , fatigue 53,
pruritus 19
Alopecia 23, muscle spasm,
amenorrhoea 27, ageusia
Common
Rash 19 Increased liver enzymes 24,
dehydration, hyponatraemia,
dyspepsia 9 , abdominal
pain, pain in extremity,
musculoskeletal pain, flank
pain 34
Madarosis, abnormal hair
growth, asthenia, hypogeusia
Uncommon None selected* None selected* None selected*
Rare None selected* None selected* None selected*
Very rare None selected* None selected* None selected*
Unknown None selected* None selected* None selected*
Nursing implications ( 1
2
3
etc) see pages 20-29. *None selected for the purposes of this handbook
Lilly Handbook of Systemic Treatments for Cancer 8th Edition
151
References for drug monographs
Afatinib
Boehringer Ingelheim. Giotrif 20mg film-coated tablets SPC. Last updated 25/09/2013; accessed 17 January 2014
Available at: http://www.medicines.org.uk/emc/medicine/28353/SPC/Giotrif+20+mg+film-coated+tablets/
Boehringer Ingelheim. Giotrif 30mg film-coated tablets SPC. Last updated 25/09/2013; accessed 17 January 2014.
Available at: http://www.medicines.org.uk/emc/medicine/28354/SPC/Giotrif+30+mg+film-coated+tablets/
Boehringer Ingelheim. Giotrif 40mg film-coated tablets SPC. Last updated 25/09/2013; accessed 17 January 2014.
Available at: http://www.medicines.org.uk/emc/medicine/28355/SPC/Giotrif+40+mg+film-coated+tablets/
Boehringer Ingelheim. Giotrif 50mg film-coated tablets SPC. Last updated 25/09/2013; accessed 17 January 2014.
Available at: http://www.medicines.org.uk/emc/medicine/28356/SPC/Giotrif+50+mg+film-coated+tablets/
Aflibercept
Sanofi. Zaltrap 25mg/ml concentrates for solution for infusion SPC. Last updated on the eMC 09/07/2013; accessed
17 January 2014. Available at: http://www.medicines.org.uk/emc/medicine/27413/SPC/Zaltrap+25mg+ml+
concentrate+for+solution+for+infusion/
Aldesleukin
Novartis Pharmaceuticals UK Ltd. Proleukin SPC. Last updated on the eMC 27/11/2012; accessed 17 January 2014.
Available at: http://www.medicines.org.uk/EMC/medicine/19322/SPC/Proleukin/
Alemtuzumab
Genzyme Therapeutics. MabCampath 30mg/ml concentrate for solution for infusion SPC. Last updated 23/05/2011;
accessed 17 January 2014.
Arsenic trioxide
Cephalon (UK) Limited. Trisenox 1mg/ml concentrate for solution for infusion SPC. Last updated on the eMC
14/06/2013; accessed 17 January 2014. Available at: http://www.medicines.org.uk/EMC/medicine/17692/SPC/
Trisenox+1+mg+ml+concentrate+for+solution+for+infusion/
Asparaginase
EUSA Pharma (Europe) Limited. Erwinase, 10,000 Unit/vial, lyophilisate for solution for injection SPC. Last
updated on the eMC 11/03/2011; accessed 17 January 2014. Available at: http://www.medicines.org.uk/EMC/
medicine/24346/SPC/Erwinase%2c+10%2c000+Unit+vial%2c+Lyophilisate+for+solution+for+injection/
Axitinib
Pfizer Limited. Inlyta 1mg, 3mg, 5mg & 7mg film-coated tablets SPC. Last updated on the eMC 05/09/2013;
accessed 17 January 2014. Available at: http://www.medicines.org.uk/emc/medicine/27051/SPC/Inlyta+1+mg+
3mg%2c+5+mg+%26+7mg+film-coated+tablets/
Azacitidine
Celgene Ltd. Vidaza 25mg/ml powder for suspension for injection SPC. Last updated on eMC 12/04/2013; accessed
17 January 2014. Available at: http://www.medicines.org.uk/emc/medicine/21508/SPC/Vidaza+25+mg+ml+powder+
for+suspension+for+injection/
Bendamustine
Napp Pharmaceuticals Limited. Levact 2.5mg/ml powder for concentrate for solution for infusion SPC. Last
updated on the eMC 10/08/2010; accessed 17 January 2014. Available at: http://www.medicines.org.uk/emc/
medicine/23469/SPC/Levact+2.5+mg+ml+powder+for+concentrate+for+solution+for+infusion/
Bevacizumab
Roche Products Limited. Avastin 25mg/ml concentrate for solution for infusion SPC. Last updated on the eMC
24/10/2013; accessed 17 January 2014. Available at: http://www.medicines.org.uk/EMC/medicine/15748/SPC/
Avastin+25mg+ml+concentrate+for+solution+for+infusion/
February 2014
152
Bexarotene
Eisai Ltd. Targretin capsules SPC. Last updated on the eMC 04/04/2013; accessed 17 January 2014. Available at:
http://www.medicines.org.uk/emc/medicine/26618/SPC/Targretin+Capsules/
Bleomycin
ProStrakan. Bleo-Kyowa powder for solution for injection SPC. Last updated on the eMC 17/08/2012; accessed
17 January 2014. Available at: http://www.medicines.org.uk/emc/medicine/26918/SPC/Bleo-Kyowa+Powder+for+
solution+for+injection/
Bortezomib
Janssen-Cilag Ltd. Velcade 3.5mg powder for solution for injection SPC. Last updated on the eMC 06/08/2013;
accessed 17 January 2014. http://www.medicines.org.uk/EMC/medicine/17109/SPC/Velcade+3.5mg+powder+for+
solution+for+injection/
Bosutinib
Pfizer Limited. Bosulif 100mg and 500mg tablets SPC. Last updated on the eMC 07/06/2013; accessed 17 January
2014. Available at: http://www.medicines.org.uk/emc/medicine/27795/SPC/Bosulif+100mg+and+500mg+Tablets/
Brentuximab vedotin
Takeda UK Ltd. Adcetris 50mg powder for concentrate for solution for infusion SPC. Last updated on the eMC
10/12/2013; accessed 17 January 2014. Available at: http://www.medicines.org.uk/emc/medicine/27173/SPC/
Adcetris+50+mg+powder+for+concentrate+for+solution+for+infusion/
Busulfan
Pierre Fabre Limited. Busilvex 6 mg/ml concentrate for solution for infusion SPC. Last updated on the eMC
05/12/2012; accessed 17 January 2014. Available at: http://www.medicines.org.uk/EMC/medicine/12967/SPC/
Busilvex+6+mg+ml+concentrate+for+solution+for+infusion/Aspen.
Busulfan 2mg tablets SPC. Last updated on the eMC 14/05/2013; accessed 17 January 2014. Available at: http://
www.medicines.org.uk/EMC/medicine/24686/SPC/Busulfan+2+mg+tablets/
Cabazitaxel
Sanofi. Jevtana SPC. Last updated on the eMC 18/06/2013; accessed 17 January 2014. Available at: http://www.
medicines.org.uk/emc/medicine/24431/SPC/Jevtana/
Capecitabine
Roche Products Limited. Xeloda 150mg and 500mg film-coated tablets SPC. Last updated on the eMC
01/07/2013; accessed 17 January 2014. Available at: http://www.medicines.org.uk/EMC/medicine/4619/SPC/
Xeloda+150mg+and+500mg+Film-coated+Tablets/
Smyth JA, ed. The NEWT guidelines for administration of medication to patients with enteral feeding tubes or
swallowing difficulties (2nd ed). North East Wales NHS Trust, 2010. Capecitabine (p70).
Carboplatin
Hospira UK Ltd. Carboplatin 10mg/ml intravenous infusion SPC. Last updated on the eMC 09/06/2009; accessed
17 January 2014. Available at: http://www.medicines.org.uk/EMC/medicine/622/SPC/Carboplatin+10+mg+ml++
Intravenous+Infusion/
Cetuximab
Merck Serono. Erbitux 5mg/ml solution for infusion SPC. Last updated on the eMC 21/03/2013; accessed
17 January 2014. Available at: http://www.medicines.org.uk/EMC/medicine/19595/SPC/Erbitux+5mg+ml+solution+
for+infusion/
Chlorambucil
Aspen. Chlorambucil 2mg tablets SPC. Last updated on the eMC 13/02/2013; accessed 17 January 2014. Available
at: http://www.medicines.org.uk/EMC/medicine/24689/SPC/Chlorambucil+2mg+Tablets/
Lilly Handbook of Systemic Treatments for Cancer 8th Edition
153
Cisplatin
Hospira UK Ltd. Cisplatin 1mg/ml sterile concentrate SPC. Last updated on the eMC 30/04/2013; accessed
17 January 2014. Available at: http://www.medicines.org.uk/EMC/medicine/623/SPC/Cisplatin+1+mg+ml+Sterile+
Concentrate/
Cladribine
Janssen-Cilag Ltd. Leustat Injection SPC. Last updated on the eMC 25/07/2013; accessed 17 January 2014.
