Michael Rollins, PharmD Candidate Cone Health Family Medicine News You Can Use… Pete Koval, PharmD Michael Rollins, PharmD Candidate Cone Health Family Medicine June 2015

New Drug Approval Invega Trinza, a quarterly intramuscular injection formulation of paliperidone gained FDA approval for the treatment of schizophrenia Paliperidone is currently formulated as a once- daily tablet (Invega) and as a once-monthly injection (Invega Sustenna). Before patients begin quarterly injections, they must first receive monthly injections for at least 4 months. 05/19/2015 Medscape

New Drug Approval Stiolto Respimat (tiotropium/olodaterol), a once daily inhaler, has been approved by the FDA for maintenance treatment of airflow obstruction in COPD. Each actuation contains 2.5 mcg tiotropium and 2.5 mcg olodaterol. It is administered as 2 inhalations at the same time each day Common side effects include nasopharyngitis, cough, and back pain. 05/25/2015 FDA News and Events

New Drug Approval Humalog U-200 Kwikpen (insulin lispro): FDA approves new 200 unit/mL formulation indicated for improvement in glycemic control for type I and type II diabetes Humalog U-200 holds 600 units per pen compared to 300 units in the Humalog U-100 formulation. 05/27/2015 Pharmacy Times

Drug Launched Namzaric (memantine/donepezil), a fixed dose combination approved for treatment of moderate-severe dementia in Alzheimer’s disease, is now available Available in 14/10 mg (memantine/donepezil) and 28/10 mg strengths Capsules can be opened and sprinkled onto food for patients that have difficulty swallowing 05/20/2015 Pharmacy Times

New Indication Treximet (sumatriptan/naproxen), has been approved by the FDA for treatment of migraines with or without aura in pediatric patients 12 years of age or older. Previously was only indicated for adults aged 18+. Starting dose for pediatric patients is 10/60 mg (sumatriptan/naproxen sodium) daily with a max dose of 85/500 mg daily. 05/15/2015 FDA News and Events

New Drug Indication Viberzi (eluxadoline) and Xifaxan (rifaximin), both have received FDA approval for treatment of Irritable Bowel Syndrome with diarrhea (IBS-D). Side effects from eluxadoline are nausea, constipation and abdominal pain Side effects from rifaximin are increased ALT and nausea Eluxadoline is dosed 75 mg or 100 mg twice daily with food. Rifaximin is dosed 550 mg three times daily for 14 days. Patients can be retreated twice with same regimen. 05/25/2015 FDA News and Events

Generic Launched The generic form of Seasonale, levonorgestrel and ethinyl estradiol, 0.15 mg/0.03 mg, is now available. Seasonale is an extended cycle birth control form that contains 84 active pills and 7 inactive pills. 05/05/2015 Pharmacy Times

Orphan Drug Designation Humira (adalimumab), has been granted orphan status by the FDA to treat moderate-to-severe hidradenitis suppurativa Hidradenitis suppurativa, or “acne inversa” is a painful, chronic inflammatory skin disease for which there is no known cure and no approved medication. 05/18/2015 Pharmaceutical Business Review