febuxostat: clinical use

Prescribing considerations

• Do not initiate during an unresolved acute gout attack.
• Use cautiously and monitor regularly in pre-existing major cardiovascular disease, especially during initiation or with a high crystal or tophus burden.
• Safety and efficacy are not fully evaluated in severe renal impairment or severe hepatic impairment.
• Use is not recommended in organ-transplant recipients because of insufficient experience.
• Exercise caution with altered thyroid function and previous serious allopurinol hypersensitivity.

Contraindications and cautions

• Hypersensitivity to febuxostat or any product excipient.
• Do not restart after a serious febuxostat hypersensitivity reaction, including Stevens–Johnson syndrome or anaphylaxis.

Monitoring

• Measure serum urate to assess biochemical response.
• Check liver function before treatment and subsequently according to clinical judgement.
• Monitor patients with major cardiovascular disease regularly.
• Educate patients about early hypersensitivity symptoms and stop treatment immediately if a serious reaction occurs.

Clinical pharmacology

Febuxostat is a potent, non-purine selective inhibitor of both oxidised and reduced xanthine oxidase, reducing conversion of hypoxanthine and xanthine into uric acid.

Formulation and product differences

• The selected product is a film-coated tablet containing lactose and is essentially sodium-free.
• Its score line facilitates breaking for swallowing but does not divide the tablet into equal portions.

Tablet

Route: Oral

Strengths: 80 mg, 120 mg