Rx Product News

Marketed by: Pfizer Inc (New York, NY)

Indication: The FDA approved Xelijanz (tofacitinib citrate) for the treatment of adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response or intolerance to methotrexate. Xeljanz can be used as monotherapy or in combination with other nonbiologic disease-modifying antirheumatic drugs (DMARDs). It should not be used with biologic DMARDs or potent immunosuppressants. Xeljanz carries a boxed warning against the risks of serious infections and malignancy. The recommended dosage is 5 mg twice daily.

Dosage Form: Tablets: 5 mg

For More Information: www.xeljanz.com

Cystaran

Marketed by: SigmaTau Pharmaceuticals, Inc (Gaithersburg, MD)

Indication: Sigma-Tau Pharmaceuticals announced the approval of Cystaran (cysteamine ophthalmic solution) 0.44%, which was developed in partnership with the National Institutes of Health and with the support of an Orphan Drug grant from the FDA. Cystaran is indicated for the treatment of corneal cysteine crystal accumulation in patients with cystinosis, and is the only approved ophthalmic treatment for this condition. The recommended dosage is 1 drop instilled in each eye every waking hour.

Dosage Form: Sterile ophthalmic solution: 6.5 mg/mL cysteamine HCl

For More Information: www.sigmatau.com

Flucelvax

Marketed by: Novartis Vaccines and Diagnostics Inc (Cambridge, MA)

Indication: The FDA approved Flucelvax (Influenza Virus Vaccine), an inactivated vaccine indicated for the prevention of influenza caused by the influenza virus subtypes A and type B contained in the vaccine. Approved for adults 18 years and older, Flucelvax was developed and manufactured using cell-culture technology rather than egg-based production, and does not contain any preservatives, including thimerosal. Its use has not yet been established in pregnant or nursing mothers.

Dosage Form: Single-dose, pre-filled vials with suspension for intramuscular injection: 0.5 mL

For More Information: www.flucelvax.com

Xarelto

Marketed by: Janssen Pharmaceuticals Inc (Raritan, NJ)

Indication: Janssen announced that the FDA approved 3 new indications for the oral anticoagulant Xarelto (rivaroxaban) after priority review. Xarelto’s use is expanded to include the treatment of deep vein thrombosis (DVT) and/ or pulmonary embolism (PE) and to reduce the risk of recurrence of DVT or PE following initial treatment. For the new indications, the recommended dosage is 15 mg orally twice daily with food for the first 21 days for the initial treatment of DVT or PE and 20 mg once daily for the remaining treatment period.

Dosage Form: Tablets: 10, 15, and 20 mg

For More Information: www.xareltohcp.com

Actemra

Marketed by: Genentech, Inc, a member of the Roche Group (South San Francisco, CA)

Indication: The FDA approved an expansion of the indication of Actemra (tocilizumab) for the treatment of adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response to 1 or more diseasemodifying antirheumatic drugs (DMARDs). The recommended starting dose when used as monotherapy or with DMARDs is 4 mg per kg every 4 weeks, followed by an increase to 8 mg/kg every 4 weeks based on clinical response.

Dosage Form: Single-use vials for intravenous infusion: 80 mg/4 mL, 200 mg/10 mL, and 400 mg/20 mL

For More Information: www.actemra.com

Promacta

Marketed by: GlaxoSmithKline (Philadelphia, PA)

Indication: GlaxoSmithKline announced that the FDA approved Promacta (eltrombopag) for the treatment of thrombocytopenia (low blood platelet counts) in patients with chronic hepatitis C to allow them to initiate and maintain interferon-based therapy. For chronic hepatitis C—related thrombocytopenia, Promacta should be initiated at 25 mg once daily for all patients and adjusted to achieve the target platelet count. Dosage should not exceed 100 mg per day. Promacta tablets carry a boxed warning against the risk of hepatotoxicity.

Dosage Form: Tablets: 12.5, 25, 50, 75, and 100 mg

For More Information: http://us.gsk.com