Available at: http://www.medicines.org.uk/EMC/medicine/6737/SPC/Leustat++Injection./
LIPOMED GmbH. Litak 2mg/ml solution for injection SPC. Last updated on the eMC 16/06/2010; accessed
17 January 2014. Available at: http://www.medicines.org.uk/EMC/medicine/20597/SPC/LITAK+2mg+ml+solution+
for+injection/
Clofarabine
Sanofi. Evoltra 1mg/ml concentrate for solution for infusion SPC. Last updated on the eMC 03/12/2013; accessed
17 January 2014. Available at: http://www.medicines.org.uk/emc/medicine/18023/SPC/Evoltra+1mg+ml+
concentrate+for+solution+for+infusion/
Crizotinib
Pfizer Limited. Xalkori 200mg and 250mg hard capsule SPC. Last updated on the eMC 03/12/2013; accessed
17 January 2014. Available at: http://www.medicines.org.uk/emc/medicine/27168/SPC/Xalkori+200mg+and+
250mg+hard+capsule/
Cyclophosphamide
Pharmacia Limited. Cyclophosphamide 50 tablets SPC. Last updated on the eMC 26/03/2012; accessed 17 January
2014. Available at: http://www.medicines.org.uk/EMC/medicine/10550/SPC/Cyclophosphamide+50+Tablets/
Cytarabine
Napp Pharmaceuticals Limited. DepoCyte 50mg suspension for injection SPC. Last updated on the eMC
14/07/2011; accessed 17 January 2014. Available at: http://www.medicines.org.uk/emc/medicine/15047/SPC/
DepoCyte+50+mg+suspension+for+injection/
Hospira UK Ltd. Cytarabine injection solution 20mg/ml SPC. Last updated on the eMC 19/11/2010; accessed
17 January 2014. Available at: http://www.medicines.org.uk/emc/medicine/8267/SPC/Cytarabine+Injection+
Solution+20+mg+ml/
Hospira UK Ltd. Cytarabine injection solution 100mg/ml SPC. Last updated on the eMC 26/11/2010; accessed 17
January 2014. Available at: http://www.medicines.org.uk/emc/medicine/8266/SPC/Cytarabine+Injection+Solution+
100+mg+ml/
Pharmacia Limited. Cytarabine Injection Solution 100mg/ml SPC. Last updated on the eMC 01/10/2013; accessed
17 January 2014. Available at: http://www.medicines.org.uk/emc/medicine/2573/SPC/Cytarabine+100mg+ml/
Dacarbazine
medac GmbH. Dacarbazine 100mg, 200mg, 500mg, 1000mg SPC. Last updated on the eMC 1/06/2011; accessed
17 January 2014. Available at: http://www.medicines.org.uk/EMC/medicine/1088/SPC/Dacarbazine+100mg%2c+
200mg%2c+500mg%2c+1000mg/
Dactinomycin
Lundbeck Pharmaceuticals Ireland Limited. Cosmegen Lyovac 500 micrograms powder for solution for injection
SPC. Last updated 11/04/2013; accessed 17 January 2014. Available at: http://www.mhra.gov.uk/home/groups/
spcpil/documents/spcpil/con1368422299321.pdf
Dasatinib
Bristol-Myers Squibb Pharmaceutical Limited. Sprycel 20mg, 50mg, 80mg, 100mg and 140mg film coated tablets
SPC. Last updated on the eMC 10/12/13; accessed 17 January 2014. Available at: http://www.medicines.org.uk/
emc/medicine/26080/SPC/Sprycel+20mg%2c+50mg%2c+80mg%2c+100mg+and+140mg+Film+Coated+Tablets/
February 2014
154
Daunorubicin liposomal
Galen Limited. DaunoXome injection 2mg/ml concentrate for solution for infusion SPC. Last updated on the eMC
20/03/2013; accessed 17 January 2014. Available at: http://www.medicines.org.uk/emc/medicine/27507/SPC/
DaunoXome+Injection+2mg+ml+Concentrate+for+Solution+for+Infusion/
Daunorubicin non-liposomal
Zentiva. Daunorubicin 20mg powder for injection SPC. Last updated on the eMC 18/11/2013; accessed 17 January
2014. Available at: http://www.medicines.org.uk/emc/medicine/26175/SPC/Daunorubicin+20mg+Powder+for+
Injection/
Decitabine
Janssen-Cilag Ltd. Dacogen 50mg powder for concentrate for solution for infusion SPC. Last updated on eMC
07/10/2013; accessed 17 January 2014. Available at: http://www.medicines.org.uk/emc/medicine/27127/SPC/
Dacogen++50+mg+powder+for+concentrate+for+solution+for+infusion./
Docetaxel
Sanofi-Aventis. Taxotere 20mg/ml concentrate for solution for infusion SPC. Last updated on the eMC 05/07/2013;
accessed 17 January 2014. Available at: http://www.medicines.org.uk/emc/medicine/25454/SPC/Taxotere+20mg+
1ml+concentrate+for+solution+for+infusion/
Sanofi-Aventis. Taxotere 80mg/4ml concentrate for solution for infusion SPC. Last updated on the eMC 08/07/2013;
accessed 17 January 2014. Available at: http://www.medicines.org.uk/emc/medicine/25413/SPC/Taxotere+80mg+
4ml+concentrate+for+solution+for+infusion/
Sanofi-Aventis. Taxotere 160mg/8ml concentrate for solution for infusion SPC. Last updated on the eMC
05/07/2013; accessed 17 January 2014. Available at: http://www.medicines.org.uk/emc/medicine/25464/SPC/
Taxotere+160mg+8ml+concentrate+for+solution+for+infusion/
medac GmbH. Taxceus 20mg/ml concentrate for solution for infusion SPC. Last updated on the eMC 05/07/2013;
accessed 17 January 2014. Available at: http://www.medicines.org.uk/emc/medicine/24349/SPC/Taxceus+20mg+
ml+concentrate+for+solution+for+infusion/
Hospira UK Ltd. Docetaxel Hospira 10mg/ml concentrate for solution for infusion SPC. Last updated on the eMC
07/03/2011; accessed 17 January 2014. Available at: http://www.medicines.org.uk/EMC/medicine/23925/SPC/
Docetaxel+Hospira+10+mg+ml+Concentrate+for+Solution+for+Infusion/
Doxorubicin liposomal
Janssen-Cilag Ltd. Caelyx 2mg/ml concentrate for solution for infusion SPC. Last updated on the eMC 22/10/2013;
accessed 17 January 2014. Available at: http://www.medicines.org.uk/EMC/medicine/7017/SPC/Caelyx+2mg+ml+
concentrate+for+solution+for+infusion/
Cephalon (UK) Limited. Myocet SPC. Last updated on the eMC 14/06/2013; accessed 17 January 2014. Available at:
http://www.medicines.org.uk/EMC/medicine/5945/SPC/Myocet/
Doxorubicin non-liposomal
medac GmbH. Doxorubicin hydrochloride 2mg/ml solution for infusion SPC. Last updated on the eMC 06/03/2012;
accessed 17 January 2014. Available at: http://www.medicines.org.uk/EMC/medicine/24588/SPC/doxorubicin+
hydrochloride+2mg+ml+solution+for+infusion/
Epirubicin
Pharmacia Limited. Pharmorubicin SPC. Last updated on the eMC 06/11/2012; accessed 17 January 2014.
Available at: http://www.medicines.org.uk/emc/medicine/14474/SPC/PHARMORUBICIN/
Actavis UK Ltd. Epirubicin hydrochloride 2mg/ml solution for injection SPC. Last updated on the eMC 10/06/2013;
accessed 17 January 2014. Available at: http://www.medicines.org.uk/emc/medicine/23966/SPC/Epirubicin+
Hydrochloride+2mg+ml+Solution+For+Injection/
Hospira UK Ltd. Epirubicin hydrochloride 2mg/ml injection SPC. Last updated on the eMC 28/06/2013; accessed
17 January 2014. Available at: http://www.medicines.org.uk/EMC/medicine/18609/SPC/Epirubicin+Hydrochloride+
2+mg+ml+Injection/
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Eribulin
Eisai Ltd. Halaven 0.44mg/ml solution for injection SPC. Last updated on the eMC 06/08/2013; accessed 17 January
2014. Available at: http://www.medicines.org.uk/emc/medicine/24382/SPC/Halaven+0.44+mg+ml+solution+for+
injection/
Erlotinib
Roche Products Limited. Tarceva 25mg, 100mg and 150mg film-coated tablets SPC. Last updated on the eMC
25/11/2013; accessed 17 January 2014. Available at: http://www.medicines.org.uk/EMC/medicine/16781/SPC/
Tarceva+25mg%2c+100mg+and+150mg+Film-Coated+Tablets/
Estramustine
Pfizer Limited. Estracyt Capsules SPC. Last updated on the eMC 12/08/2013; accessed 17 January 2014. Available
at: http://www.medicines.org.uk/EMC/medicine/1511/SPC/Estracyt+Capsules/
Etoposide
Bristol-Myers Squibb Holdings Limited. Vepesid Soft Capsules 50mg and 100mg SPC. Last updated on the eMC
23/01/2012; accessed 17 January 2014. Available at: http://www.medicines.org.uk/EMC/medicine/7051/SPC/
Vepesid+Soft+Capsules+50+mg+and+100+mg/
medac GmbH. Eposin concentrate for solution for infusion 20mg/ml SPC. Last updated on the eMC 05/12/2011;
accessed 17 January 2014. Available at: http://www.medicines.org.uk/EMC/medicine/12973/SPC/Eposin/
Smyth JA, editor. The NEWT guidelines for administration of medication to patients with enteral feeding tubes or
swallowing difficulties (2nd ed). North East Wales NHS Trust, 2010. Etoposide (p130, p353).
