sanofi-aventis US LLC (Bridgewater, NJ)
Auvi-Q (epinephrine injection, USP) is a nonselective alpha- and beta-adrenergic agonist indicated for the emergency treatment of allergic reactions, including anaphylaxis. It is the first and only auto-injector that features audio and visual cues that guide patients and caregivers through the injection process. Each single-use injector can be used intramuscularly or subcutaneously in the anterolateral aspect of the thigh, through clothing if necessary. Dosage is based on patient weight.
Pre-filled auto injectors: 0.3 mg (0.3 mg/0.3 mL epinephrine injection, USP) and 0.15 mg (0.15 mg/0.15 mL epinephrine injection, USP)
For More Information: www.auvi-q.com
Genzyme, a Sanofi company (Cambridge, MA)
Genzyme, a Sanofi company, announced the FDA approval of Aubagio (teriflunomide), a pyrimidine synthesis inhibitor indicated for patients with relapsing forms of multiple sclerosis. Aubagio is a once-daily oral treatment that can be administered with or without food. The product carries a boxed warning describing risks of hepatotoxicity and teratogenicity, and is contraindicated in patients with severe hepatic impairment and those who are pregnant, as well as in patients currently taking leflunomide.
Film-coated tablets: 7 and 14 mg
For More Information: www.aubagio.com
Medivation, Inc (San Francisco, CA) and Astellas Pharma Inc (Tokyo, Japan)
Indication: The FDA approved Xtandi (enzalutamide) for the treatment of patients with metastatic castrationresistant prostate cancer who have previously received docetaxel. An androgen receptor inhibitor, Xtandi is being distributed through specialty pharmacies and specialty distributors with a patient access support program called Xtandi Access Services. The dosage of Xtandi is 160 mg given as four 40-mg capsules once daily, taken with or without food, and capsules must be swallowed whole.
Capsule: 40 mg
For More Information: www.xtandihcp.com
Ironwood Pharmaceuticals (Cambridge, MA) and Forest Laboratories, Inc (New York, NY)
Indication: Linzess (linaclotide) was approved for the treatment of irritable bowel syndrome with constipation (IBSC) and chronic idiopathic constipation (CIC) in adults. A guanylate cyclase-C agonist, Linzess should be taken on an empty stomach at least 30 minutes prior to the patient’s first meal of the day. For IBS-C, the dosage is 290 mcg orally once daily, and for CIC, the dosage is 145 mcg orally once daily. The product has a boxed warning against its use in pediatric populations.
Capsules: 145 and 290 mcg
For More Information: www.linzesshcp.com
Gilead Sciences, Inc (Foster City, CA)
The FDA approved Stribild (elvitegravir, cobicistat, emtricitabine, tenofovir disoproxil fumarate) for the treatment of HIV-1 infection in treatment-naïve adults. The recommended dose of Stribild is 1 tablet taken once daily with food. Its packaging information specifies that it should not be initiated in patients with an estimated creatinine clearance (CrCl) less than 70 mL/min and should be discontinued in patients with an estimated CrCl less than 50 mL/min.
Tablets: elvitegravir 150 mg, cobicistat 150 mg, emtricitabine 200 mg, and tenofovir disoproxil fumarate 300 mg
For More Information: www.stribild.com/hcp
Janssen Pharmaceuticals Inc (Raritan, NJ)
The FDA approved Janssen’s supplemental New Drug Application for Nucynta ER (tapentadol) extended-release oral tablets CII for the management of neuropathic pain associated with diabetic peripheral neuropathy in adults when a continuous, around-the-clock opioid analgesic is needed for an extended period. A Schedule II substance, Nucynta ER carries a boxed warning for its abuse potential and the risks of life-threatening respiratory depression, accidental exposure, and interaction with alcohol. It is not for as-needed use or for mild, acute, or most types of post-operative pain.
Extended-release tablets: 50, 100, 150, 200, and 250 mg
For More Information: www.nucynta.com