New Drugs: 2012 and 2013

NEW DRUGS: 2012 AND 2013

AZILECT (rasagiline)
Drug class: Irreversible MAO-B inhibitor
Indication: Parkinsons disease
Contraindications, precautions:

Contraindicated - hepatic impairment, drugs that may contribute to serotonin toxicity (eg.
other MAOIs, SSRIs, St Johns wort, TCAs, pethidine, tramadol etc)

Precautions high dose, pregnancy and lactation, children <18 years

Adverse effects: Serotonin syndrome, postural hypotension, headache, flu like symptoms, fever,
malaise, neck pain, GI upset, weight loss, depression, vertigo, rhinitis, conjunctivitis, hallucination
Dose: 1mg daily (may have to reduce levodopa dose if they are used together)
Monitoring: Monitor for suicidal behaviour frequently and carefully when initiating treatment;
monitor for hypotension
Counselling:

Caution when standing up too quickly

Avoid foods containing tyramine while and for 2 weeks after stopping treatment. Avoid
matured cheese, aged meat products, protein extracts, yeast extracts and soy bean
extracts etc

B12 LIQUID (cyanocobalamin)

Drug class: Vitamin supplement
Indication: Vitamin B12 deficiency
Contraindications, precautions:

Precautions - children
Adverse effects: Nil
Dose: Initial: 1000mcg on alternate days for 1-2 weeks; maintenance: 1000mcg once a month
Monitoring: Monitor potassium concentration during initiation of vitamin B12 treatment and correct
hypokalaemia as needed; monitor vitamin B12 and blood count every year
Counselling:

Should not replace a balanced diet

CAYSTON (aztreonam)
Drug class: Monobactam antibiotic
Indication: Infections caused by Gram-negative aerobes eg. septicaemia, lower respiratory tract
infections caused by P.aeruginosa in cystic fibrosis; or other antibiotics are ineffective or cant be
used due to severe penicillin allergy
Contraindications, precautions:

Contraindications lysine allergy

Precautions renal impairment; limited information on use of inhalation in children 6-12

years
Adverse effects: Bronchospasm, cough, nasal congestion, wheezing, dyspnoea, joint swelling,
chest discomfort, headache
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New Drugs: 2012 and 2013

Dose: 75mg inhaled tid for 28 days. Inhale over 2-3 minutes using the Altera Nebulizer.
Monitoring: Measure FEV1 before and after the first dose in case bronchospasm requiring
treatment occurs
Counselling:

Use bronchodilator before each dose

Complete whole course (28 days)

EYLEA (aflibercept)
Drug class: Recombinant fusion protein; anti-vascular endothelial growth factor
Indication: Wet age-related macular degeneration
Contraindications, precautions:

Contraindications active intraocular inflammation; infection

Precautions poorly controlled glaucoma, pregnancy, lactation, children

Adverse effects: Conjunctival haemorrhage, cataract, eye pain, retinal detachment; corneal
erosion and oedema; blurred vision, foreign body sensation, increase intraocular pressure
Dose: Intravitreal injection: 2mg monthly for 3 consecutive months then reduce to every 2 months
Monitoring: Monitor intraocular pressure
Counselling:

Intravitreal injection carried out by qualified physician under local anaesthesia

Antibacterial eye drops to be used for 3-5 days after each injection

GLYPRESSIN INJECTION (terlipressin)

Drug class: Vasopressin analogue
Indication: Treatment of bleeding oesophageal varices
Contraindications, precautions:

Contraindications pregnancy

Precautions cerebral vascular disease, cardiac arrhythmia, renal impairment, uncontrolled

hypertension, previous MI, severe asthma, COPD, electrolyte imbalance, unstable angina,
elderly, lactation, children
Adverse effects: Headache, peripheral vasoconstriction, hypertension, GI upset, hyponatraemia,
AF, tachycardia, chest pain, MI, fluid overload, hot flushes, skin necrosis
Dose: Inject 1.7mg q4h; may adjunct to 0.85mg q4h when bleeding is under control.
Monitoring: Monitor blood pressure and heart rate
Counselling:

Treatment duration no more than 48 hours

MOVIPREP (macrogol/NaCl/ascorbic acid/KCl)

Drug class: Osmotic laxative
Indication: Bowel preparation before surgery and diagnostic procedures
Contraindications, precautions:

Contraindications severe dehydration, intestinal obstruction, bowel perforation, severe

colitis or Crohns

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New Drugs: 2012 and 2013

Precautions renal impairment, heart failure, dehydration, electrolyte imbalance, diabetes,

pregnancy, elderly, children <2 years
Adverse effects: Nausea, vomiting, diarrhoea, anal irritation, cramps or pain
Dose: Mix sachet A and B with 1L over water and drink over 1-2 hours. Repeat procedure
Monitoring:
Counselling:

Drink an extra 1L of clear liquid (water, clear soup, soft drink) during treatment.

Reconstitute Moviprep in water for 5 minutes and can be stored cooled and used within 24
hours.

Complete at least 1 hour before procedure.

OMNARIS SPRAY (ciclesonide)

Drug class: Corticosteroid
Indication: Seasonal allergic rhinitis (>6 years) and perennial allergic rhinitis (>12 years)
Contraindications, precautions:

Precautions nasal mucosa infection, hypersensitivity, recent systemic steroid treatment;

surgery, untreated fungal/bacterial infection, chicken pox, measles, glaucoma, elderly
Adverse effects: Headache, ear pain, candidiasis, oedema, dyspnoea
Dose: 2 sprays (100mcg) into each nostril once daily
Monitoring: Monitor for adrenal insufficiency and nasal mucosa infection
Counselling:

Shake before use and prime pump by spraying 8 times before first use. Reprime with 1
spray if havent used for 4 days.

ORALAIR (allergen extracts)

Drug class: Grass pollen extract
Indication: Grass pollen allergic rhinitis (>5 years old)
Contraindications, precautions:

Contraindication beta-blockers, severe unstable asthma, severe immune deficiency,

autoimmune disease, cancer, oral inflammation, glucose-galactose malabsorption

Precautions oral surgery, dental extraction, galactose intolerance, Lapp lactase

deficiency, pregnancy, lactation
Adverse effects: Throat irritation, headache, fatigue, conjunctivitis, dyspnoea, oral mucosal
blisters, pain, nasal congestion, sneezing, GI upset, swollen tongue, asthma, dizziness, anxiety,
chest pain
Dose: Dissolve tablet under tongue in the morning then swallow. Start with 100 IR on day one, 200
IR on day two then 300 IR thereafter.
Monitoring: confirm allergy through cutaneous IgE test
Counselling:

Take tablets on an empty stomach (1 hour before or 2 hours after food).

Start 4 months before pollen season and continue during pollen season.

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New Drugs: 2012 and 2013

PALEXIA SR (tapentadol)
Drug class: Analgesic with opioid agonist and noradrenaline reuptake inhibiting properties
Indication: Moderate-severe pain
Contraindications, precautions:

Contraindications respiratory depression, severe asthma, alcohol abuse, hypnotics,

concomitant MAOIs

Precautions hepatic and renal impairment, coma, head injury, brain tumour, seizures,
elderly, pregnancy, lactation, children <18 years old
Adverse effects: GI upset, drowsiness, headache, dry month, fatigue, reduced appetite, anxiety,
depression, tremor, muscle contractions, flushing, dyspnoea, dependence, abrupt withdrawal
Dose: Initially 50mg bd, increase by increments of 50mg per day every 3 days depending on
response; maximum 500mg/day
Monitoring: Monitor for signs of abuse and addiction
Counselling:
Withdraw gradually

PICATO GEL (ingenol)

Drug class: Topical chemotherapeutic
Indication: Solar actinic keratosis
Contraindications, precautions:

Precautions previous skin treatment, excessive sunlight, tanning bed exposure,

pregnancy, lactation, children
Adverse effects: Pain on application site, pruritus, irritation, infection, erythema, flaking, crusting,
swelling, ulceration, headache, eyelid oedema
Dose: Apply 0.015% gel (to face and scalp) or 0.05% gel (to body) to affected area once daily for 3
consecutive days.
Monitoring:
Counselling:

Wash hands immediately after application. Leave gel on skin for at least 6 hours.