Etoposide phosphate
Bristol-Myers Squibb Pharmaceuticals Limited. Etopophos 100mg powder for solution for injection SPC. Last
updated on the eMC 17/02/2012; accessed 17 January 2014. Available at: http://www.medicines.org.uk/EMC/
medicine/355/SPC/Etopophos+100mg+Powder+for+Solution+for+Injection/
Everolimus
Novartis Pharmaceuticals UK Ltd. Afinitor tablets SPC. Last updated on the eMC 02/12/2013; accessed 17 January
2014. Available at: http://www.medicines.org.uk/emc/medicine/22281/SPC/Afinitor+Tablets/
Novartis Pharmaceuticals UK Ltd. Votubia 5mg tablets SPC. Last updated on the eMC 10/12/2013; accessed
17 January 2014. Available at: http://www.medicines.org.uk/emc/medicine/25053/SPC/Votubia+5mg+Tablets/
Fludarabine
Sanofi. Fludara 50mg powder for solution for injection or infusion SPC. Last updated on the eMC 13/04/2011;
accessed 17 January 2014. Available at: http://www.medicines.org.uk/EMC/medicine/1819/SPC/Fludara+50mg+
powder+for+solution+for+injection+or+infusion/
Sanofi. Fludara oral 10mg film-coated tablet SPC. Last updated on the eMC 23/08/2011; accessed 17 January 2014.
Available at: http://www.medicines.org.uk/EMC/medicine/4240/SPC/Fludara+oral+10+mg+film-coated+tablet/
5-fluorouracil
medac GmbH. Fluorouracil injection, 25mg/ml, solution for injection SPC. Last updated on the eMC 26/02/2010;
accessed 17 January 2014. Available at: http://www.medicines.org.uk/EMC/medicine/12960/SPC/Fluorouracil+
Injection%2c+25+mg+++ml%2c+solution+for+injection/
Folinic acid
medac GmbH. Sodiofolin 50mg/ml, solution for injection SPC. Last updated on the eMC 17/10/2012; accessed
17 January 2014. Available at: http://www.medicines.org.uk/EMC/medicine/4363/SPC/Sodiofolin+50+mg+ml%2c+
solution+for+injection/
Pfizer Limited. Refolinon injection 3mg/ml SPC. Last updated on the eMC 20/08/2013; accessed 17 January 2014.
Available at: http://www.medicines.org.uk/emc/medicine/4137/SPC/Refolinon+Injection+3mg+ml/
Pfizer Limited. Refolinon tablets SPC. Last updated on the eMC 15/09/2009; accessed 17 January 2014. Available
at: http://www.medicines.org.uk/emc/medicine/5780/SPC/Refolinon+Tablets/
February 2014
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Gefitinib
AstraZeneca UK Ltd. Iressa 250mg film-coated tablets SPC. last updated on the eMC 20/08/2013;
accessed 17 January 2014. Available at: http://www.medicines.org.uk/EMC/medicine/22104/SPC/
Iressa+250mg+film-coated+tablets/
Gemcitabine
Eli Lilly and Company Ltd. Gemzar 200mg powder for solution for infusion, Gemzar 1000mg powder for solution for
infusion SPC. Last updated on the eMC 30/08/2013; accessed 17 January 2014. Available at: http://www.medicines.
org.uk/emc/medicine/596/SPC/gemzar%20200mg%20powder%20for%20solution%20for%20infusion,%20
gemzar%201000mg%20powder%20for%20solution%20for%20infusion/
Hydroxycarbamide
E. R. Squibb & Sons Limited. Hydrea 500mg hard capsules SPC. Last updated on the eMC 01/06/2012;
accessed 17 January 2014. Available at: http://www.medicines.org.uk/EMC/medicine/19081/SPC/
Hydrea+500+mg+Hard+Capsules/
Idarubicin
Pharmacia Limited. Zavedos 5mg powder for solution for injection SPC. Last updated on the eMC 06/11/2012;
accessed 17 January 2014. Available at: http://www.medicines.org.uk/EMC/medicine/15362/SPC/Zavedos+5mg+
and+10mg+Powder+for+Solution+for+Injection/
Pharmacia Limited. Zavedos 10mg capsules SPC. Last updated on the eMC 06/11/2012; accessed 17 January 2014.
Available at: http://www.medicines.org.uk/emc/medicine/27148/SPC/Zavedos+10+mg+Capsules/
Ifosfamide
Baxter Healthcare Ltd. Ifosfamide injection 1g SPC. Last updated 10/07/2012; accessed 17 January 2014.
Available at: http://www.mhra.gov.uk/home/groups/spcpil/documents/spcpil/con1362371041718.pdf
Baxter Healthcare Ltd. Ifosfamide injection 2g SPC. Last updated 10/07/2012; accessed 17 January 2014.
Available at: http://www.mhra.gov.uk/home/groups/spcpil/documents/spcpil/con1362371038547.pdf
Imatinib
Novartis Pharmaceuticals UK Ltd. Glivec tablets SPC. Last updated on the eMC 28/11/2013; accessed
17 January 2014. Available at: http://www.medicines.org.uk/EMC/medicine/15014/SPC/GLIVEC+Tablets/
Interferon alfa
Merck Sharp & Dohme Limited. IntronA 18, 30 and 60 million IU solution for injection, multidose pen SPC. Last
updated on the eMC 08/05/2013; accessed 17 January 2014. Available at: http://www.medicines.org.uk/EMC/
medicine/12194/SPC/IntronA++18%2c30+and+60+million+IU+solution+for+injection%2c+multidose++pen/
Roche Products Limited. Roferon-A 18MIU/0.6ml Cartridge SPC. Last updated on the eMC 29/07/2013;
accessed 17 January 2014. Available at: http://www.medicines.org.uk/emc/medicine/2580/SPC/
Roferon-A+18MIU+0.6ml+Cartridge/
Roche Products Limited. Roferon-A Pre-Filled Syringe SPC. Last updated on the eMC 25/07/2013;
accessed 17 January 2014. Available at: http://www.medicines.org.uk/emc/medicine/1730/SPC/
Roferon-A+Pre-Filled+Syringe/
Ipilimumab
Bristol-Myers Squibb Pharmaceuticals Limited. Yervoy 5mg/ml concentrate for solution for infusion SPC. Last
updated on the eMC 12/11/2013; accessed 17 January 2014. Available at: http://www.medicines.org.uk/emc/
medicine/24779/SPC/YERVOY+5+mg+ml+concentrate+for+solution+for+infusion/
Irinotecan
Pfizer Limited. Campto 20mg/ml concentrate for solution for infusion SPC. Last updated on the eMC 30/04/2013;
accessed 17 January 2014. Available at: http://www.medicines.org.uk/emc/medicine/12508/SPC/Campto+20mg+
ml+concentrate+for+solution+for+infusion/
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Lapatinib
GlaxoSmithKline UK. Tyverb SPC. Last updated 12/08/2013; accessed 17 January 2014. Available at:
http://www.medicines.org.uk/EMC/medicine/20929/SPC/Tyverb/
Lenalidomide
Celgene Ltd. Revlimid SPC. Last updated 06/12/2013; accessed 17 January 2013. Available at: http://www.
medicines.org.uk/emc/medicine/19841/SPC/Revlimid/
Lomustine
medac GmbH. Lomustine medac 40mg SPC. Last updated on the eMC 14/03/2013; accessed 17 January 2014.
Available at: http://www.medicines.org.uk/EMC/medicine/6252/SPC/Lomustine+%22medac%22+40+mg/
Melphalan
Aspen. Melphalan 2mg tablets SPC. Last updated on the eMC 07/02/2013; accessed 17 January 2014. Available at:
http://www.medicines.org.uk/emc/medicine/2605/SPC/Melphalan+2+mg+Tablets/
Aspen. Melphalan 50mg powder and solvent for solution for injection/infusion SPC. Last updated on the eMC
07/02/2013; accessed 17 January 2014. Available at: http://www.medicines.org.uk/emc/medicine/703/SPC/
Melphalan+50+mg+Powder+and+Solvent+for+Solution+for+Injection+Infusion/
Mercaptopurine
Aspen. Mercaptopurine 50mg tablets SPC. Last updated on the eMC 17/04/2013; accessed 17 January 2014.
Available at: http://www.medicines.org.uk/EMC/medicine/24688/SPC/PURI-NETHOL+50+mg+Tablets/
Mesna
Baxter Healthcare Ltd. Mesna tablets 400mg SPC. Last updated 06/04/2009; accessed 17 January 2014.
Baxter Healthcare Ltd. Mesna injection SPC. Last updated 06/04/2009; accessed 17 January 2014.
Joint Formulary Committee. British National Formulary (online) London: BMJ Group and Pharmaceutical Press.
