Key facts about Elafibranor
What dosages is Elafibranor available in?
Elafibranor is available as an 80 mg oral tablet.
What is Elafibranor used for?
Elafibranor is a peroxisome proliferator-activated receptor (PPAR) agonist indicated for the treatment of primary biliary cholangitis (PBC) along with ursodeoxycholic acid (UDCA) in adults if they cannot take UDCA or UDCA did not work for them.
How does Elafibranor work?
Elafibranor may work by blocking the formation of bile. This may help prevent a backup of bile. Bile build up can lead to the liver damage that happens with PBC.
How do I take Elafibranor?
The recommended dosage of Elafibranor is 80 mg orally once daily with or without food.
Is it safe for me to take Elafibranor?
Elafibranor is a safe and effective treatment when used for FDA approved indications. However, like all medications, they may give you unwanted side effects. You should always discuss potential side effects with your physician to ensure the medication is suitable and right for you.
Elafibranor Common Side Effects
Common side effects of Elafibranor: Weight gain, Diarrhea, Abdominal pain, Nausea, Vomiting, Joint pain, Constipation, Muscle injury, Fracture, Indigestion, Dry mouth, Weight loss, Rash
Elafibranor Serious Side Effects
Serious side effects are rare with Elafibranor. Contact your healthcare provider immediately if you experience any of the following: Allergic reactions: skin rash, itching, hives, swelling of the face, lips, tongue, or throat Liver injury: right upper belly pain, loss of appetite, nausea, light-colored stool, dark yellow or brown urine, yellowing skin or eyes, unusual weakness or fatigue Muscle injury: unusual weakness or fatigue, muscle pain, dark yellow or brown urine, decrease in amount of urine
Effects of other drugs, drug classes and over-the-counter products on Elafibranor
The following medications may interact with Elafibranor: Hormonal Contraceptives: Switch to effective non-hormonal contraceptives or add a barrier method when using hormonal contraceptives and for at least 3 weeks after last dose. HMG-CoA Reductase Inhibitors: Monitor for signs and symptoms of muscle injury. Rifampin: Monitor the biochemical response (e.g., ALP and bilirubin) when patients initiate rifampin during Elafibranor treatment. Bile Acid Sequestrants: Administer at least 4 hours before or 4 hours after taking a bile acid binding sequestrant, or at as great an interval as possible.
Who makes Elafibranor?
Various FDA-approved generic manufacturers
Is Elafibranor safe in pregnancy?
Elafibranor can harm your unborn baby. You should not become pregnant during treatment with this medication. You should use effective birth control during treatment and for 3 weeks after the last dose of Elafibranor. Talk to your healthcare provider about birth control methods that may be right for you.













