BRAND NAME: Kineret GENERIC NAME: anakinra Approved January 2013 INDICATION: Treat people with the severe

form of Cryopyrin-Associated Periodic Syndromes (CAPS) called Neonatal-Onset Multisystem Inflammatory Disease (NOMID).

CONTRAINDICATION: have an infection, a history of infections that keep coming back or other problems that can increase your risk of infections. have an allergy to rubber or latex. The needle cover on the prefilled syringe contains latex. Do not handle the needle cover if you are allergic to latex. have kidney problems are scheduled to receive any vaccines. People using Kineret should not receive live vaccines. are pregnant or plan to become pregnant. It is not known if Kineret will harm your unborn baby. are breastfeeding or plan to breastfeed. It is not known if Kineret passes into your breast milk. You and your healthcare provider should decide if you will take Kineret or breastfeed.

COMMON SIDE EFFECTS: headache, nausea and vomiting, joint pain, sore throat or runny nose, sinus infection, pain in your stomach area, injection site skin reactions, including redness, swelling, bruising, itching, and stinging. Most injection site reactions are mild, occur early during treatment, and last about 2-4 weeks. Injection site reactions have been observed less frequently in people with NOMID. ADVERSE EFFECTS: low white blood cell count (neutropenia) SAFETY INFORMATION: have blood tests before starting treatment with Kineret, then monthly for 3 months. After the first 3 months you should have your blood tested every 3 months for up to 1 year. For allergic reactions. Stop using Kineret and call your healthcare provider or get emergency help right away if you have any of these symptoms of an allergic reaction: swelling of your face, lips, mouth or tongue; trouble breathing; wheezing; severe itching; skin rash, redness, or swelling outside of the injection site area; dizziness or fainting; fast heartbeat or pounding in your chest (tachycardia); or pounding in your chest (tachycardia) or sweating.

BRAND NAME: Kynamro GENERIC NAME : mipomersen sodium Approved January 2013 INDICATION: treatment of homozygous familial hypercholesterolemia CONTRAINDICATION: Moderate or severe hepatic impairment (Child-Pugh B or C) or active liver disease, including unexplained persistent elevations of serum transaminases. Patients with a known hypersensitivity to any component of this product.

COMMON SIDE EFFECTS: Flu-like symptoms, defined as any one of the following: influenza-like illness, pyrexia, chills, myalgia, arthralgia, malaise or fatigue and occurring within 2 days of injection ADVERSE EFFECTS: liver problems and drug toxicity SAFETY INFORMATION: Patients are advised to read the KYNAMRO medication guide before starting treatment with KYNAMRO, and each time they receive a refill. There may be new information. This information does not take the place of talking to a doctor about a medical condition or treatment. Alcohol may increase levels of hepatic fat and induce or exacerbate liver injury. It is recommended that patients taking KYNAMRO should consume no more than one alcoholic drink per day. KYNAMRO should be used during pregnancy only if clearly needed. Females who become pregnant during KYNAMRO therapy should notify their healthcare provider. Safety and effectiveness have not been established in pediatric patients. KYNAMRO is not recommended in patients with severe renal impairment, clinically significant proteinuria, or on renal dialysis. The safety and effectiveness of KYNAMRO as an adjunct to LDL apheresis have not been established; therefore, the use of KYNAMRO as an adjunct to LDL apheresis is not recommended.

BRAND NAME: Ravicti GENERIC NAME: glycerol phenylbutyrate Approved February 2013 INDICATION: adults and children 2 years of age and older for long-term management of high blood levels of ammonia (hyperammonemia) caused by a condition called a urea cycle disorder (UCD) CONTRAINDICATIONS: Have liver or kidney problems Have pancreas or bowel (intestine) problems Have any other medical conditions Are pregnant or plan to become pregnant. It is not known if RAVICTI will harm your unborn baby.

Are breastfeeding or plan to breastfeed. It is not known if RAVICTI passes into your breast milk. RAVICTI may harm your baby, so you and your doctor should decide if you will take RAVICTI or breastfeed children 2 months to less than 2 years of age.