Available at http://www.medicinescomplete.com (accessed 17 January 2014)
Methotrexate
Pharmacia Limited. Maxtrex tablets 10mg SPC. Last updated on the eMC 15/11/2013; accessed 17 January 2014.
Available at: http://www.medicines.org.uk/EMC/medicine/6005/SPC/Maxtrex+Tablets+10+mg/
Hospira UK Ltd. Methotrexate 100mg/ml injection SPC. Last updated on the eMC 30/01/2009; accessed 17 January
2014. Available at: http://www.medicines.org.uk/EMC/medicine/11588/SPC/Methotrexate+100+mg+ml+Injection/
Accord Healthcare Limited. Methotrexate 25mg/ml solution for injection SPC. Last updated on the eMC 12/11/2013;
accessed 17 January 2014. Available at: http://www.medicines.org.uk/emc/medicine/26959/SPC/Methotrexate+25+
mg+ml+solution+for+injection/
Mifamurtide
Takeda UK Ltd. Mepact 4mg powder for suspension for infusion SPC. Last updated on the eMC 04/10/2013;
accessed 17 January 2014. Available at: http://www.medicines.org.uk/emc/medicine/22763/SPC/Mepact+4+mg+
powder+for+suspension+for+infusion/
Mitomycin
ProStrakan. Mitomycin C SPC. Last updated on the eMC 31/05/2013; accessed 17 January 2014. Available at:
http://www.medicines.org.uk/emc/medicine/26917/SPC/Mitomycin+C/
Mitotane
HRA Pharma UK and Ireland Limited. Lysodren 500mg tablets SPC. Last updated on the eMC 04/07/2013; accessed
17 January 2014. Available at: http://www.medicines.org.uk/EMC/medicine/16347/SPC/Lysodren+500+mg+tablets/
Mitoxantrone
Hospira UK Ltd. Mitoxantrone (Mitozantrone) 2mg/ml sterile concentrate SPC. Last updated on the eMC
18/02/2013; accessed 17 January 2014. Available at: http://www.medicines.org.uk/EMC/medicine/10050/SPC/
Mitoxantrone+(Mitozantrone)+2+mg+ml+Sterile+Concentrate/
February 2014
158
Nelarabine
GlaxoSmithKline UK. Atriance 5mg/ml solution for infusion SPC. Last updated on the eMC 21/06/2013; accessed
17 January 2014. Available at: http://www.medicines.org.uk/emc/medicine/20045/SPC/Atriance+5+mg+ml+
solution+for+infusion/
Nilotinib
Novartis Pharmaceuticals UK Ltd. Tasigna 150mg hard capsules SPC. Last updated on the eMC 09/09/2013;
accessed 17 January 2014. Available at: http://www.medicines.org.uk/emc/medicine/24089/SPC/
Tasigna+150mg+Hard+Capsules/
Novartis Pharmaceuticals UK Ltd. Tasigna 200mg hard capsules SPC. Last updated on the eMC 09/09/2013;
accessed 17 January 2014. Available at: http://www.medicines.org.uk/EMC/medicine/20827/SPC/
Tasigna+200+mg+hard+capsules/
Ofatumumab
GlaxoSmithKline UK. Arzerra (acetate formulation) SPC. Last updated on the eMC 27/11/2013; accessed 17 January
2014. Available at: http://www.medicines.org.uk/emc/medicine/23022/SPC/Arzerra+%28acetate+formulation%29/
Oxaliplatin
Sanofi. Eloxatin 5mg/ml concentrate for solution for infusion SPC. Last updated on the eMC 03/02/2012; accessed
17 January 2014. Available at: http://www.medicines.org.uk/EMC/medicine/17367/SPC/Eloxatin+5+mg+ml+
concentrate+for+solution+for+infusion/
Actavis UK Ltd. Oxaliplatin 5mg/ml powder for solution for infusion SPC. Last updated on the eMC 06/01/2011;
accessed 17 January 2014. Available at: http://www.medicines.org.uk/EMC/medicine/24061/SPC/Oxaliplatin+5mg+
ml+powder+for+solution+for+infusion/
Paclitaxel albumin
Celgene Ltd. Abraxane 5mg/ml powder for suspension for infusion SPC. Last updated on the eMC 23/08/2013;
accessed 17 January 2014. Available at: http://www.medicines.org.uk/EMC/medicine/21384/SPC/Abraxane+5+mg+
ml+powder+for+suspension+for+infusion/
Paclitaxel non-albumin
Hospira UK Ltd. Paclitaxel 6mg/ml concentrate for solution for infusion SPC. Last updated on the eMC 24/08/2012;
accessed 17 January 2014. Available at: http://www.medicines.org.uk/EMC/medicine/15842/SPC/Paclitaxel+6+mg+
ml++concentrate+for+solution+for+infusion/
Actavis UK Ltd. Paclitaxel 6mg/ml concentrate for solution for infusion SPC. Last updated on the eMC 18/07/2013;
accessed 17 January 2014. Available at: http://www.medicines.org.uk/EMC/medicine/24064/SPC/Paclitaxel+6mg+
ml+Concentrate+For+Solution+For+Infusion/
Panitumumab
Amgen Ltd. Vectibix SPC. Last updated on the eMC 15/08/2013; accessed 17 January 2014.
Available at: http://www.medicines.org.uk/emc/medicine/20528/SPC/Vectibix/
Pazopanib
GlaxoSmithKline UK. Votrient 200mg and 400mg film coated tablets SPC. Last updated on the eMC 15/08/2013;
accessed 17 January 2014. Available at: http://www.medicines.org.uk/EMC/medicine/23148/SPC/Votrient+200+mg+
and+400+mg+film+coated+tablets/
Pemetrexed
Eli Lilly and Company Limited. Alimta 100mg/500mg powder for concentrate for solution for infusion SPC. Last
updated on the eMC 22/11/2012; accessed 17 January 2014. Available at: http://www.medicines.org.uk/EMC/
medicine/15513/SPC/Alimta+100mg+500mg+powder+for+concentrate+for+solution+for+infusion/
Pentostatin
Hospira UK Ltd. Nipent 10mg powder for solution for injection, powder for solution for infusion SPC. Last
updated on the eMC 24/08/2012; accessed 17 January 2014. Available at: http://www.medicines.org.uk/EMC/
medicine/20604/SPC/Nipent+10+mg+powder+for+solution+for+injection%2c+powder+for+solution+for+infusion/
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159
Pertuzumab
Roche Products Limited. Perjeta 420mg concentrate for solution for infusion SPC. Last updated on the eMC
25/09/2013; accessed 17 January 2014. Available at: http://www.medicines.org.uk/emc/medicine/27473/SPC/
Perjeta+420+mg+Concentrate+for+Solution+for+Infusion/
Pixantrone
CTI Life Sciences Limited. Pixuvri 29mg powder for concentrate for solution for infusion SPC. Last updated
14/05/2013; accessed 17 January 2014.
Pomalidomide
Celgene Ltd. Imnovid SPC. Last updated on the eMC 30/09/2013; accessed 17 January 2014. Available at:
http://www.medicines.org.uk/emc/medicine/28269/SPC/Imnovid/
Ponatinib
Ariad Pharma (UK) Ltd. Iclusig 15mg and 45mg film-coated tablets SPC. Last updated on the eMC
19/08/2013; accessed 17 January 2014. Available at: http://www.medicines.org.uk/emc/medicine/28145/SPC/
Iclusig+15mg+and+45mg+film-coated+tablets/
Procarbazine
Alliance Pharmaceuticals. Procarbazine capsules 50mg SPC. Last updated on the eMC 30/09/2013; accessed
17 January 2014. Available at: http://www.medicines.org.uk/EMC/medicine/386/SPC/
Procarbazine+Capsules+50mg/
Smyth JA, editor. The NEWT guidelines for administration of medication to patients with enteral feeding tubes or
swallowing difficulties (2nd ed). North East Wales NHS Trust, 2010. Procarbazine (p260).
Raltitrexed
Hospira UK Ltd. Tomudex SPC. Last updated on the eMC 19/08/2013; accessed 17 January 2014. Available at:
http://www.medicines.org.uk/EMC/medicine/2307/SPC/Tomudex/
Regorafenib
Bayer plc. Stivarga 40mg film-coated tablets SPC. Last updated on the eMC 30/09/2013; accessed 17/01/2014.
Available at: http://www.medicines.org.uk/emc/medicine/28270/SPC/Stivarga+40+mg+film-coated+tablets/
Rituximab
Roche Products Limited. Mabthera 100mg and 500mg concentrate for solution for infusion SPC. Last updated on
the eMC 04/12/2013; accessed 17 January 2014. Available at: http://www.medicines.org.uk/EMC/medicine/2570/
SPC/Mabthera+100mg+and+500mg+concentrate+for+solution+for+infusion/
Ruxolitinib
Novartis Pharmaceuticals UK Ltd. Jakavi 5mg, 15mg and 20mg tablets SPC. Last updated on the eMC 29/11/2013;
accessed 17 January 2014. Available at: http://www.medicines.org.uk/emc/medicine/26991/SPC/Jakavi+5mg%2c+
15mg+and+20mg+Tablets/
Sorafenib
Bayer plc. Nexavar 200mg film-coated tablets SPC. Last updated on the eMC 27/03/2013; accessed 17 January
2014. Available at: http://www.medicines.org.uk/EMC/medicine/18520/SPC/Nexavar+200mg+film-coated+tablets/
Streptozocin
Keocyt SAS. Streptozocin Zanosar patient leaflet. Last updated January 2008.