Do not apply immediately before or after a shower, or <2 hours before bedtime.

RESOTRANS (prucalopride)
Drug class: 5HT4 receptor agonist
Indication: Chronic idiopathic constipation when other laxatives are inadequate
Contraindications, precautions:

Contraindications dialysis, intestinal obstruction and perforation, active intestinal tract

inflammation (Crohns disease, ulcerative colitis, recent bowel surgery)

Precautions cardiovascular disease, arrhythmias, pregnancy, lactation, children <18

years old, galactose intolerance
Adverse effects: Headache, dizziness, nausea, abdominal pain, diarrhoea, fatigue, tremor,
palpitation
Dose: 2mg once daily
Monitoring: Reassess continuing treatment after 12 weeks
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New Drugs: 2012 and 2013

Counselling:

Has an onset within the first few weeks. Stop if no improvement after 4 weeks.

TRAUMEEL CREAM and TRAUMEEL S TABLETS (herbal achillea, arnica, calendula etc)
Drug class: Herbal analgesic and anti-inflammatory
Indication: Pain relief for soft tissue trauma, sprains, strains, swelling, sore aching muscles and
arthritic pain; symptomatic relief of mild to moderate acne, mouth ulcers, tonsilitis
Contraindications, precautions:

Precautions: children <2 years, prolonged use

Adverse effects: local skin reaction (cream)
Dose: Apply cream twice daily. Dissolve one tablet three times daily in mouth.
Counselling:

For acute conditions, can use 1 tablet every 30min-1 hr up to 12 times daily.

For children 6-11 years: 1 bd ; children 2-5 years: 0.5 tid

VALOID INJECTION (cyclizine)

Drug class: Piperazine anti-histamine anti-emetic
Indication: Prevention of postoperative nausea and vomiting
Contraindications, precautions:

Contraindications severe heart failure

Precautions urinary retention, glaucoma, asthma, COPD, pregnancy, lactation

Adverse effects: Drowsiness, headache, tremor, convulsions, dizziness, agitation,
agranulocytosis, tachycardia, blurred vision, mouth dryness, constipation
Dose: 50mg IV tid
Counselling:

Commence treatment within 24 hours of surgery and no more than 48 hours. Administer
20min before end of surgery.

VICTOZA INJECTION (liraglutide)

Drug class: Glucagon-like peptide-1 analogue
Indication: Type 2 diabetes
Contraindications, precautions:

Precautions congestive heart failure, hepatic/renal impairment, thyroid, inflammatory

bowel disease, dehydration, elderly, pregnancy, lactation, children <18 years
Adverse effects: GI upset, anorexia, GORD, hypoglycaemia, decreased appetite, headache, pain
at injection site, urticarial, oedema, pancreatitis, goitre,
Dose: 0.6mg/day injection for one week then increase to 1.2mg daily.
Monitoring: BSL, renal function
Counselling:

If adding to a sulfonylurea, reduce sulfonylurea dose by half.

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New Drugs: 2012 and 2013

XARELTO (rivaroxaban)
Drug class: Antithrombotic, factor Xa inhibitor
Indication: Prevention of VTE following hip or knee replacement; Treatment of DVT; Non-valvular
AF and high risk of stroke
Contraindications, precautions:

Contraindications pregnancy, lactation, active bleeding, moderate-severe renal

impairment, treatment with azoles or HIV PIs (strong inhibitors of CYP3A4 and Pglycoprotein)

Precautions bleeding disorder, uncontrolled arterial hypertension, active GI ulcer, recent

haemorrhage, renal impairment, lactose and galactose intolerance, glucose malabsorption.
Adverse effects: GI upset, haemorrhage, anaemia, increased menstrual bleeding, peripheral
oedema, itch, skin blisters, muscle spasm
Dose: Prevention of VTE 10mg daily for 2 weeks (after knee replacement) or 5 weeks (after hip
replacement)
Treatment of DVT 15mg bd for 3 weeks then 20mg daily
Prevention of emboli in AF 20mg daily
Monitoring: INR is not a measure of rivaroxabans anticoagulant effect
Counselling:

Take with food.

