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FDA Approves ULORIC(R) (febuxostat) for the Chronic Management of Hyperuricemia in Patients with Gout
Date:2/13/2009

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ULORIC works by blocking the enzyme xanthine oxidase. Xanthine oxidase is responsible for the breakdown of the purine base, hypoxanthine, to xanthine, and then to uric acid. By blocking this enzyme, ULORIC helps prevent uric acid production, thereby lowering elevated levels of serum uric acid.

Important Safety and Other Information

ULORIC is a xanthine oxidase inhibitor indicated for the chronic management of hyperuricemia in patients with gout. ULORIC is not recommended for the treatment of asymptomatic hyperuricemia.

ULORIC is contraindicated in patients being treated with azathioprine, mercaptopurine, or theophylline. An increase in gout flares is frequently observed during initiation of anti-hyperuricemic

agents, including ULORIC. If a gout flare occurs during treatment, ULORIC need not be discontinued. Prophylactic therapy (i.e., non-steroidal anti-inflammatory drug (NSAID) or colchicine upon initiation of treatment) may be beneficial for up to six months. A higher rate of cardiovascular thromboembolic events was observed in patients treated with ULORIC (0.74 per 100 patient-years) than allopurinol (0.60 per 100 patient-years) in clinical trials. A causal relationship with ULORIC has not been established. Monitor for signs and symptoms of myocardial infarction (MI) and stroke. Transaminase elevations have been observed in ULORIC-treated patients. No dose-effect relationship for these transaminase elevations was noted. Monitor liver function tests periodically. Adverse reactions occurring in at least 1 percent of ULORIC- treated patients, and, at least 0.5 percent greater than placebo, are liver function abnormalities, nausea, arthralgia, and rash.

Please see complete Prescribing Information and visit the ULORIC Web site at www.uloric.com.

Takeda Pharmaceuticals North America, Inc. and Takeda
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SOURCE Takeda Pharmaceutical Company Limited
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