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Sunitinib
Pfizer Limited. Sutent 12.5mg, 25mg, 37.5mg and 50mg hard capsules SPC. Last updated on the eMC 03/05/2013;
accessed 17 January 2014. Available at: http://www.medicines.org.uk/emc/medicine/18531/SPC/SUTENT+12.5mg
%2c+25mg%2c+37.5mg+and+50mg+Hard+Capsules/
Tegafur/gimeracil/oteracil
Nordic Pharma Limited. Teysuno 15mg/4.35mg/11.8mg hard capsules SPC. Last updated on the eMC 01/10/2013;
accessed 17 January 2014. Available at: http://www.medicines.org.uk/emc/medicine/26160/SPC/Teysuno+15mg+
4.35mg+11.8mg+hard+capsules/
Nordic Pharma Limited. 20mg/5.8mg/15.8mg hard capsules SPC. Last updated on the eMC 01/10/2013; accessed
17 January 2014. Available at: http://www.medicines.org.uk/emc/medicine/26159/SPC/Teysuno+20mg+5.8mg+
15.8mg+hard+capsules/
Temozolomide
Merck Sharp & Dohme Limited. Temodal capsules SPC. Last updated on the eMC 31/01/2013; accessed 17 January
2014. Available at: http://www.medicines.org.uk/EMC/medicine/7027/SPC/Temodal+Capsules/
Temsirolimus
Pfizer Limited. Torisel 30mg concentrate and diluent for solution for infusion SPC. Last updated on the eMC
06/12/2013; accessed 17 January 2014. Available at: http://www.medicines.org.uk/emc/medicine/21260/SPC/
TORISEL+30+mg+concentrate+and+diluent+for+solution+for+infusion/
Thalidomide
Celgene Ltd. Thalidomide Celgene 50mg hard capsules SPC. Last updated on the eMC 01/08/2013; accessed
13/6/2011. Available at: http://www.medicines.org.uk/EMC/medicine/21005/SPC/Thalidomide+Celgene+50+mg+
Hard+Capsules
Smyth JA, editor. The NEWT guidelines for administration of medication to patients with enteral feeding tubes or
swallowing difficulties (2nd ed). North East Wales NHS Trust; 2010. Thalidomide (p299, p300).
Thiotepa
Adienne S.r.l. Tepadina 100mg powder for concentrate for solution for infusion SPC. Last updated on the eMC
26/10/2011; accessed 17 January 2014. Available at: http://www.medicines.org.uk/EMC/medicine/24249/SPC/
TEPADINA+100+mg+powder+for+concentrate+for+solution+for+infusion/
Tioguanine
Aspen. Tioguanine 40mg tablets SPC. Last updated on the eMC 12/04/2013; accessed 17 January 2014. Available
at: http://www.medicines.org.uk/EMC/medicine/24687/SPC/Tioguanine+40+mg+Tablets/
Topotecan
GlaxoSmithKline UK. Hycamtin 0.25mg and 1mg hard capsule SPC. Last updated on the eMC 02/12/2013; accessed
17 January 2014. Available at: http://www.medicines.org.uk/EMC/medicine/21246/SPC/Hycamtin+0.25mg+and+1+
mg+hard+capsule/
GlaxoSmithKline UK. Hycamtin 1mg and 4mg powder for concentrate for solution for infusion SPC. Last updated on
the eMC 02/12/2013; accessed 17 January 2014. Available at: http://www.medicines.org.uk/EMC/medicine/15277/
SPC/Hycamtin+1mg+and+4mg+powder+for+concentrate+for+solution+for+infusion/
Trabectedin
Pharma Mar, S.A. Yondelis 0.25mg powder for concentrate for solution for infusion/Yondelis 1mg powder for
concentrate for solution for infusion SPC. Last updated on eMC 06/08/2013; accessed 17 January 2014. Available
at: http://www.medicines.org.uk/emc/medicine/20457/SPC/Yondelis+0.25+mg+powder+for+concentrate+for+
solution+for+infusion+Yondelis+1+mg+powder+for+concentrate+
for+solution+for+infusion/
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Trastuzumab
Roche Products Limited. Herceptin 150mg powder for concentrate for solution for infusion SPC. Last updated on
the eMC 11/09/2013; accessed 17 January 2014. Available at: http://www.medicines.org.uk/EMC/medicine/3567/
SPC/Herceptin+150mg+Powder+for+concentrate+for+solution+for+infusion/
Roche Products Limited. Herceptin 600mg/5ml solution for injection SPC. Last updated on the eMC 04/09/2013;
accessed 17 January 2014. Available at: http://www.medicines.org.uk/emc/medicine/28179/SPC/Herceptin+600+
mg+5+ml+Solution+for+Injection/
Trastuzumab emtansine
Roche Products Limited. Kadcyla 100mg and 160mg powder for concentrate for solution for infusion SPC. Last
updated 15/11/2013; accessed 17 January 2014.
Treosulfan
medac GmbH. Treosulfan capsules 250mg (medac UK). SPC. Last updated on the eMC 11/09/2008; accessed 17
January 2014. Available at: http://www.medicines.org.uk/EMC/medicine/6426/SPC/Treosulfan+Capsules+250+mg+
++(Medac+UK)/
medac GmbH. Treosulfan injection (medac UK) SPC. Last updated on the eMC 18/09/2008; accessed 17 January
2014. Available at: http://www.medicines.org.uk/EMC/medicine/6431/SPC/Treosulfan+Injection++(medac+UK)/
Tretinoin
Intrapharm Laboratories Limited. Vesanoid 10mg soft capsules SPC. Last updated on the eMC 06/11/2013;
accessed 17 January 2014. Available at: http://www.medicines.org.uk/emc/medicine/1743/SPC/
Vesanoid+10mg+soft+capsules/
Vandetanib
AstraZeneca UK Limited. Caprelsa 100mg & 300mg film coated tablets SPC. Last updated on the eMC 22/02/2012;
accessed 17 January 2014. Available at: http://www.medicines.org.uk/emc/medicine/26040/SPC/Caprelsa+100+
mg+%26+300+mg+film+coated+tablets/
Vemurafenib
Roche Products Limited. Zelboraf 240mg film-coated tablets SPC. Last updated on the eMC 27/11/2013;
accessed 17 January 2014. Available at: http://www.medicines.org.uk/emc/medicine/26056/SPC/
Zelboraf+240+mg+Film-coated+Tablets/
Vinblastine
Hospira UK Ltd. Vinblastine sulphate 1mg/ml injection SPC. Last updated on the eMC 02/06/2009; accessed 17
January 2014. Available at: http://www.medicines.org.uk/EMC/medicine/6549/SPC/Vinblastine+Sulphate+1+mg+
ml+Injection/
National Patient Safety Agency. Using vinca alkaloid minibags (adult/adolescent units). Central Alert System (CAS)
reference NPSA/2008/RRR004. Last updated 11/08/2008; accessed 17 January 2014. Available at: http://www.nrls.
npsa.nhs.uk/resources/?EntryId45=59890
Vincristine
Hospira UK Ltd. Vincristine sulphate 1mg/ml injection SPC. Last updated on the eMC 07/05/2009; accessed
21/6/2011. Available at: http://www.medicines.org.uk/EMC/medicine/7298/SPC/Vincristine+Sulphate+1+mg+ml+
Injection/
National Patient Safety Agency. Using vinca alkaloid minibags (adult/adolescent units). Central Alert System (CAS)
reference NPSA/2008/RRR004. Last updated 11/08/2008; accessed 17 January 2014. Available at: http://www.nrls.
npsa.nhs.uk/resources/?EntryId45=59890
Vindesine
Genus Pharmaceuticals Limited. Eldisine powder for solution for injection SPC. Last updated 23/07/2008; accessed
17 January 2014.
National Patient Safety Agency. Using vinca alkaloid minibags (adult/adolescent units). Central Alert System (CAS)
reference NPSA/2008/RRR004. Last updated 11/08/2008; accessed 17 January 2014. Available at: http://www.nrls.
npsa.nhs.uk/resources/?EntryId45=59890
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162
Vinflunine
Pierre Fabre Limited. Javlor 25mg/ml concentrate for solution for infusion SPC. Last updated on the eMC
30/07/2013; accessed 17 January 2014. Available at: http://www.medicines.org.uk/emc/medicine/22762/SPC/
Javlor+25+mg+ml+concentrate+for+solution+for+infusion/
Vinorelbine
Pierre Fabre Limited. Navelbine 10mg/ml concentrate for solution for infusion SPC. Last updated on the eMC
17/08/2011; accessed 17 January 2014. Available at: http://www.medicines.org.uk/EMC/medicine/16029/SPC/
Navelbine+10+mg+++ml+concentrate+for+solution+for+infusion/
Pierre Fabre Limited. Navelbine 30mg soft capsule SPC. Last updated on the eMC 17/08/2011; accessed 17/8/2011.
