Gout: Initially 80 mg once daily without regard to food. If serum uric acid is greater than 6 mg/dL (357 μmol/L) after 2-4 weeks of initial dose, the dose of 120 mg once daily may be considered. Febuxostat works sufficiently quickly to allow retesting of the serum uric acid after 2 weeks. The therapeutic target is to decrease and maintain serum uric acid below 6 mg/dL (357 μmol/L). Gout flare prophylaxis of at least 6 months is recommended.
Tumor lysis syndrome (TLS): The recommended oral dose of Febuxostat is 120 mg once daily without regard to food, should be started 2 days before start of cytotoxic therapy and continued for 7-9 days, according to chemotherapy duration.
Geriatric: No dosage adjustment necessary.
Pediatric: The safety and the efficacy of febuxostat in children aged below the age of 18 years have not been established. No data are available.
Renal Impairment: No dosage adjustments are considered necessary in patients with mild or moderate renal impairment, but the efficacy and safety have not been evaluated in those with severe renal impairment (creatinine clearance of less than 30 mL/min).
Hepatic Impairment: The recommended oral dose of Febuxostat in patients with mild hepatic impairment is 80 mg daily. Limited information is available in patients with moderate impairment. Efficacy and safety of Febuxostat has not been studied in those with severe (Child-Pugh class C) hepatic impairment.
Administration: Administer with or without meals.
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