PPAR-α/δ agonist Pregnancy: US label 8.1: may cause fetal harm based on animal reproduction studies (stillbirths, reduced survival, decreased pup body weight at maternal exposures at or below human exposure at the recommended dose). Human pregnancy data are insufficient to assess drug-associated risk. Verify that females of reproductive potential are not pregnant before initiating and advise use of effective contraception.

Elafibranor

Brand names: Iqirvo

Elafibranor is an oral agent used in the treatment of primary biliary cholangitis, typically in combination with ursodeoxycholic acid or alone where that is not tolerated.

Auto-extracted from the source labelling — not yet independently clinician-verified. These values were distilled from the UK SPC (or the US label where noted) but have not had a clinician sign-off. Confirm against the current SmPC before prescribing.

Adult dose

Dose: 80 mg

Route: Oral

Frequency: Once daily, with or without food

From US prescribing information for IQIRVO (no UK SPC in the fetched bundle) — verify against UK labelling before use. Before initiating: evaluate for muscle pain or myopathy, and verify that females of reproductive potential are not pregnant. Administer at least 4 hours before or 4 hours after a bile acid sequestrant, or at as great an interval as possible. Geriatric: no dosage adjustment is necessary for patients 65 years of age and older, but closer monitoring of adverse events is recommended in patients older than 75 years because of limited clinical experience. Paediatric: safety and effectiveness have not been established in paediatric patients.

Dose auto-extracted from US FDA prescribing information (openFDA / DailyMed) — cross-check; US labelling may differ from UK — not yet clinician-verified. Always confirm against the product SmPC and your local formulary before prescribing.

Contraindications

US label section 4: None

Side effects

Weight gain
Diarrhoea, abdominal pain, nausea, vomiting, constipation
Arthralgia and muscle injury (myalgia, myopathy, rhabdomyolysis)
Fracture
Gastro-oesophageal reflux disease and dry mouth
Rash and hypersensitivity reactions

Interactions

Hormonal contraceptives — elafibranor is a weak CYP3A4 inducer and may reduce progestin and ethinyl estradiol exposure, risking contraceptive failure or breakthrough bleeding; switch to effective non-hormonal contraception or add a barrier method during treatment and for at least 3 weeks after the last dose
HMG-CoA reductase inhibitors (statins) — monitor for signs and symptoms of muscle injury
Rifampin — monitor the biochemical response (e.g. ALP and bilirubin) when rifampin is initiated during treatment
Bile acid sequestrants — administer elafibranor at least 4 hours before or 4 hours after the sequestrant, or at as great an interval as possible

Clinical monograph

How it works

It is a peroxisome proliferator-activated receptor (PPAR) agonist acting on PPAR-alpha and PPAR-delta, modulating bile acid metabolism and inflammation to improve cholestatic markers.

Prescribing in practice

Liver function and cholestatic markers should be monitored, and the drug used under specialist hepatology supervision, with attention to muscle-related and other adverse effects.
It is taken orally, usually as an add-on to ursodeoxycholic acid in patients with an inadequate response, or as monotherapy where ursodeoxycholic acid is not tolerated.
Muscle-related symptoms including myalgia have been reported, so advise patients to report significant or unexplained muscle pain or weakness.

Monitoring

Monitor liver biochemistry and cholestatic markers to assess response, and review for muscle-related and other adverse effects.

Counselling the patient

Take it as directed and continue any other prescribed liver medicines unless told otherwise.
Report unexplained muscle pain, tenderness or weakness.
Attend for blood tests as arranged to check your liver.

Evidence & guidelines

Approval is supported by a randomised controlled trial showing improvement in cholestatic markers in primary biliary cholangitis.

Reference: EASL PBC clinical practice guidelines; NICE TA evaluation; SmPC; Drug verified in RxNorm (NLM); confirm dosing against the manufacturer SPC (eMC). Verify against your local formulary and current prescribing references before prescribing. The structured dose values shown have been reviewed by a clinician. Monograph status: clinician-reviewed (2026-07-04).

Curated clinical cross-links plus same-class fallbacks.

Pathways