Available at: http://www.medicines.org.uk/EMC/medicine/1604/SPC/Navelbine+30mg+soft+capsule/
National Patient Safety Agency. Using vinca alkaloid minibags (adult/adolescent units). Central Alert System (CAS)
reference NPSA/2008/RRR004. Last updated 11/08/2008; accessed 17 January 2014. Available at:
http://www.nrls.npsa.nhs.uk/resources/?EntryId45=59890
Vismodegib
Roche Products Limited. Erivedge 150mg hard capsules SPC. Last updated on the eMC 05/08/2013;
accessed 17 January 2014. Available at: http://www.medicines.org.uk/emc/medicine/28107/SPC/
Erivedge+150+mg+hard+capsules/
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Appendix 1
Glossary
absolute risk
A measure of the risk of a certain event happening. In cancer research, it is the likelihood that a
person who is free of a specific type of cancer at a given age will develop that cancer over a certain
period of time. For example, a woman 35 years of age, with no known risk factors for breast cancer,
has an absolute risk of getting breast cancer.
alkylating agent
A type of drug that is used in the treatment of cancer. It interferes with the cells DNA and inhibits
cancer cell growth.
angiogenesis
Blood vessel formation. Tumour angiogenesis is the growth of new blood vessels that tumours need
to grow. This process is caused by the release of chemicals by the tumour and by host cells near
the tumour.
angiogenesis inhibitor
A drug or substance that keeps new blood vessels from forming. In cancer treatment, angiogenesis
inhibitors may prevent the growth of new blood vessels that tumours need to grow.
anthracycline
A type of antibiotic that comes from certain types of Streptomyces bacteria. Anthracyclines are used
to treat many types of cancer. Anthracyclines damage the DNA in cancer cells, causing them to die.
Daunorubicin, doxorubicin and epirubicin are anthracyclines.
antibody-dependent cell-mediated cytotoxicity (ADCC)
A type of immune reaction in which a target cell or microbe is coated with antibodies and killed
by certain types of white blood cells. The white blood cells bind to the antibodies and release
substances that kill the target cells or microbes. Also called antibody-dependent cellular
cytotoxicity.
antigen
Any substance that causes the body to make a specific immune response.
antimetabolite
A drug that is very similar to natural chemicals involved in a normal biochemical reaction in cells
but different enough to interfere with the normal division and functions of cells.
antisense DNA
Small pieces of DNA that can bind to specific molecules of RNA and block the cells ability to use the
RNA to make a protein or work in other ways. Antisense DNA may be used to block the production
of proteins needed for cell growth. It is being studied in the treatment of many types of cancer.
anti-VEGFR monoclonal antibody
A monoclonal antibody being studied in the treatment of some types of cancer. Monoclonal
antibodies are made in the laboratory and can locate and bind to substances in the body, including
cancer cells. Anti-VEGFR monoclonal antibodies bind to receptors for vascular endothelial growth
factor (VEGF) and keep VEGF from binding to them. This may stop the growth of new blood vessels
that tumours need to grow. They act as antiangiogenesis agents.
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apoptosis
A type of cell death in which a series of molecular steps in a cell lead to its death. This is one
method the body uses to get rid of unneeded or abnormal cells. The process of apoptosis may be
blocked in cancer cells. Also called programmed cell death.
B cell
A type of white blood cell that makes antibodies. B cells are part of the immune system and develop
from stem cells in the bone marrow. Also called B lymphocyte.
Bcr-Abl fusion protein
A protein made from pieces of two genes that get joined together. It is found in most patients with
chronic myelogenous leukaemia, and in some patients with acute lymphoblastic leukaemia or acute
myelogenous leukaemia. Inside the leukaemia cells, the Abl gene from chromosome 9 joins to the
Bcr gene on chromosome 22 to form the Bcr-Abl fusion gene, which makes the Bcr-Abl fusion protein.
blood-brain barrier (BBB)
A network of blood vessels and tissue that is made up of closely spaced cells and helps keep
harmful substances from reaching the brain. The blood-brain barrier lets some substances, such
as water, oxygen, carbon dioxide and general anaesthetics, pass into the brain. It also keeps out
bacteria and other substances, including many anticancer drugs.
brachytherapy
A type of radiation therapy in which radioactive material sealed in needles, seeds, wires or
catheters is placed directly into or near a tumour. Also called implant radiation therapy, internal
radiation therapy and radiation brachytherapy.
bronchoscopy
A procedure that uses a bronchoscope to examine the inside of the trachea, bronchi (air passages
that lead to the lungs) and lungs. A bronchoscope is a thin, tube-like instrument with a light and
a lens for viewing. It may also have a tool to remove tissue to be checked under a microscope for
signs of disease. The bronchoscope is inserted through the nose or mouth. Bronchoscopy may be
used to detect cancer or to perform some treatment procedures.
carcinogen
Any substance that causes cancer.
carcinoma in situ
A group of abnormal cells that remain in the place where they first formed. They have not spread.
These abnormal cells may become cancer and spread into nearby normal tissue. Also called
stage 0 disease.
cell-cell signalling
The transfer of information from one cell to another. Cells signal to each other by direct contact
or by the release of a substance from one cell that is taken up by another cell. Cell-cell signalling
is important for cells to grow and work normally. Cells that lose the ability to respond to signals
from other cells may become cancer cells. Also called cell-to-cell signalling and intercellular
communication.
cell-cycle regulation
Any process that controls the series of events by which a cell goes through the cell cycle. During
the cell cycle, a cell makes a copy of its DNA and other contents, and divides in two. When cell cycle
regulation doesnt happen correctly, cells may divide in an uncontrolled way and diseases such as
cancer can occur.
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central venous access catheter
A thin, flexible tube that is inserted into a vein in the upper arm, thigh or neck or below the
collarbone. It is guided (threaded) into a large vein near the heart called the vena cava or into the
right atrium of the heart. It is used to give intravenous fluids, blood transfusions and chemotherapy
and other drugs, and for taking blood samples. It reduces the need for repeated injections.
chemoradiation
Treatment that combines chemotherapy with radiation therapy. Also called chemoradiotherapy.
DNA
The molecules inside cells that carry genetic information and pass it from one generation to the
next. Also called deoxyribonucleic acid.
DNA methyltransferase
An enzyme that attaches methyl groups to DNA. A methyl group is a chemical group containing one
carbon and three hydrogen atoms. Also called DNA methylase.
epidermal growth factor receptor (EGFR)
The protein found on the surface of some cells to which epidermal growth factor binds, causing the
cells to divide. It is found at abnormally high levels on the surface of many types of cancer cells, so
these cells may divide excessively in the presence of epidermal growth factor. Also called ErbB1
and HER1.
febrile neutropenia
A condition marked by fever and a lower-than-normal number of neutrophils in the blood. A
neutrophil is a type of white blood cell that helps fight infection. Having too few neutrophils
increases the risk of infection.
fusion gene
A gene made by joining parts of two different genes. Fusion genes may occur naturally in the body
by transfer of DNA between chromosomes. For example, the BCR-ABL gene found in some types of
leukaemia is a fusion gene. Fusion genes can also be made in the laboratory by combining genes or
parts of genes from the same or different organisms.
genomic profile
Information about all the genes in an organism, including variations, gene expression and the way
those genes interact with each other and with the environment. A genomic profile may be used to
discover why some people get certain diseases while other people do not, or why people respond
differently to the same drug.
hazard ratio
A measure of how often a particular event happens in one group compared to how often it happens
in another group, over time. In cancer research, hazard ratios are often used in clinical trials
to measure survival at any point in time in a group of patients who have been given a specific
treatment compared to a control group given another treatment or a placebo. A hazard ratio of one
means that there is no difference in survival between the two groups. A hazard ratio of greater than
one or less than one means that survival was better in one of the groups.
Karnofsky Performance Status (KPS)
A standard way of measuring the ability of cancer patients to perform ordinary tasks. The Karnofsky
Performance scores range from 0 to 100. A higher score means the patient is better able to carry
out daily activities. KPS may be used to determine a patients prognosis, to measure changes in a
patients ability to function, or to decide if a patient could be included in a clinical trial.
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mean survival
The average length of time from either the date of diagnosis or the start of treatment for a disease,
such as cancer, for which the patient is alive. In a clinical trial, measuring mean survival is one way
to see how well a new treatment works.
measurable disease
A tumour that can be accurately measured in size. This information can be used to judge response
to treatment.
meiosis
A special form of cell division in which each daughter cell receives half the amount of DNA as the
parent cell. Meiosis occurs during formation of egg and sperm cells in mammals.
metastasis
The spread of cancer from one part of the body to another. A tumour formed by cells that have
spread is called a metastatic tumour or a metastasis. The metastatic tumour contains cells that
are like those in the original (primary) tumour. The plural form of metastasis is metastases.
micrometastasis
Small numbers of cancer cells that have spread from the primary tumour to other parts of the body
and are too few to be picked up in a screening or diagnostic test.
mitosis
The process by which a single parent cell divides to make two new daughter cells. Each daughter
cell receives a complete set of chromosomes from the parent cell. This process allows the body to
grow and replace cells.
mitotic inhibitor
A type of drug that blocks cell growth by stopping mitosis (cell division). Mitotic inhibitors are used
to treat cancer. Also called antimitotic agent.
molecular marker
A biological molecule found in blood, other body fluids or tissues that is a sign of a normal or
abnormal process, or of a condition or disease. A molecular marker may be used to see how
well the body responds to a treatment for a disease or condition. Also called biomarker and
signature molecule.
monoclonal antibody
A type of protein made in the laboratory that can bind to substances in the body, including cancer
cells. There are many kinds of monoclonal antibodies. A monoclonal antibody is made so that it
binds to only one substance. Monoclonal antibodies are being used to treat some types of cancer.
