Elafibranor Dosage
Medically reviewed by Drugs.com. Last updated on Jul 29, 2024.
Applies to the following strengths: 80 mg
Usual Adult Dose for:
Additional dosage information:
Usual Adult Dose for Primary Biliary Cholangitis
80 mg orally once a day
Comments:
- Administer with or without food.
- Prior to treatment, evaluate patients for muscle pain or myopathy, and verify that females of reproductive potential are not pregnant.
- Limitations of use: This drug not recommended for use in patients who have or develop decompensated cirrhosis (e.g., ascites, variceal bleeding, hepatic encephalopathy).
Uses:
- As monotherapy, for the treatment of primary biliary cholangitis (PBC) in patients unable to tolerate ursodeoxycholic acid (UDCA)
- In combination with UDCA, for the treatment of PBC in patients who have had an inadequate response to UDCA
Renal Dose Adjustments
Renal dysfunction: No adjustment recommended.
Liver Dose Adjustments
Mild liver dysfunction (Child-Pugh A): No adjustment recommended.
Moderate or severe liver dysfunction (Child-Pugh B or C): Consider treatment discontinuation in patients who progress to moderate or severe dysfunction. Use is not recommended in patients who have (or develop) decompensated cirrhosis; safety has not been established.
Precautions
CONTRAINDICATIONS: None
Safety and efficacy have not been established in patients younger than 18 years.
Consult WARNINGS section for additional precautions.
Dialysis
Data not available
Other Comments
Administration advice:
- For oral use
- This drug may be administered with or without food.
- If this drug is taken concomitantly with a bile acid sequestrant, administer this drug at least 4 hours before or 4 hours after bile acid sequestrant, or as great an interval as possible.
Storage requirements:
- Store at room temperature 15C to 30C (59F to 86F) in original package to protect from moisture and light.
Monitoring:
- Hepatic: Liver function tests (at initiation and routinely thereafter); for evidence of decompensation in patients with cirrhosis (during therapy)
- Musculoskeletal: For muscle pain or myopathy (prior to initiation and periodically during therapy); bone health (during therapy per standard of care)
Patient advice:
- Read the US FDA-approved patient labeling (Medication Guide).
- Report any signs or symptoms of the following to your health care provider:
- Unexplained muscle symptoms such as pain, soreness, or weakness
- Bone fractures
- Liver injury
- Biliary obstruction
- Seek medical attention if hypersensitivity reactions, such as rash, occur.
- Female patients of childbearing potential: Use effective contraception during treatment and for 3 weeks after the last dose. Inform your health care provider of a known, suspected, or planned pregnancy.
- Breastfeeding is not recommended during treatment or for 3 weeks after the last dose.
More about elafibranor
- Check interactions
- Compare alternatives
- Side effects
- During pregnancy
- Drug class: miscellaneous metabolic agents
- En español
Patient resources
Other brands
Professional resources
Other brands
Related treatment guides
Further information
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.