Elafibranor Dosage

Medically reviewed by Drugs.com. Last updated on Jul 29, 2024.

Usual Adult Dose for Primary Biliary Cholangitis

80 mg orally once a day

Comments:

• Administer with or without food.
• Prior to treatment: Evaluate for muscle pain or myopathy, and verify that females of reproductive potential are not pregnant.
• Limitations of use: This drug is not recommended for use in patients who have or develop decompensated cirrhosis (e.g., ascites, variceal bleeding, hepatic encephalopathy).

• 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.

Comment:

• Use is not recommended in patients who have (or develop) decompensated cirrhosis; safety has not been established.

Precautions

US FDA requires a medication guide to assure safe use. For additional information visit:
www.fda.gov/drugs/drug-safety-and-availability/medication-guides

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.
• During concomitant use with a bile acid sequestrant, administer this drug at least 4 hours before or 4 hours after the bile acid sequestrant, or as great an interval as possible.

• Store at room temperature 15C to 30C (59F to 86F) in original package to protect from moisture and light.

• Report pregnancies to Ipsen Pharmaceuticals, Inc. Adverse Event reporting line at 1-855-463-5127 and at https://www.ipsen.com/contact-us/

• 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)

• 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.

See also:

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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