They can be used alone or to carry drugs, toxins or radioactive substances directly to cancer cells.
oestrogen receptor (ER)
A protein found inside the cells of the female reproductive tissue, some other types of tissue and
some cancer cells. The hormone oestrogen will bind to the receptors inside the cells and may cause
the cells to grow.
oncogene
A mutated (changed) form of a gene involved in normal cell growth. Oncogenes may cause the
growth of cancer cells. Mutations in genes that become oncogenes can be inherited or caused by
being exposed to substances in the environment that cause cancer.
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phlebitis
Inflammation (redness, swelling, pain and heat) of a vein, usually in the legs. Phlebitis may be
caused by infection, injury or irritation.
phototoxicity
A condition in which the skin or eyes become very sensitive to sunlight or other forms of light. It can
be caused by taking certain drugs or rubbing certain essential oils (scented liquid taken from plants)
or other topical agents into the skin. Phototoxicity causes sunburn, blisters and other skin problems.
predictive factor
A condition or finding that can be used to help predict whether a persons cancer will respond
to a specific treatment. The term may also describe something that increases a persons risk of
developing a condition or disease.
progesterone receptor (PR)
A protein found inside the cells of the female reproductive tissue, some other types of tissue and
some cancer cells. The hormone progesterone binds to the receptors inside the cells and may
cause the cells to grow.
prognostic factor
A situation or condition, or a characteristic of a patient, that can be used to estimate the chance of
recovery from a disease or the chance of the disease recurring (coming back).
progression-free survival
The length of time during and after treatment for which a patient is living with a disease that does
not get worse. Progression-free survival may be measured in a clinical study or trial to help find out
how well a new treatment works.
protein expression
Refers to the production of protein by cells. The study of protein expression in cancer cells may give
information about a specific type of cancer, the best treatment to use and how well a treatment works.
proto-oncogene
A gene involved in normal cell growth. Mutations (changes) in a proto-oncogene may cause it to
become an oncogene, which can cause the growth of cancer cells.
prostate-specific antigen (PSA)
A protein made by the prostate gland and found in the blood. PSA blood levels may be higher
than normal in men who have prostate cancer, benign prostatic hyperplasia (BPH) or infection or
inflammation of the prostate gland.
quality of life
The overall enjoyment of life. Many clinical trials assess the effects of cancer and its treatment on
quality of life. These studies measure aspects of an individuals sense of wellbeing and ability to
carry out various activities.
reactive oxygen species
A type of unstable molecule that contains oxygen and that easily reacts with other molecules in a
cell. A build up of reactive oxygen species in cells may cause damage to DNA, RNA and proteins,
and may cause cell death. Reactive oxygen species are free radicals. Also called oxygen radical.
salvage therapy
Treatment that is given after the cancer has not responded to other treatments.
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signal transduction inhibitor
A substance that blocks signals passed from one molecule to another inside a cell. Blocking these
signals can affect many functions of the cell, including cell division and cell death, and may kill
cancer cells. Certain signal transduction inhibitors are being studied in the treatment of cancer.
signalling pathway
Describes a group of molecules in a cell that work together to control one or more cell functions, such
as cell division or cell death. After the first molecule in a pathway receives a signal, it activates another
molecule. This process is repeated until the last molecule is activated and the cell function is carried out.
Abnormal activation of signalling pathways can lead to cancer, and drugs are being developed to
block these pathways. These drugs may help block cancer cell growth and kill cancer cells.
stable disease
Cancer that is neither decreasing nor increasing in extent or severity.
stage
The extent of a cancer in the body. Staging is usually based on the size of the tumour, whether
lymph nodes contain cancer and whether the cancer has spread from the original site to other parts
of the body.
stem cell
A cell from which other types of cells develop. For example, blood cells develop from blood-forming
stem cells.
stereotactic body radiation therapy
A type of external radiation therapy that uses special equipment to position a patient and precisely
deliver radiation to tumours in the body (except the brain). The total dose of radiation is divided into
smaller doses given over several days. This type of radiation therapy helps spare normal tissue.
survivorship
In cancer, survivorship focuses on the health and life of a person with cancer post treatment until
the end of life. It covers the physical, psychosocial and economic issues of cancer, beyond the
diagnosis and treatment phases. Survivorship includes issues related to the ability to obtain health
care and follow-up treatment, late effects of treatment, second cancers and quality of life. Family
members, friends and caregivers are also considered part of the survivorship experience.
synergistic
In medicine, describes the interaction of two or more drugs when their combined effect is greater
than the sum of the effects seen when each drug is given alone.
T cell
A type of white blood cell. T cells are part of the immune system and develop from stem cells in the
bone marrow. They help protect the body from infection and may help fight cancer. Also called T
lymphocyte and thymocyte.
targeted therapy
A type of treatment that uses drugs or other substances to identify and attack specific types
of cancer cells with less harm to normal cells. Some targeted therapies block the action of
certain enzymes, proteins or other molecules involved in the growth and spread of cancer cells.
Other types of targeted therapies help the immune system kill cancer cells or deliver toxic
substances directly to cancer cells and kill them. Targeted therapy may have fewer side effects
than other types of cancer treatment. Most targeted therapies are either small molecule drugs or
monoclonal antibodies.
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taxane
A type of drug that blocks cell growth by stopping mitosis (cell division). Taxanes interfere with
microtubules (cellular structures that help move chromosomes during mitosis). They are used to
treat cancer. A taxane is a type of mitotic inhibitor and a type of antimicrotubule agent.
telomerase
An enzyme in cells that helps keep them alive by adding DNA to telomeres (the ends of
chromosomes). Each time a cell divides, the telomeres lose a small amount of DNA and become
shorter. Over time, the chromosomes become damaged and the cells die. Telomerase helps keep
this from happening. Cancer cells usually have more telomerase than most normal cells.
thrombolysis
The process of breaking up a thrombus (blood clot) that is blocking blood flow. The blood clot may
be dissolved using drugs delivered through a catheter (tube) into the clot.
thrombophlebitis
Inflammation of a vein that occurs when a blood clot forms.
thymidylate synthase
An enzyme involved in making and repairing DNA. High levels of thymidylate synthase may be
involved in how certain types of cancer form and respond to treatment.
time to progression (TTP)
The length of time from the date of diagnosis or the start of treatment for a disease until the
disease starts to get worse or spread to other parts of the body. In a clinical trial, measuring the
time to progression is one way to see how well a new treatment works.
TNM staging system
A system to describe the amount and spread of cancer in a patients body. T describes the size of
the tumour and any spread of cancer into nearby tissue; N describes the spread of cancer to
nearby lymph nodes; and M describes metastasis (spread of cancer to other parts of the body).
This system was created and is updated by the American Joint Committee on Cancer (AJCC) and
the International Union Against Cancer (UICC). The TNM staging system is used to describe most
types of cancer.
topoisomerase inhibitor
A substance that blocks topoisomerase (enzymes that break and rejoin DNA strands and are
needed for cells to divide and grow). Blocking these enzymes may kill cancer cells. Certain
topoisomerase inhibitors are being studied in the treatment of cancer.
total parenteral nutrition (TPN)
A form of nutrition that is delivered into a vein. Total parenteral nutrition does not use the digestive
system. It may be given to people who are unable to absorb nutrients through the intestinal tract
because of persistent vomiting, severe diarrhoea or intestinal disease. It may also be given to those
undergoing high-dose chemotherapy or radiation and bone marrow transplantation. It is possible
to give all of the protein, calories, vitamins and minerals a person needs using total parenteral
nutrition. Also called hyperalimentation and parenteral nutrition.
transcription
In biology, the process by which a cell makes an RNA copy of a gene (sequence of DNA).
