Drug Topics - December 10, 2007 - (Page 18)

18 DRUG TOPICS DECEMBER 10, 2007 www.drugtopics.com Rx Care This breast cancer drug is first in new class of chemo agents Heidi Belden, Pharm.D. included 752 patients. Results showed a statistically significant improvement in progression-free survival. “Ixabepilone will more than likely be used as a single agent in metastatic breast cancer patients who have failed other standard chemotherapy agents as salvage therapy,” Michaud said. She believes that although the drug can be used with capecitabine, the combination is quite toxic and may not be appropriate for the majority of patients. Patients with hepatic impairment comprise one group at increased risk for developing neutropenia and other serious adverse reactions. According to the prescribing information, the combination of ixabepilone and capecitabine is contraindicated—due to increased risk of toxicity and neutropeniarelated death—in patients with AST or ALT >2.5 times the upper limit of normal (ULN) or with bilirubin > one time the ULN. Caution should be used with ixabepilone as monotherapy in patients with AST or ALT levels > five times ULN; the patients should receive a reduced dose depending on the degree of hepatic impairment. Peripheral neuropathy is characterized as a common side effect of ixabepilone, occurring in 67% of patients on combination treatment and 63% on monotherapy. According to the manufacturer, most cases emerge early in treatment—within the first three cycles—and can be managed through dose reductions, delays, and treatment discontinuation. Patients with diabetes seem to be at an increased risk of developing peripheral neuropathy. Patients receiving ixabepilone should also be monitored for myelosuppression. FreIxempra TIPS TO REMEMBER quent peripheral blood cell counts are rec2 ommended, and patients who experience seThe recommended dose of Ixempra is 40 mg/m infused intravenously over three hours every three weeks. vere neutropenia or thrombocytopenia should have their doses reduced. In addition, Premedication with an H1 and H2 antagonist about one hour caution should be exercised in patients with prior to Ixempra infusion is recommended. Patients who have experienced a prior hypersensitivity reaction to Ixempra should a history of cardiac disease due to reports of also be premedicated with a corticosteroid. myocardial ischemia, ventricular dysfunction, and supraventricular arrhythmia. Frequent peripheral blood cell counts are recommended for patients receiving Ixempra. The wholesale list price of Ixempra (see http://www.ixempra.com) per cycle Ixempra should not be used in patients with baseline neuis $4,610, according to BMS, or between trophil count 1,500 cells/mm3 or a platelet count 100,000 cells/mm3. $18,440 and $23,050 per treatment course. DT reast cancer patients who have progressed through currently available chemotherapy will now have another treatment option at their disposal. Ixabepilone (Ixempra), from Bristol-Myers Squibb, was recently approved by the Food & Drug Administration for this subset of patients, both as monotherapy and in combination with capecitabine (Xeloda, Roche). Specifically, the new entity is indicated in patients with metastatic or locally advanced breast cancer. If it is to be used as monotherapy, patients should be resistant to anthracyclines, taxanes, and capecitabine. As a combination treatment with capecitabine, ixabepilone is indicated for breast cancer resistant to both an anthracycline and a taxane. “Ixabepilone is the first in a new class of chemotherapy agents called epothilones,” said Laura Boehnke Michaud, Pharm.D., BCOP FASHP clinical pharmacy , , specialist in breast oncology at the University of Texas M. D. Anderson Cancer Center. “They function similarly to the taxanes, binding to beta-tubulin, preventing microtubule depolymerization, preventing mitosis, and eventually leading to apoptosis,” she explained. “They bind in a unique manner to beta-tubulin and appear to be active in taxane-resistant tumor cell lines, tumor xenografts, and in patients with pretreated metastatic breast cancer.” Results of a phase II trial that led to the approval of the drug as a monotherapy involved 126 patients with resistant breast cancer. According to BMS, there was an objective partial response in 12.4% of 113 patients who were evaluated. A phase III trial evaluating safety and efficacy of the drug as a combination treatment with capecitabine B http://www.drugtopics.com http://www.ixempra.com

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Drug Topics - December 10, 2007 Latebreakers Latebreakers in Depth Letters Health-System Edition - Cover Story Clinical Practice Professional Practice Special Report Technology Community Practice Unraveling Medicare 150 Years of American Pharmacy Rx Care In the Pipeline Cover Story: Fair or foul? Self-Care Chains and Business Government and Law Continuing Education: Natural Medicines for Bone Health New Products Advertisers Index Classified Viewpoint

Drug Topics - December 10, 2007

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