Chronic management of hyperuricemia in adult patients with gout who have an inadequate response to a maximally titrated dose of allopurinol, who are intolerant to allopurinol, or for whom treatment with allopurinol is not advisable.

Initial dose: 40 mg PO qDay May increase to 80 mg PO qDay after 2 wk if serum uric acid <6 mg/dL is not achieved.

• Mild to moderate (CrCl 30-89 mL/min): No dosage adjustment necessary.
• Severe (CrCl <30 mL/min): Not to exceed 40 mg/day.

• Mild to moderate (Child-Pugh class A or B): Dosage adjustment not necessary.
• Severe (CrCl <30 mL/min): Not to exceed 40 mg/day.
• Hepatic impairment.

Upon initiation, recommend for flare prophylaxis with a nonsteroidal anti- inflammatory drug (NSAID) or colchicine Prophylactic therapy may be beneficial for up to 6 months If a gout flare occurs, managed gout flare concurrently; treatment does not need to be discontinued.

Febuxostat contraindications include patients treated with azathioprine or mercaptopurine. Xanthine oxidase inhibition increases concentrations of azathioprine and mercaptopurine, resulting in serious toxicity such as myelosuppression. The formulation of febuxostat contains lactose as an excipient. Use with caution in lactose intolerant patients.