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tumour lysis syndrome
A condition that can occur after treatment of a fast-growing cancer, especially certain leukaemias
and lymphomas (cancers of the blood). As tumour cells die, they break apart and release their
contents into the blood. This causes a change in certain chemicals in the blood, which may cause
damage to organs, including the kidneys, heart and liver.
tumour necrosis factor (TNF)
A protein made by white blood cells in response to an antigen or infection. TNF can also be made in
the laboratory. It may boost a persons immune response, and also may cause necrosis (cell death)
of some types of tumour cells. TNF is being studied in the treatment of some types of cancer. It is a
type of cytokine.
tumour suppressor gene
A type of gene that makes a protein called a tumour suppressor protein that helps control cell
growth. Mutations (changes in DNA) in tumour suppressor genes may lead to cancer. Also called
antioncogene.
tyrosine kinase inhibitor
A substance that blocks the action of enzymes called tyrosine kinases. Tyrosine kinases are involved
in many cell functions, including cell signalling, growth and division. These enzymes may be too
active or found at high levels in some types of cancer cells, and blocking them may help keep
cancer cells from growing. Some tyrosine kinase inhibitors are used to treat cancer. They are a type
of targeted therapy.
vascular endothelial growth factor (VEGF)
A substance made by cells that stimulates new blood vessel formation.
whole-brain radiation therapy (WBRT)
A type of external radiation therapy used to treat patients who have cancer in the brain. It is often
used to treat patients whose cancer has spread to the brain, or who have more than one tumour or
tumours that cannot be removed by surgery. Radiation is given to the whole brain over a period of
many weeks. Also called whole-brain radiotherapy.
wedge resection
Surgery to remove a triangle-shaped slice of tissue. It may be used to remove a tumour and a small
amount of normal tissue around it.
Reference
National Cancer Institute at the National Institutes of Health. NCI Dictionary of Cancer Terms. Available from:
http://www.cancer.gov/dictionary (accessed 14 January 2014).
Lilly Handbook of Systemic Treatments for Cancer 8th Edition
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Appendix 2
NCI CTCAE v4.0
This is an abbreviated adaption from the original publication by the US National Cancer Institute.
Please refer to the original publication at: http://evs.nci.nih.gov/ftp1/CTCAE/About.html
Grade 1 Grade 2 Grade 3 Grade 4
Blood and lymphatic system disorders
Anaemia
Haemoglobin
(Hgb)
<LLN10.0g/dL;
<LLN6.2mmol/L;
<LLN100g/L
<10.08.0g/dL;
<6.24.9mmol/L;
<10080g/L
<8.0g/dL;
<4.9mmol/L;
<80g/L;
transfusion indicated
Life-threatening;
urgent intervention
indicated
Febrile
neutropenia
Absolute
neutrophil count
(ANC)
<100/mm
3
with a
single temperature
of >38.3C or
a sustained
temperature of
38C for more than
1 hr
Life-threatening;
urgent intervention
indicated
Ear and labyrinth disorders
Ear pain Mild pain Moderate pain Severe pain
Tinnitus Mild symptoms Moderate symptoms Severe symptoms
Eye disorders
Conjunctivitis Asymptomatic or
mild symptoms
Symptomatic;
topical intervention
indicated
Limiting self care
activities of daily
living
Gastrointestinal disorders
Dry mouth Dry or thick saliva
without significant
dietary alteration
Oral intake alteration
(eg, copious water,
other lubricants, diet
limited to purees
and/or soft, moist
foods)
Inability to
adequately aliment
orally; tube feeding
or TPN indicated
Fever 38.039.0C >39.040.0C >40.0C for 24 hrs >40.0C for >24 hrs
Flu-like
symptoms
Mild flu-like
symptoms present
Moderate symptoms;
limiting instrumental
activities of daily
living
Severe symptoms;
limiting self care
activities of daily
living
Infusion-related
reaction
Mild; infusion
interruption not
indicated
Therapy or infusion
interruption
indicated but
responds promptly
to antihistamines,
NSAIDs, narcotics,
IV fluids; prophylactic
medications
indicated for 24 hrs
Prolonged
recurrence of
symptoms following
initial improvement;
hospitalisation
indicated
Life-threatening;
urgent intervention
indicated
Infusion site
extravasation
Erythema with
associated
symptoms (eg,
oedema, pain,
induration, phlebitis)
Ulceration or
necrosis; severe
tissue damage;
operative
intervention
indicated
Life-threatening;
urgent intervention
indicated
Injection site
reaction
Tenderness with or
without associated
symptoms (eg,
warmth, erythema,
pruritus)
Pain; lipodystrophy;
oedema, phlebitis
Ulceration or
necrosis; severe
tissue damage;
operative
intervention
indicated
Life-threatening;
urgent intervention
indicated
Investigations
Alkaline
phosphatase
increased
>ULN2.5 x ULN >2.55.0 x ULN >5.020.0 x ULN >20.0 x ULN
Blood bilirubin
increased
>ULN1.5 x ULN >1.53.0 x ULN >3.010.0 x ULN >10.0 x ULN
Creatinine
increased
>11.5 x baseline;
>ULN1.5 x ULN
>1.53.0 x baseline;
>1.53.0 x ULN
>3.0 baseline;
>3.06.0 x ULN
>6.0 x ULN
Lymphocyte
count decreased
<LLN800/mm
3
;
<LLLN0.8 x 10
9
/L
<800500/mm
3
;
<0.80.5 x 10
9
/L
<500200/mm
3
;
<0.50.2 x 10
9
/L
<200/mm
3
;
<0.2 x 10
9
/L
Lymphocyte
count increased
>400020,000/mm
3
>20,000/mm
3
Neutrophil count
decreased
<LLN1,500/mm
3
;
<LLN1.5 x 10
9
/L
<1,5001,000/mm
3
;
<1.51.0 x 10
9
/L
<1,000500/mm
3
;
<1.00.5 x 10
9
/L
<500/mm
3
;
<0.5 x 10
9
/L
Platelet count
decreased
<LLN75,000/mm
3
;
<LLN75.0 x 10
9
/L
<75,00050,000/mm
3
;
<75.050.0 x 10
9
/L
<50.00025,000/mm
3
;
<50.025.0 x 10
9
/L
<25.000/mm
3
;
<25.0 x 10
9
/L
Serum amylase
increased
>ULN1.5 x ULN >1.52.0 x ULN >2.05.0 x ULN >5.0 x ULN
Urine output
decreased
Oliguria
(<80ml in 8 hrs)
Anuria
(<240ml in 24 hrs)
Weight gain 5<10% from
baseline
10<20% from
baseline
20% from baseline
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173
Grade 1 Grade 2 Grade 3 Grade 4
Investigations continued
Weight loss 5<10% from
baseline;
intervention not
indicated
10<20% from
baseline; nutritional
support indicated
20% from baseline;
tube feeding or TPN
indicated
Rash -
maculopapular
Macules/papules
covering <10% BSA
with or without
symptoms (eg,
pruritus, burning,
tightness)
Macules/papules
covering 1030%
BSA +/- symptoms;
limiting instrumental
activities of daily
living
Macules/papules
covering >30% BSA
+/- symptoms;
limiting self care
activities of daily
living
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Appendix 3
The cell cycle
M PHASE = MITOSIS
R = RESTRICTION POINT
(Cell commits to cell division and
enters S-phase)
Prophase
Chromosomes
(containing DNA)
form identical pairs
(called chromatids)
and move towards
the centre of the
cell
Metaphase
Spindle fibres
attach to
chromosomes;
chromatids begin to
separate
Anaphase
Two sets of new
single-stranded
chromosomes move
to opposite ends of
the cell
Telephase
A nuclear
membrane forms
around each set of
chromosomes; a
membrane divides
the cell in two
S-PHASE =
SYNTHESIS PHASE
(DNA replication)
G2 PHASE =
SECOND GAP PHASE
(Preparation for mitosis)
G1 PHASE =
FIRST GAP PHASE
(Metabolic changes occur to
prepare cell for division)
G0 = CELL CYCLE
ARREST
INTERPHASE = G1 + S + G2
(Period between mitotic divisions)
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175
Creatinine clearance
Determines an estimate of glomerular filtration rate using age and serum creatinine concentration.
Calculate estimated creatinine clearance using the Cockcroft and Gault
1
formula:
Estimated creatinine
Clearance (ml/min) =
(140 age) x weight x sex-dependent constant
serum creatinine
Age (years); weight (kg); serum creatinine (micromol/L)
Sex-dependent constant
Male = 1.23
Female = 1.04
Body surface area (BSA)
The Mosteller
2
formula
BSA (m
2
) =
height (cm) x weight (kg)
3600
Appendix 4
Useful formulae
Please note that these formulae are examples of the various published formulae for calculating,
for example, body surface area. These are presented as a guide and it is the responsibility of the
practitioner to refer to local protocols and/or guidelines.
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Calverts formula for carboplatin dosing
The systemic drug exposure produced by any dose of carboplatin in a patient can be reasonably
estimated on the basis of his or her renal function. Calverts formula
3
of delivering a calculated dose
in terms of target carboplatin area under the time-concentration curve (AUC) and a measured or
estimated glomerular filtration rate (GFR) has been widely used.
Please refer to your local protocol or the relevant SPC for the recommended target AUC.
Note: with the Calvert formula, the total dose of carboplatin is calculated in mg, not mg/m
2
.
Dose (mg) = target AUC (mg/ml x min) x [GFR ml/min + 25]
References
1. Cockcroft DW, Gault MH. Prediction of creatinine clearance from serum creatinine. Nephron 1976; 16: 31-41.
2. Mosteller RD. Simplified calculation of body surface area. N Engl J Med 1987; 317: 1098.
3. Calvert AH, Newell DR, Gumbrell LA et al. Carboplatin dosage: prospective evaluation of a simple formula
based on renal function. J Clin Oncol 1987; 7: 1748-56.
A Medical Education Goods and Services item by Lilly Oncology UK
UKONC00326 February 2014