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FDA Approves Elitek(R) (rasburicase) for Management of Plasma Uric Acid Levels in Adults with Leukemia, Lymphoma, and Solid Tumors Receiving Anti-Cancer Therapy
Date:10/16/2009

o maintain PUA levels in patients receiving anti-cancer therapy. Elitek rapidly catabolizes circulating uric acid into allantoin, a highly soluble by-product that is easily excreted by the kidneys. Elitek reduces circulating uric acid levels as soon as 4 hours after the first dose. Elitek was initially approved by the U.S. FDA in 2002 to manage PUA levels in pediatric patients receiving anti-cancer treatment and at risk for TLS. Visit www.elitekinfo.com for more information about Elitek. Elitek® is also commercially available under the brand name of Fasturtec® outside the United States.

Elitek is indicated for the initial management of plasma uric acid levels in pediatric and adult patients with leukemia, lymphoma, and solid tumor malignancies who are receiving anti-cancer therapy expected to result in tumor lysis syndrome and subsequent elevation of plasma uric acid. Elitek is indicated for only a single course of treatment.

IMPORTANT SAFETY INFORMATION

Anaphylaxis: ELITEK can cause severe hypersensitivity reactions including anaphylaxis. Immediately and permanently discontinue ELITEK in patients who experience a serious hypersensitivity reaction.

Hemolysis: Do not administer ELITEK to patients with glucose-6-phosphate dehydrogenase (G6PD) deficiency. Immediately and permanently discontinue ELITEK in patients developing hemolysis. Screen patients at higher risk for G6PD deficiency (e.g., patients of African or Mediterranean ancestry) prior to starting ELITEK.

Methemoglobinemia: ELITEK can result in methemoglobinemia in some patients. Immediately and permanently discontinue ELITEK in patients developing methemoglobinemia.

Interference with Uric Acid Measurements: ELITEK enzymatically degrades uric acid in blood samples left at room temperature. Collect blood samples in pre-chilled tubes containing h
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SOURCE sanofi-aventis
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