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ULORIC(R) (febuxostat) Demonstrated Efficacy for Management of Hyperuricemia in Patients with Gout
Date:10/17/2009

zed by attacks, or "flares," marked by intense pain, redness, inflammation and warmth in the affected joint. These symptoms are the result of an acute inflammatory response to the presence of urate crystals in the joint(s). As the disease progresses, attacks may become more frequent and patients may develop large urate crystal deposits, known as tophi, in the skin, joints and bones. Tophi can result in joint deformity.

Uric acid is an end-product created when the body breaks down naturally occurring substances called purines. Hyperuricemia occurs when either overproduction or underexcretion of uric acid or a combination of the two leads to elevated urate levels in the body. Hyperuricemia is a precursor of gout, and the risk for developing gout increases with increasing sUA.

ULORIC® is a registered trademark of Teijin Pharma Limited and used under license by Takeda Pharmaceuticals America, Inc.

Indication

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

Important Safety Information

  • 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. - NSAIDs or colchicine) upon initiation of treatment may be beneficial for up to six months.
  • Cardiovascular Events: In randomized controlled studies, there was a higher rate of cardiovascular thromboembolic events (cardiovascular deaths, non-fatal myocardial infarctions, and non-fatal strokes) in patients treated with ULORIC [0.74 per 100 P-Y (95% CI 0.36-1.37)] than allopurinol [
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SOURCE Takeda Pharmaceuticals North America, Inc.
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