elafibranor at a glance
Medicine class
Dual PPAR-alpha/delta agonist
Licensed use
Primary biliary cholangitis in adults after inadequate response or intolerance to UDCA
Food
May be taken with or without food
Tablet handling
Swallow whole with water; do not crush, chew or split
Monitoring
Liver function and creatine phosphokinase are assessed before treatment and subsequently as clinically appropriate
What is elafibranor used for?
Elafibranor is licensed for adults with primary biliary cholangitis.
Used with UDCA when UDCA alone has not worked well enough.
Used alone when UDCA cannot be tolerated.
How does elafibranor work?
Elafibranor and its active metabolite activate PPAR-alpha and PPAR-delta receptors. This reduces bile-acid production and toxicity, supports bile transport and affects inflammatory pathways, helping to lessen cholestatic liver injury.
elafibranor preparations and strengths
Tablet
Route: Oral
Strengths: 80 mg
How to take elafibranor
Follow the specialist's instructions. Take the tablet with or without food and swallow it whole with water.
Do not crush, chew or split the tablet.
Do not stop treatment without discussing it with the prescriber.
elafibranor side effects
Common or expected effects
- Abdominal pain
- Diarrhoea
- Nausea or vomiting
- Headache
- Constipation
- Gallstones
- Muscle pain or increased creatine phosphokinase
Get urgent medical advice
- Severe hypersensitivity reaction
- Unexplained muscle pain, soreness or weakness suggesting muscle injury
- Significant deterioration in liver blood tests or liver function
elafibranor in pregnancy
Elafibranor is not recommended during pregnancy because animal studies indicate potential fetal harm and human data are limited. Pregnancy status should be checked before treatment where relevant. Effective contraception is required during treatment and for three weeks after the final tablet. Contact the prescriber promptly if pregnancy occurs or is planned.
elafibranor while breastfeeding
Elafibranor should not be used while breastfeeding or for three weeks after the final tablet. It is unknown whether elafibranor or its metabolites enter human milk, so risk to the infant cannot be excluded.
elafibranor interactions
The full medication list should be reviewed.
Fibrates
Combined use is not recommended because both act through related pathways and experience with the combination is limited.
Statins
A pharmacokinetic interaction was not demonstrated, but clinicians should remain alert to muscle symptoms and consider creatine phosphokinase monitoring because muscle injury has occurred.
Common questions about elafibranor
Answers are fully visible for fast scanning and source review.
What is elafibranor used for?
It treats primary biliary cholangitis in adults whose response to UDCA is inadequate or who cannot tolerate UDCA.
Can it be taken with ursodeoxycholic acid?
Yes. It can be used with UDCA when UDCA alone has not produced an adequate response.
Can it be taken with food?
Sources
These sources were used to prepare and review this medicine page.
Prepared and reviewed by the iatroX editorial team.