Pharmacy & Therapeutics - February 2008 - (Page 76)

NEW DRUGS NEW DRUGS Etravirine (Intelence) For HIV Infection Etravirine tablets (Intelence, Tibotec/Ortho) have been approved by the Food and Drug Administration (FDA) after a priority review. This drug is indicated for the treatment of human immunodefieincy virus (HIV) infection in adults who have not responded to other antiretroviral agents. Etravirine is a non-nucleoside reverse transcriptase inhibitor (NNR TI) that helps to block an enzyme that the virus needs in order to multiply. When used with other active anti-HIV medications, it reduces the amount of virus in the blood and increases the number of white blood cells, which fight off other infections. Etravirine may also reduce the risk of death or infections that can occur with a weakened immune system. The approval was based primarily on data from 599 adults in two randomized, double-blind, placebo-controlled trials. (Source: FDA, January 18, 2008.) DRUG NEWS symptoms associated with hormone withdrawal. The new indication helps patients during their initial therapy for thyroid cancer. Thyrotropin alfa was originally approved in the U.S. in 1998 and Europe in 2001 for use in follow-up diagnostic procedures to detect recurrence. (Sources: Genzyme, December 17, 2007, www.thyrogen.com.) patients with sepsis is planned. For more information on Voluven, please see this month’s Pharmaceutical Approval Update column on page 114. (Source: FDA, December 28, 2007.) Generic Kytril (Granisetron) To Prevent Nausea and Vomiting Barr Laboratories, Inc., has received final approval from the FDA for its generic version of Roche’s Kytril (granisetron HCl) 1 mg. This medication is prescribed to prevent nausea and vomiting in patients undergoing radiation and chemotherapy. The tablets are equivalent to 1 mg base. The company received final approval following the expiration of Roche’s patent on December 28, 2007. (Source: Barr Labs, January 2, 2008.) Micafungin (Mycamine) for Candidemia Astellas Pharma, Inc., has announced the FDA’s approval of its supplemental New Drug Application (sNDA) for the use of micafungin sodium (Mycamine for Injection) in the treatment of candidemia, acute disseminated candidiasis, candidal peritonitis, and abscesses. Micafungin was approved in 2005 for the treatment of patients with esophageal candidiasis, and it is the only echinocandin approved for the prevention of candidal infections in patients undergoing hematopoietic stem cell transplantation. Candidemia is a fungal infection that causes bloodstream infection with the potential to spread to another part of the body. According to the Centers for Disease Control (CDC), it is the fourth most common bloodstream infection among hospitalized patients in the U.S. Micafungin inhibits an enzyme essential for fungal synthesis in the cell wall, and it is lethal to Candida. Isolated cases of anaphylaxis and anaphylactoid reactions, including shock, have been reported. Micafungin is available in two vial sizes, 50 mg and 100 mg. (Source: Wire services, Astellas, January 23, 2008.) Topical Patch for Pain (Flector) Alphapharma’s Flector patch has been approved as a topical therapy for acute pain caused by minor strains, sprains, and contusions. The patch, available by prescription, measures about 4 inches x 5.5 inches and is applied directly to intact skin at the site of pain. Each patch contains 180 mg of diclofenac epolamine. (Source: www.flectorpatch.com, January 23, 2008.) Synthetic Starch (Voluven) Controls Blood Loss The FDA has approved an intravenous (IV) starch solution (Voluven, Fresenius Kabi) that prevents and treats a loss of blood volume during and after surgery. Significant blood losses can cause a rapid drop in the volume of red blood cells (RBCs) and plasma. This can lead to shock, which can be fatal. Blood volume expanders restore some of the lost volume so that the remaining RBCs can continue to deliver oxygen to the tissues. Voluven is not recommended for patients receiving dialysis or for those with abnormal sensitivity to the synthetic starch in the product, fluid overload, kidney failure not related to low blood volume, intracranial bleeding, or increased blood levels of sodium or chloride. A postmarketing clinical trial of NEW INDICATIONS Thyrotropin Alfa (Thyrogen) For Thyroid Cancer The FDA has approved a supplemental indication for thyrotropin alfa injection (Thyrogen, Genzyme). This agent is used with radioiodine to destroy remaining thyroid tissue after surgery to remove a cancerous thyroid gland in a procedure called remnant ablation. As a recombinant form of thyroid-stimulating hormone (TSH), thyrotropin alfa enables patients to continue taking hormone supplements and to avoid the Adalimumab (Humira) For Plaque Psoriasis Abbott Laboratories has received the FDA’s approval to market adalimumab (Humira) to treat adults with moderatecontinued on page 85 76 P&T® • February 2008 • Vol. 33 No. 2 http://www.thyrogen.com http://www.flectorpatch.com

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Pharmacy & Therapeutics - February 2008 Contents Editorial Medication Errors Prescription: Washington The Language of (Forgive Us) Change, As P&T Enters the Digital Age New Drugs/Drug News/New Medical Devices Drug Forecast Use and Outcomes of Antifibrinolytic Therapy in Patients Undergoing Cardiothoracic Surgery at 20 Academic Medical Centers in the United States Evaluation of the Management of Acute Venous Thromboembolism and Its Outcomes: One Institution's Experience American Society of Hematology, 49th Annual Meeting Pharmaceutical Approval Update

Pharmacy & Therapeutics - February 2008

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