Febuxostat

• Recommended dosage is 40 mg or 80 mg once daily. The recommended starting dosage is 40 mg once daily. For patients who do not achieve a serum uric acid (sUA) less than 6 mg/dL after 2 weeks, the recommended dosage is 80 mg once daily. (2.1)

• Patients with severe renal impairment: Limit the dosage to 40 mg once daily. (2.2, 8.6)

• Flare prophylaxis is recommended upon initiation of febuxostat tablets. (2.4)

• Can be administered without regard to food or antacid use. (2.1)

• 40 mg tablets, round, biconvex, green colored, film-coated tablets with ‘721’ debossed on one side and plain on other side.
• 80 mg tablets, oval, biconvex, green colored, film-coated tablets with ‘722’ debossed on one side and plain on other side.

• Patients with severe hepatic impairment: No studies have been conducted in this patient population. Caution should be exercised in these patients. (8.7)

• Patients with secondary hyperuricemia (including patients being treated for Lesch-Nyhan syndrome or malignant disease, or in organ transplant recipients): Febuxostat is not recommended for use as no studies have been conducted in this patient population. (8.8)