elafibranor: clinical use

Prescribing considerations

• Confirm inadequate response or intolerance to UDCA and establish hepatic status before initiation.
• Assess pregnancy status where relevant and counsel about effective contraception.
• Consider baseline fracture risk and ongoing bone-health assessment.
• There are no supporting use data in people older than 80 years.

Contraindications and cautions

• Hypersensitivity to elafibranor or any tablet excipient.
• Use is not recommended in severe hepatic impairment, decompensated cirrhosis or after a previous hepatic decompensation event.
• Avoid during pregnancy and breastfeeding; concomitant fibrate use is not recommended.

Monitoring

• Assess liver biochemistry and clinical liver function before treatment and subsequently as clinically appropriate; investigate deterioration promptly.
• Check baseline creatine phosphokinase and reassess according to clinical risk or symptoms, particularly with statin use or other muscle-injury risk factors.
• Review unexplained muscle symptoms promptly and consider treatment interruption while investigated.
• Monitor bone health according to usual clinical standards.

Clinical pharmacology

Elafibranor and GFT1007 are dual PPAR-alpha/delta agonists. Elafibranor is rapidly converted to GFT1007; both are highly protein-bound, and CYP or UGT metabolism is not a major clearance pathway.

Formulation and product differences

• The UK product is a film-coated oral tablet that must be swallowed whole.
• It is supplied in a child-resistant bottle with an integrated desiccant and should remain in its original packaging.
• The product is essentially sodium-free.

Tablet

Route: Oral

Strengths: 80 mg