COMMON SIDE EFFECTS: upper abdomen (stomach) pain, nausea, vomiting, diarrhea, decreased appetite, high blood levels of ammonia and headache ADVERSE EFFECTS: sleepiness, weakness, lightheadedness, change in taste, problems with hearing, confusion, problems with memory, worsening neuropathy (numbness, tingling, or burning in your hands or feet) and headache

BRAND NAME: Oxtellar XR GENERIC NAME: oxcarbazepine Approved October 2012 INDICATION: indicated as adjunctive therapy of partial seizures in adults and in children 6 years to 17 years of age. CONTRAINDICATIONS: in patients with a known hypersensitivity to oxcarbazepine or to any of its components. COMMON SIDE EFFECTS: dizziness, headache, stomachache and body malaise ADVERSE EFFECTS: dizziness, somnolence, headache, balance disorder, tremor, nausea, vomiting, diplopia, asthenia, and fatigue. SAFETY INFORMATION Measurement and laboratory tests of serum sodium concentrations should be considered for patients during maintenance treatment with Oxtellar XR (oxcarbazepine), particularly if the patient is receiving other medications known to decrease serum sodium levels Rare cases of anaphylaxis and angioedema involving the larynx, glottis, lips, and eyelids have been reported in patients after taking the first or subsequent doses of oxcarbazepine. Angioedema associated with laryngeal edema can be fatal Of patients who have had hypersensitivity to carbamazepine, 25% to 30% will experience a reaction to oxcarbazepine. Serious dermatological reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis, have been reported in association with oxcarbazepine use. Antiepileptic drugs (AEDs), including Oxtellar XR, increase the risk of suicidal behavior and ideation. Patients taking Oxtellar XR should be monitored for the emergence or worsening of depression, suicidal thoughts or behavior, and/or any unusual changes in mood or behavior. Patients and caregivers should also be advised to be alert for these behavioral changes and to immediately report them to the healthcare provider. Withdrawal of Oxtellar XR should be done gradually to minimize the potential of increased seizure frequency.

Multiorgan hypersensitivity reactions have been reported with antiepileptic drugs. If this reaction is suspected, Oxtellar XR should be discontinued. Rare reports of hematologic events such as pancytopenia, agranulocytosis, and leukopenia have been seen in patients treated with oxcarbazepine, and discontinuation of therapy should be considered if any evidence of these hematologic events develop. Due to physiological changes during pregnancy, plasma concentrations of the active metabolite of oxcarbazepine, the 10-monohydroxy derivative, may gradually decrease throughout pregnancy. It is recommended that patients be monitored carefully during pregnancy, through the postpartum period and delivery because the active metabolite concentrations or levels may increase. Enzyme inducing antiepileptic drugs such as carbamazepine, phenobarbital, and phenytoin decrease the exposure to MHD, the active metabolite of Oxtellar XR. Dosage increases may be necessary. In patients with severe renal impairment, initiate Oxtellar XR at a lower starting dose and increase, if necessary, at a slower than usual rate until the desired clinical response is achieved. Concurrent use of Oxtellar XR with hormonal contraceptives and other oral or implant contraceptives may decrease plasma levels and render these contraceptives less effective. Additional non-hormonal forms of contraception are recommended.

BRAND NAME: Sklice lotion GENERIC NAME: ivermectin Approved February 2012 INDICATION: pediculicide indicated for the topical treatment of head lice infestations in patients 6 months of age and older. CONTRAINDICATIONS: none COMMON SIDE EFFECTS: dry scalp ADVERSE EFFECTS: conjunctivitis, ocular hyperemia, eye irritation, dandruff, dry skin, and skin burning sensation SAFETY INFORMATION: Accidental ingestion in pediatric patients may occur. Administer only under direct adult supervision For topical use only. Not for oral, ophthalmic or intravaginal use. Apply Sklice Lotion to dry hair in an amount sufficient (up to 1 tube) to thoroughly coat the hair and scalp. After 10 minutes, rinse off with water. The tube is intended for single use. Discard any unused portion. Avoid contact with eyes.

BRAND NAME: Surfaxin GENERIC NAME: lucinactant Approved March 2012 INDICATION: This medication is a synthetic, peptide-containing surfactant, prescribed for respiratory distress syndrome (RDS) in premature infants. It helps the lungs function normally. CONTRAINDICATIONS: hyperventilating patients COMMON SIDE EFFECTS: Difficulty in breathing, bleeding in the lungs, decrease in lung function, brain injury, infections, tissue death. ADVERSE EFFECTS: slow heart rate, oxygen desaturation, reflux of medication into the endotracheal tube (ETT), and airway/ETT SAFETY INFORMATION It comes as a solution for injection, to be administered by a healthcare provider into the trachea (windpipe).

Patient should be given proper oxygen and ventilation support during the treatment period.

