Pharmacy & Therapeutics - November 2008 - (Page 627)

NEW DRUGS NEW DRUGS Silodosin (Rapaflo) for the Enlarged Prostate Gland The Food and Drug Administration (FDA) has approved silodosin (Rapaflo, Watson), a therapy for prostate enlargement. This once-daily drug helps to reduce symptoms of benign prostatic hypertrophy (BPH), including urinary pain and resistance. Silodosin is a selective alpha1-adrenergic receptor antagonist and causes smooth muscles in prostatic tissue to relax, resulting in improved urine flow. It was originally developed by Kissei in Japan. (Sources: www.watson.com; Bloomberg News, October 8, 2008.) DRUG NEWS agulation proteins, known as factor VIII. Kogenate FS is contraindicated for patients with life-threatening immediate hypersensitivity to the product, including mouse or hamster proteins. (Sources: www.medicalnewstoday. com; www.kogenatefs.com.) duce rapid swelling of the hands, feet, limbs, face, intestinal tract, or airway. Swelling of the larynx can lead to asphyxiation. This C1-esterase inhibitor is derived from human plasma. It is given intravenously and can be used every three or four days. (Source: FDA, October 15, 2008.) NEW INDICATIONS Triamcinolone Nasal Spray (Nasacort) for Rhinitis In Young Children Sanofi-Aventis has announced the approval of triamcinolone acetonide (Nasacort AQ Nasal Spray) for children two to five years of age with nasal symptoms associated with seasonal and perennial allergic rhinitis. Given as one spray per nostril once daily for four weeks in young patients, the medication significantly improved the combined symptoms of sneezing, itching, runny nose and congestion, compared with placebo. This drug is also indicated for adults and children 12 years of age and older at a recommended starting and maximum dose of 220 mcg/day as two sprays in each nostril once daily. For children six to 12 years of age, the recommended starting dose is 110 mcg/ day, given as one spray in each nostril once daily. (Source: Sanofi-Aventis, September 23, 2008.) Pemetrexed (Alimta) For Nonsquamous Non–Small-Cell Lung Cancer Eli Lilly has received approval to market pemetrexed injection (Alimta), in combination with cisplatin (Platinol, Bristol-Myers Squibb), for the first-line treatment of locally advanced and metastatic nonsquamous non–small-cell lung cancer (NSCLC). Nonsquamous histology includes adenocarcinoma, large-cell carcinoma, and all other types except squamous cell carcinoma. This marks the drug’s third U.S. indication; it is also approved with cisplatin for malignant pleural mesothelioma and as a single agent for the second-line treatment of locally advanced or metastatic NSCLC after prior chemotherapy. (Source: Eli Lilly, September 29, 2008.) Denileukin (Ontak) In Cutaneous T-Cell Lymphoma An efficacy supplemental Biologics License Application (sBLA) for injectable denileukin diftitox solution (Ontak, Eisai) has been approved to treat persistent or recurrent cutaneous T-cell lymphoma (CTCL) in patients with malignant cells that express the CD25 component of the interleukin (IL)-2 receptor. Ontak is a genetically engineered cytotoxic fusion protein. CTCL refers to a group of rare malignant lymphomas that are manifested primarily in the skin. An accelerated approval for this agent had been granted in 1999. (Source: Eisai, October 15, 2008, www. eisai.com.) HIV Agent Darunavir (Prezista) In Combination For Treatment-Naive Adults The FDA has approved darunavir (Prezista, Tibotec/Ortho Biotech), a protease inhibitor, for once-daily dosing as par t of HIV combination therapy for treatment-naive adults with human immunodeficiency virus (HIV-1) infection. The FDA also granted full approval to darunavir as a twice-daily medication for treatment-experienced adults. In 2006, the FDA granted accelerated approval for darunavir to be taken with other antiretroviral agents in treatmentexperienced adults, such as patients with HIV-1 that was resistant to more than one protease inhibitor. The dose for treatment-naive adults is C1-Esterase Inhibitor (Cinryze) For Hereditary Angioedema The FDA has licensed the first product for marketing in the U.S. intended to protect patients with hereditary angioedema (HAE), a rare and potentially life-threatening genetic disease. Cinryze (Lev Pharmaceuticals) is indicated for preventing HAE attacks, which can occur spontaneously or during surgery, stress, or infection. Attacks can pro- Kogenate for Prevention Of Bleeding in Hemophilia A Bayer’s Kogenate FS Antihemophilic Factor (Recombinant) has been approved as routine prophylaxis to reduce the frequency of bleeding episodes and the risk of joint damage in patients from bir th to 16 years of age with severe hemophilia A with no pre-existing joint damage. Hemophilia A (classic hemophilia) is caused by deficient blood co- Vol. 33 No. 11 • November 2008 • P&T® 627 http://www.medicalnewstoday.com http://www.medicalnewstoday.com http://www.kogenatefs.com http://www.watson.com http://www.eisai.com http://www.eisai.com

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Pharmacy & Therapeutics - November 2008 Contents Editorial Medication Errors Prescription: Washington New Drugs/Drug News/New Medical Devices Drug Forecast Heparin-Induced Thrombocytopenia Medication Utilization Patterns and Hypertension-Related Expenditures among Patients Who Were Switched From Fixed-Dose to Free-Combination Antihypertensive Therapy European Society for Medical Oncology and Association for the Study of Bone and Mineral Research Pharmaceutical Approval Update

Pharmacy & Therapeutics - November 2008

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