Rasburicase (Elitek, Sanofi-Aventis U.S.) has been approved for the initial management of plasma uric acid levels in adult patients with leukemia, lymphoma, and solid tumor malignancies who are receiving anti-cancer therapy that is expected to cause tumor lysis syndrome (TLS) and elevations of plasma uric acid.
Rasburicase was first approved in 2002 to manage plasma uric acid levels in pediatric patients receiving anti-cancer treatment and at risk for TLS. The new approval was based on pivotal phase 3 trial results showing that the drug significantly reduced PUA levels when compared to the current standard of care (oral allopurinol) in adults with hematological cancers at risk for TLS.
Based on the results of the study, rasburicase is now indicated at a daily dose of 0.20 mg/kg intravenously for up to five days. This is the first recombinant uricolytic FDA-approved agent in the U.S. for maintaining uric acid levels in patients undergoing cancer treatment. The drug rapidly catabolizes circulating uric acid into allantoin, which can be easily excreted by the kidneys in as little as four hours after the first dose.
Sources: FDA, www.elitekinfo.com, October 16, 2009