febuxostat magnesium: clinical use

Prescribing considerations

• Use cautiously and monitor regularly after myocardial infarction, stroke, unstable angina or other major cardiovascular disease.
• Do not initiate during an unresolved acute gout attack; explain that mobilisation flares can occur.
• Assess hepatic and renal impairment; evidence is limited in severe impairment.
• Avoid during pregnancy and breastfeeding.
• Not recommended in organ-transplant recipients because clinical experience is lacking.
• Use caution with altered thyroid function and rare hereditary disorders affecting lactose handling.

Contraindications and cautions

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

Monitoring

• Check liver function before treatment and periodically according to clinical judgement.
• Monitor serum urate to assess biochemical response.
• Monitor people with pre-existing major cardiovascular disease regularly.
• Watch for rash, systemic hypersensitivity and hepatic or renal involvement.
• Consider thyroid status in existing thyroid dysfunction.

Clinical pharmacology

Febuxostat is a non-purine selective inhibitor of the oxidised and reduced forms of xanthine oxidase. It is well absorbed, highly protein-bound and extensively metabolised through glucuronidation and CYP-mediated oxidation.

Formulation and product differences

• The selected product is a film-coated tablet containing febuxostat as magnesium salts.
• It contains lactose and is described as essentially sodium-free.

Tablet

Route: Oral

Strengths: 80 mg, 120 mg