When switching to or from warfarin, measure INR at least 24 hours separate from the
rivaroxaban dose.

No antidote but prothrombin complex or recombinant factor VIIa may be used for overdose

XIFAXAN (rifaximin)
Drug class: Rifamycin antibiotic
Indication: Prevention of hepatic encephalopathy where other treatments are inappropriate
Contraindications, precautions:

Contraindications rifamycin hypersensitivity

Precautions hepatic/renal impairment, pregnancy, lactation, children <18 years

Adverse effects: GI upset, peripheral oedema, ascites, arthralgia, muscle spasm, dizziness
Dose: 550mg bd
Monitoring:
Counselling:

Use in conjunction with lactulose treatment

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New Drugs: 2012 and 2013

Miscellaneous
Immunosuppressants, chemotherapy, injections, infusions, other specialised drugs
BRAND NAME
Aubagio
Benlysta
Dysport

GENERIC NAME
teriflunomide
belimumab
botulinum

Edurant
Elaprase
Eviplera

rilpivirine
idursulfase
tenofovir, emtricitabine,
rilpivirine
telaprevir

Incivo
Inlyta
Jevtana
Menactra
Menopur
Naglazyme
Omegapharm
Acetylcysteine
Revolade

SmofKabiven
Sodium Ascorbate
Solution Injection for
Intravenous Infusion
Victrelis
VPRIV
Zelboraf
Zytiga
SAS
GyMiso

axitinib
cabazitaxel
neisseria meningitides
vaccine
human menopausal
gonadotrophin
galsulfase
acetylcysteine
eltrombopag

amino acids, lipids,

glucose, electrolytes.
sodium ascorbate

Boceprevir
velaglucerase alfa
vemurafenib
abiraterone
ofloxacin
misoprostol

Mifepristone
Linepharma
SAS

mifepristone

SAS

prothionamide

natamycin

CONDITION
Tablets for relapsing MS
Infusion for active, autoantibody +ve SLE
Injection for arm spasticity post-stroke,
spasmodic torticollis, blepharospasm,
hemifacial spasm, moderate to severe
glabellar lines
Tablets for HIV-1 infection
Injection for Hunter syndrome
Tablets for HIV-1 infection
Tablets for chronic hepatitis C virus in
patients with compensated liver disease
Tablets for advanced renal cell carcinoma
Infusion for prostate cancer
Injection to prevent meningococcal disease
Injection for infertility treatment
Injection for Mucopolysaccharidosis VI
Inhalation for acute, chronic
bronchopulmonary disease
Injection for chronic immune (idiopathic)
thrombocytopenic purpura after an
inadequate response (or intolerance) to
corticosteroids and immunoglobulin
Parenteral nutrition for adults
Infusion for vitamin C deficiency

Capsules for chronic hepatitis C infection

Infusion for Type 1 Gaucher disease
Tablets for metastatic melanoma
Tablets for prostate cancer
Leprosy
Termination of pregnancy up to 49 days in
combination with mifepristone
Termination of first or second trimester
pregnancy
Blepharitis, conjunctivitis or keratitis due to
susceptible fungi
TB (second line) with other agents

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New Drugs: 2012 and 2013

SAS
SAS

sufentanil
edrophonium

Cancer pain
Myasthenia gravis, as a diagnostic test or to
differentiate between under- and overtreatment

SAS
SAS

fomepizole
midodrine

SAS
SAS

nitazoxanide
pristinamycin

SAS

artesunate

Ethylene glycol or methanol poisoning

Orthostatic hypotension where standard
treatment is inadequate
Giardiasis, cryptosporidiosis
MRSA infections unresponsive or resistant to
other agents
Severe malaria (first line), chloroquineresistant malaria

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New Drugs: 2012 and 2013

References
1. eMIMS. 5.0. Sydney: MIMS Australia UBM Medica Pty Ltd; 2013
2. AMH. Adelaide: Australian Medicines Handbook Pty Ltd; 2013

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