Drug Topics - October 22, 2007 - (Page 10)

10 DRUG TOPICS OCTOBER 22, 2007 www.drugtopics.com Rx Care FDA approves dexrazoxane for treatment of extravasation Julio Fernandez, Pharm.D. he Food & Drug Administration has approved a new drug, Totect (dexrazoxane, TopoTarget), indicated for the treatment of extravasations resulting from intravenous (IV) anthracycline chemotherapy. Extravasation reactions, which can lead to tissue necrosis, severe pain, and ulceration of the skin and underlying tissue, can have a tremendous impact on healthcare costs, as tissue damage may require surgery and skin grafting. Since “Our role as pharmacists the 1970s, many treatis to educate the physicians ments and antidotes, e.g., topical cooling, with regard to the use saline lavage, and diof this medication.” methyl sulfoxide, have Scott Soefje, Pharm.D., BCOP been studied for managing the condition. “This is an excellent advancement in the treatment of anthracycline extravasations. Up to now there has not been a treatment with a great deal of efficacy,” said Lisa Schulmeister, R.N., M.N., APRN-BC, OCN, FAAN, an oncology nursing consultant in New Orleans. The mechanism of action by which dexrazoxane diminishes tissue damage is unknown. “There is evidence suggesting that it reversibly inhibits topoisomerase II, inactivating the anthracycline,” added Schulmeister. The safety and efficacy of dexrazoxane were studied in two open-label clinical studies in 57 evaluable patients who developed extravasation symptoms: pain, burning, swelling, and/or redness near the infusion site after receiving IV anthracycline. “In the studies, the majority of patients did not require any surgery following extravasation,” said Melissa Butler, Pharm.D., clinical pharmacy specialist– T oncology, Orlando Regional Medical Center/ M. D. Anderson Cancer Center. Role as pharmacists “Our role as pharmacists is to educate the physicians with regard to the use of this medication. Some physicians may try to use the drug to treat every extravasation. We need to hold Totect for use with anthracycline extravasations,” noted Scott Soefje, Pharm.D, BCOP, director of pharmacy operations at Cancer Therapy & Research Center, San Antonio. Dexrazoxane is not on the formulary at Soefje’s practice site, but it will be considered, he said, if it proves an effective alternative. Extravasation treatment may cause a delay in the administration of chemotherapeutic regimens, Schulmeister noted. However, he said, “Totect has very few side effects and is efficacious, which allows patients to continue their chemotherapy treatments.” The most frequently reported adverse events in the clinical trials were nausea (43%), pyrexia (21%), and vomiting (19%). The manufacturer recommends hematologic monitoring for patients receiving dexrazoxane because of its association with leucopenia, neutropenia, and thrombocytopenia. Once daily According to product labeling, dexrazoxane should be administered intravenously once daily for three consecutive days. Previously, Soefje noted, treatment had to be administered at the extravasation site. Individual dosage is based on the patient’s body surface area and should be infused over one to two hours in a large vein in an area other than the one affected by the extravasation. Totect is supplied in a package of 10 single-use vials of 500-mg dexrazoxane for injection and 10 vials of diluent. Each vial of dexrazoxane for injection must be mixed with 50 mL of the TIPS TO REMEMBER Totect supplied diluent, and the total dose needs to be further diluted in one liter of 0.9% Dimethylsulfoxide (DMSO) should not be used in patients who are receiving dexrazoxane to treat anthracycline-induced exNaCl. The manufacturer recommends utitravasation. lizing the mixed solution within two hours The indicated dose should be infused in a large-caliber vein in of preparation because there are no preseran area other than the one affected by extravasation. vatives. “Totect will become the standard The first infusion should be administered as soon as possible of practice for treatment of anthracycline and within the first six hours after extravasation. extravasation,” concluded Butler. THE AUTHOR is a writer based in New Jersey. http://www.drugtopics.com

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Drug Topics - October 22, 2007 Contents Latebreakers Legislative Victory Builds Momentum for Pharmacy Month Letters Health-System Edition R.Ph.s Brace for Payment Denial for Hospital-Acquired Conditions Topical Human Thrombin Helps Arrest Bleeding FDA Panels Fail to Set Target Levels for Renal Patients’ Hemoglobin Warning Letters Raise Patient Safety Concerns for Fentora Ending/Reversing Weight Gain Man Given Fatal Drug Overdose at Staten Island Hospital Pharmacists Playing More Important Role in Dialysis Treatment AHA President R.Ph.'s Here's How You Can Increase Your Value Premier Launches Comprehensive Quality Improvement Project FDA Approves Dexrazoxane for Treatment of Extravasation New Federal, State Reforms to Ease Disaster Relief Kinks 150 Years of American Pharmacy Ten Tips for MTM Success Independent Superstars: The Ones to Watch The New Dynamic Duo A Parkinson's Disease Primer Classified New Products Advertisers Index Viewpoint

Drug Topics - October 22, 2007

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