Febuxostat-40 Tablets

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.