Bayer HealthCare Pharmaceuticals Inc
The FDA has approved Xofigo, an alpha particle–emitting radioactive therapeutic agent, for the treatment of patients with castration-resistant prostate cancer, symptomatic bone metastases, and no known visceral metastatic disease. The recommended dosage is 50 kBq (1.35 microcurie) per kilogram of body weight, given at 4-week intervals for 6 injections. It should be administered by slow intravenous injection over 1 minute. Xofigo is contraindicated for use during pregnancy.
Single-use vial: 1000 kBq/mL (27 microcurie/mL)
For More Information: www.xofigo-us.com
The FDA has approved Botox Cosmetic (onabotulinumtoxinA) for temporary improvement of moderate to severe lateral canthal lines (crow’s feet lines) in adults. The recommended dosage is 0.1 mL (4 units) into each of 3 sites per side (6 total injection points), for a total of 24 units. Contraindications for use include (1) hypersensitivity to any botulinum toxin preparation and (2) infection at the injection site.
Single-use vial: 50 or 100 units vacuum-dried powder for reconstitution
For More Information: www.botoxcosmetic.com
CSL Behring AG
The FDA has expanded the administration options for Hizentra—an immune globulin subcutaneous (human), 20% liquid indicated for the treatment of primary immunodeficiency—to include dosing once every 2 weeks in addition to weekly dosing. For details on dosing, see the full prescribing information. Contraindications for use include (1) anaphylactic or severe systemic reaction to human immune globulin and (2) hyperprolinemia (type I or II).
Subcutaneous injection: 0.2 g per mL (20%) protein solution
For More Information: www.hizentra.com
The FDA has approved Abraxane (paclitaxel protein-bound particles for injectable suspension [albumin-bound]) in combination with gemcitabine (Gemzar; Lilly) as first-line treatment for patients with metastatic adenocarcinoma of the pancreas. The recommended dosage is 125 mg/m2 IV over 30 to 40 minutes on days 1, 8, and 15 of each 28-day cycle; gemcitabine should be administered on days 1, 8, and 15 of each 28-day cycle immediately after Abraxane.
Single-use vial: lyophilized powder containing 100 mg of paclitaxel for reconstitution
For More Information: www.abraxane.com