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Rasburicase indication expanded.

Rasburicase, a recombinant uricolytic agent, has a new indication for the initial management of plasma uric acid levels in adults with leukemia, lymphoma, and solid tumor malignancies "who are receiving [anticancer] therapy expected to result in tumor lysis and subsequent elevation of plasma uric acid."

The drug was approved in 2002 for the same indication in pediatric patients. It is marketed as Elitek by Sanofi-Aventis U.S. The recommended dosage is 0.2 mg/kg as a 30-minute intravenous infusion daily for up to 5 days.

The label includes a summary of an open-label study of 275 adults with leukemia, lymphoma, and solid tumor malignancies who were at risk for hyperuricemia and tumor lysis syndrome. They were randomized to rasburicase, rasburicase followed by oral allopurinol, or oral allopurinol alone. In the study, 87% of those on rasburicase alone had plasma uric acid levels at or below 7.5 mg/dL from day 3 of treatment to day 7 after starting treatment, the main end point. The response rate was 78% for the combination, and 66% for allopurinol alone, a significant difference.
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Title Annotation:NEWS FROM THE FDA
Publication:Internal Medicine News
Article Type:Brief article
Date:Dec 1, 2009
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