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Posology: Gout: The recommended oral dose of Feburic is 80 mg once daily without regard to food. If serum uric acid is > 6 mg/dL (357 μmol/L) after 2-4 weeks, Feburic 120 mg once daily may be considered.
Feburic 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 (357μmol/L).
Gout flare prophylaxis of at least 6 months is recommended (see Precautions).
Tumor Lysis Syndrome: The recommended oral dose of Feburic is 120 mg once daily without regard to food.
Feburic should be started two days before the beginning of cytotoxic therapy and continued for a minimum of 7 days; however treatment may be prolonged up to 9 days according to chemotherapy duration as per clinical judgment.
Elderly: No dose adjustment is required in the elderly (see Pharmacology: Pharmacokinetics under Actions).
Renal impairment: The efficacy and safety have not been fully evaluated in patients with severe renal impairment (creatinine clearance < 30 mL/min, see Pharmacology: Pharmacokinetics under Actions).
No dose adjustment is necessary in patients with mild or moderate renal impairment.
Hepatic impairment: The efficacy and safety of febuxostat has not been studied in patients with severe hepatic impairment (Child Pugh Class C).
Gout: The recommended dose in patients with mild hepatic impairment is 80 mg. Limited information is available in patients with moderate hepatic impairment.
Tumour Lysis Syndrome: in the pivotal Phase III trial (FLORENCE) only subjects with severe hepatic insufficiency were excluded from trial participation. No dose adjustment was required for enrolled patients on the basis of hepatic function.
Paediatric population: The safety and the efficacy of Feburic in children below the age of 18 years have not been established. No data are available.
Method of administration: Oral use
Feburic should be taken by mouth and can be taken with or without food.
