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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

e days in 4.4% of patients treated with oral allopurinol alone and 6.5% of patients treated with the Elitek/oral allopurinol combination, versus 0% of patients receiving Elitek alone. Clinical TLS occurred in 3% of Elitek-treated patients, 3% of Elitek/oral allopurinol-treated patients, and 4% of oral allopurinol-treated patients.

Hypersensitivity reactions occurred in 4.3% of patients treated with Elitek alone and 1.1% of patients treated with the Elitek/oral allopurinol combination. Hypersensitivity reactions included arthralgia, injection site irritation, peripheral edema, and rash. The most common Grade 3/4 related adverse reactions regardless of relationship to study drug were sepsis (5.4% / 6.5% / 4.4%), hypophosphatemia (4.3% / 6.5% / 6.6%), anxiety (3.3% / 0% / 0%), abdominal pain (3.3% / 4.3% / 2.2%), hyperbilirubinemia (3.3% / 2.2% / 4.4%) and increased alanine aminotransferase (3.3% / 4.3% / 2.2%) in the Elitek, Elitek/oral allopurinol and oral allopurinol arms, respectively. Of note, all patients were receiving anti-cancer chemotherapy and/or biologic anti-cancer agents for their primary disease. The following serious adverse reactions occurred with a difference in incidence of greater than or equal to 2% in patients receiving Elitek compared to patients receiving oral allopurinol: pulmonary hemorrhage, respiratory failure, supraventricular arrhythmias, ischemic coronary artery disorders, and abdominal and gastrointestinal infections.

Based on the results of the above study, Elitek is now indicated at a daily dose of 0.20 mg/kg intravenously for up to 5 days for the initial management of plasma uric acid levels in adults with leukemia, lymphoma and solid tumors receiving anti-cancer therapy expected to result in tumor lysis syndrome and subsequent elevation of plasma uric acid.

About Elitek®

A recombinant urate oxidase enzyme, Elitek is the first recombinant uricolytic agent approved in the U.S. t
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SOURCE sanofi-aventis
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