Febuxostat

Elderly: no dose adjustment is required. The therapeutic target is to decrease and maintain serum uric acid below 6 mg/dL (357 micromol/L); serum uric acid can be retested after 2 weeks. Gout flare prophylaxis with an NSAID or colchicine for at least 6 months is recommended at initiation; treatment should not be started until an acute gout attack has completely subsided, but febuxostat should not be discontinued if a flare occurs during treatment. Tumour lysis syndrome: 120 mg once daily, started two days before cytotoxic therapy and continued for a minimum of 7 days (may be prolonged up to 9 days according to chemotherapy duration); these patients should be under cardiac monitoring as clinically appropriate. Hepatic impairment: recommended dose in mild hepatic impairment (gout) is 80 mg; limited information in moderate impairment; not studied in severe impairment (Child-Pugh C). Caution in patients with pre-existing major cardiovascular disease (myocardial infarction, stroke, unstable angina) — monitor regularly. Safety and efficacy in children under 18 years have not been established (no data). CROSS-CHECK FLAG: the US label in the bundle uses a lower range — 40 mg once daily starting, increased to 80 mg once daily if serum uric acid is not below 6 mg/dL after two weeks, and limited to 40 mg once daily in severe renal impairment.