ULOXORIC
- Packing10 blister packs of 10 tablets
- Shelf life36 months
- CompositionFebuxostat 120 mg
- Posology and pharmaceutical formFilm-coated tablet
Summary of product characteristic
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Indications, posology and method of administration
THERAPEUTIC INDICATIONS
Treatment of chronic hyperuricaemia in conditions where urate deposition has already occurred (including a history, or presence of, tophus and/or gouty arthritis).
Prevention and treatment of hyperuricaemia in adult patients undergoing chemotherapy for haematologic malignancies at intermediate to high risk of Tumor Lysis Syndrome (TLS).
Febuxostat is indicated in adults.
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Gout
The recommended oral dose of febuxostat is 80 mg once daily without regard to food. If serum uric acid is > 6 mg/dL (357 µ mol/L) after 2 – 4 weeks, febuxostat 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
The recommended oral dose of febuxostat is 120 mg once daily without regard to food.
Febuxostat 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.
Renal impairment
The efficacy and safety have not been fully evaluated in patients with severe renal impairment (creatinine clearance < 30 mL/min).
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 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 febuxostat in children aged below the age of 18 years have not been established. No data are available.
Method of administration:
Oral use. Febuxostat tablets should be taken by mouth and can be taken with or without food.
CONTRAINDICATIONS
Hypersensitivity to the active substance or to any of the excipients.
This information is for reference only. Please read the leaflet inside.
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