BRAND NAME: Actemra GENERIC NAME : tocilizumab Approved April 2011 INDICATION: treatment of systemic juvenile idiopathic arthritis CONTRAINDICATION: for patients with TB and manifestations of any kind of infections COMMON SIDE EFFECTS: fever, sweating, chills, muscle aches, cough, shortness of breath, blood in phlegm, weight loss; warm, red and painful skin sores, diarrhea or stomach pain and burning sensation when you urinate. ADVERSE EFFECTS: perforation of the stomach or intestines, cancer, hepa B, nervous system problems and serious allergic reactions SAFETY INFORMATION: Submit the patient a diagnostic test for TB before taking ACTEMRA

BRAND NAME: Onfi GENERIC NAME : clobazam Approved October 2011 INDICATION: adjunctive treatment of seizures associated with Lennox-Gastaut syndrome CONTRAINDICATIONS: pregnant women and for those planning to get pregnant. Breastfeeding mothers. COMMON SIDE EFFECTS: sleepiness, drooling, constipation, cough, pain in urination, fever, acting aggressive, being angry, difficulty sleeping, slurred speech, tiredness and problems with breathing. ADVERSE EFFECTS: status epilepticus, hsllucination, shaking, nervousness and stomach and muscle cramps SAFETY INFORMATION: Avoid doing hard works or lifting and driving. This medication can make you dizzy and can slow your thinking and make you clumsy which may get beter overtime. Avoid bruptly stopping taking this medications since this causes withdrawal symptoms This is a federaaly controlled substance because it can be abused or lead to dependence.

Like other antilepileptic drugs, NFI may cause suicidal thoughts or actions in a very small number of people.

BRAND NAME Daliresp GENERIC NAME roflumilast Approved February 2011 INDICATION: chronic obstructive pulmonary disease CONTRAINDICATIONS: Moderate to severe liver impairment (Child-Pugh B or C) COMMON SIDE EFFECTS: feverv and chills, nausea and vomiting ADVERSE EFFECTS: Most common adverse reactions ( 2%) are diarrhea, weight decrease, nausea, headache, back pain, influenza, insomnia, dizziness and decreased appetite SAFETY INFORMATION: Acute bronchospasm: Do not use for the relief of acute bronchospasm. Psychiatric Events including Suicidality: Advise patients , their caregivers, and families to be alert for the emergence or worsening of insomnia, anxiety, depression, suicidal thoughts or other mood changes, and if such changes occur to contact their healthcare provider. Carefully weigh the risks and benefits of treatment with DALIRESP in patients with a history of depression and/or suicidal thoughts or behavior. Weight Decrease: Monitor weight regularly. If unexplained or clinically significant weight loss occurs, evaluate weight loss and consider discontinuation of DALIRESP. Drug Interactions: Use with strong cytochrome P450 enzyme inducers (e.g. rifampicin, phenobarbital, carbamazepine, phenytoin) is not recommended.

BRAND NAME Kapvay GENERIC NAME clonidine Approved October 2010 INDICATION: treatment of Attention-Deficit Hyperactivity Disorder (ADHD) CONTRAINDICATIONS: allergy to clonidine, use cautiously to patients with high or low blood pressure, kidney problems or heart problems, including heart attacks or strokes. COMMON SIDE EFFECTS: sleepiness, tiredness, and upper respiratory tract infections. Symptoms may include cough, runny nose, sneezing, irritability, sore throat, trouble sleeping (insomnia), nightmares, change in mood, constipation, stuffy nose, increased body temperature, dry mouth, and ear pain. ADVERSE EFFECTS: depression, nightmares. Atrioventricular block, abnormal heart electrical signals, slow heartbeat, chronic heart failure, occasional numbness, prickling or tingling of fingers and toes, hepatitis, giant hives SAFETY INFORMATION: Avoid becoming dehydrated or overheated when taking KAPVAY.

KAPVAY can make you sleepy or dizzy. Do not drink alcohol or take other medicines that make you sleepy or dizzy while taking KAPVAY until you talk with your doctor. KAPVAY taken with alcohol or medicines that cause sleepiness or dizziness may make your sleepiness or dizziness worse Do not drive, operate heavy machinery, or participate in any dangerous activities until you know how KAPVAY will affect you Do not stop taking KAPVAY without talking to your doctor. Suddenly stopping KAPVAY may cause withdrawal symptoms, including increased blood pressure, headache, increased heart rate, light headedness, tightness in your chest, and nervousness Tell your doctor if you had a skin reaction (such as a rash) after taking clonidine in a transdermal form (skin patch). Talk to your doctor about any other medical conditions you have and all the medicines, including vitamins and herbal supplements, that you take