DEGOUT-40 (febuxostat) tablet for oral use INDICATIONS AND USAGE DEGOUT-40 is a xanthine oxidase (XO) inhibitor indicated for the chronic management of hyperuricemia in patients with gout. DEGOUT-40 is not recommended for the treatment of asymptomatic hyperuricemia. DOSAGE AND ADMINISTRATION DEGOUT-40 is recommended at 40 mg or 80 mg once daily. The recommended starting dose of DEGOUT-40 is 40 mg once daily. For patients who do not achieve a serum uric acid (sUA) less than 6 mg per dL after 2 weeks with 40 mg, DEGOUT-40 80 mg is recommended. DEGOUT-40 can be administered without regard to food or antacid use. No dose adjustment is necessary when administering DEGOUT-40 to patients with mild to moderate renal or hepatic impairment. DOSAGE FORMS AND STRENGTHS Tablet: 40 mg, 80 mg. CONTRAINDICATIONS DEGOUT-40 is contraindicated in patients being treated with azathioprine, mercaptopurine, or theophylline. WARNINGS AND PRECAUTIONS Gout Flare: An increase in gout flares is frequently observed during initiation of anti-hyperuricemic agents, including DEGOUT-40. If a gout flare occurs during treatment, DEGOUT-40 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. Cardiovascular Events: A higher rate of cardiovascular thromboembolic events was observed in patients treated with DEGOUT-40 than allopurinol in clinical trials. Monitor for signs and symptoms of MI and stroke. Liver Enzyme Elevation: Transaminase elevations have been observed in DEGOUT-40-treated patients. Monitor liver function tests periodically. ADVERSE REACTIONS Adverse reactions occurring in at least 1% of DEGOUT-40-treated patients, and, at least 0.5% greater than placebo, are liver function abnormalities, nausea, arthralgia, and rash. DRUG INTERACTIONS Concomitant administration of DEGOUT-40 with XO substrate drugs, azathioprine, mercaptopurine, or theophylline could increase plasma concentrations of these drugs resulting in severe toxicity. USE IN SPECIFIC POPULATIONS There is insufficient data in patients with severe renal impairment. No studies have been conducted in patients with severe hepatic impairment. Caution should be exercised in these patients. No studies have been conducted in patients with secondary hyperuricemia (including patients being treated for Lesch-Nyhan syndrome or malignant disease, or in organ transplant recipients); therefore, DEGOUT-40 is not recommended for use in these patients.
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