Pharmacy & Therapeutics - April 2008 - (Page 203) NEW DRUGS NEW DRUGS Desvenlafaxine (Pristiq) For Major Depressive Disorder The Food and Drug Administration (FDA) has approved desvenlafaxine (Pristiq, Wyeth), a once-daily serotonin– norepinephrine reuptake inhibitor (SNRI) for adults with major depressive disorder (MDD). Because titration is not required for the 50-mg dose, physicians can start patients at the recommended therapeutic dose. The drug delivers the major active metabolite of venlafaxine HCl (Effexor) in its active state without going through the cytochrome P450 (CYP 2D6) metabolic pathway. Desvenlafaxine is discussed in detail in this month’s Pharmaceutical Approval Update on page 233. (Source: Wyeth, February 29, 2008.) DRUG NEWS treated with chlorambucil (Leukeran, GlaxoSmithKline). The FDA has granted orphan drug status for this drug for the treatment of CLL. The orphan drug designation will provide marketing exclusivity for this indication until March 2015. (Source: Cephalon, March 20, 2008.) ment of two cryopyrin-associated periodic syndromes: familial cold auto inflammatory syndrome, and Muckle– Wells syndrome. Symptoms of both disorders include joint pain, rash, or skin lesions; fever and chills, eye redness or pain, and fatigue; Muckle–Wells syndrome is associated with more severe inflammation, sometimes including hearing loss, deafness, and amyloidosis. For more information about Rilonacept, please see this month’s Pharmaceutical Approval Update on page 236.) (Source: FDA, February 28, 2008.) Levoleucovorin as Rescue Therapy Levoleucovorin (L-leucovorin) for injection (Spectrum) has been approved as rescue therapy in patients with osteosarcoma who are receiving high-dose methotrexate and for reducing the toxic effects of inadvertent overdosage with methotrexate or other folic acid antagonists. Leucovorin calcium, a 50:50 racemic mixture of the L- and D-enantiomers of leucovorin, has been sold in the U.S. for many years. Only the L-isomer of leucovorin has biological activity. Because levoleucovorin consists of just the active isomer, patients need only half of the amount used in standard leucovorin therapy. This product will be available in vials containing 50 mg of lyophilized powder. Levoleucovorin will be more expensive than the older products, and it is not considered a generic drug. FDA-approved labeling is not yet available. (Sources: Spectrum, March 7, 2008; American Society of Health-System Pharmacists, March 11, 2008.) Dextroamphetamine Oral Solution (Liquadd) for ADHD Auriga Laboratories, Inc., has announced the approval of an easy-to-swallow oral solution of dextroamphetamine sulfate (Liquadd) at a dose of 5 mg/5 mL for patients with Attention Deficit/Hyperactivity Disorder (ADHD). Liquadd is not intended for patients with a histor y of drug abuse, and it should not be used during or within 14 days after a person takes a monoamine oxidase inhibitor because of the potential for a hypertensive crisis. Liquadd is contraindicated for patients with glaucoma, advanced arteriosclerosis, symptomatic cardiovascular disease, moderate to severe hypertension, hyperthyroidism, or hypersensitivity to sympathomimetic amines or for anyone in an agitated state. (Sources: Auriga, March 10, 2008; www.medicalnewstoday.com.) Sevelamer (Renvela) For Dialysis Patients The phosphate binder sevelamer carbonate (Renvela, Genzyme) has been launched for dialysis patients in the U.S. The company hopes to expand the labeling to include chronic kidney disease patients with hyperphosphatemia who are not on dialysis. Genzyme also plans to file for approval of the powder formulation in the U.S. Renvela is a next-generation version of sevelamer HCl (Renagel), but it also contains a carbonate buffer. It is the only phosphate binder that does not contain calcium or metals. Controlling serum phosphorus is important in the care of dialysis patients; elevated phosphorus levels are associated with an increased risk of cardiovascular disease. (Sources: Genzyme, March 6, 2008; www.renvela.com.) Bendamustine (Treanda) For Chronic Lymphocytic Leukemia Bendamustine HCl (Treanda for Injection, Cephalon) has been approved for patients with chronic lymphocytic leukemia (CLL). In a pivotal study, patients who received bendamustine had better clinical outcomes and longer progression-free survival compared with patients Synthetic Anthracycline (Amrubicin) For Small-Cell Lung Cancer Amrubicin (Celgene) has received an orphan drug designation for the treatment of small-cell lung cancer. This thirdgeneration analogue is a potent topoisomerase II inhibitor. It is being studied as a single agent and in combination with anticancer therapies for solid tumors, Rilonacept (Arcalyst) For Inflammatory Syndromes Rilonacept (Arcalyst, Regeneron) has been approved for the long-term treat- Vol. 33 No. 4 • April 2008 • P&T® 203 http://www.medicalnewstoday.com http://www.renvela.com
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