filgotinib maleate: clinical use

Prescribing considerations

• Initiation should be by a clinician experienced in rheumatoid arthritis or ulcerative colitis.
• Assess infection, tuberculosis, viral hepatitis, cardiovascular, thromboembolic and malignancy risks before treatment.
• In people aged 65 or older, long-term current or former smokers, and those with cardiovascular or malignancy risk factors, use only when no suitable alternative is available.
• Review immunisations before treatment and consider prophylactic shingles vaccination.
• Renal and hepatic function affect suitability; end-stage renal disease and severe hepatic impairment have not been studied.

Contraindications and cautions

• Hypersensitivity to filgotinib or an excipient
• Active tuberculosis
• Active serious infection
• Pregnancy

Monitoring

• Check full blood count before treatment and subsequently as clinically indicated; interrupt or avoid initiation at the product-information thresholds.
• Check lipid profile after treatment begins and subsequently according to hyperlipidaemia guidance.
• Monitor for infection, tuberculosis and viral hepatitis reactivation.
• Reassess venous-thromboembolism risk periodically.
• Perform periodic skin examinations, particularly when skin-cancer risk is increased.

Clinical pharmacology

Filgotinib is an ATP-competitive, reversible, JAK1-preferential inhibitor. It is mainly metabolised by CES2 to the less potent active metabolite GS-829845; both contribute to activity, and elimination is predominantly urinary.

Formulation and product differences

• Available film-coated tablet strengths share the same formulation type and contain lactose but differ in size and imprint.
• Tablets should be swallowed whole and stored tightly closed in their original moisture-protective container.

Tablet

Route: Oral

Strengths: 100 mg, 200 mg