Recommended Dose: For the treatment of hyperuricemia in patients with gout, FEBUXOSTAT is recommended at 40 mg or 80 mg once daily.
The recommended starting dose of FEBUXOSTAT is 40 mg once daily. For patients who do not achieve a serum acid (sUA) less than 6 mg/dL after two weeks with 40 mg, FEBUXOSTAT 80 mg is recommended.
FEBUXOSTAT can be taken without regards to food or antacid use.
Special Populations: No dose adjustment is necessary when administering FEBUXOSTAT in patients with mild or moderate renal impairment. The recommended starting dose of FEBUXOSTAT is 40 mg once daily. For patients who do not achieve a sUA less than 6 mg/dL after two weeks with 40 mg, FEBUXOSTAT 80 mg is recommended.
The dose of FEBUXOSTAT is limited to 40 mg once daily in patients with severe renal impairment (see Precautions and Pharmacology under Actions).
Uric Acid Level: Testing for the target serum uric acid level of less than 6 mg/dL may be performed as early as two weeks after initiating FEBUXOSTAT therapy.
Gout Flares: Gout flares may occur after initiation of FEBUXOSTAT due to changing serum uric acid levels resulting in mobilization of urate from tissue deposits. Flare prophylaxis with a non-steroidal anti-inflammatory drug (NSAID) or colchicine is recommended upon initiation of FEBUXOSTAT.
If a gout flares occurs during FEBUXOSTAT treatment, FEBUXOSTAT need not to be discontinued. The gout flare should be managed concurrently as appropriate for the individual patient.
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