Elafibranor is used treat a certain type of liver disease (primary biliary cholangitis - PBC). PBC causes too much bile to stay in the liver, which can damage the liver. Elafibranor may work by decreasing the amount of bile that your liver makes.

Read the Medication Guide provided by your pharmacist before you start taking elafibranor and each time you get a refill. If you have any questions, ask your doctor or pharmacist.

Take this medication by mouth with or without food as directed by your doctor, usually once daily.

If you also take certain drugs to lower your cholesterol (bile acid-binding resins such as cholestyramine or colestipol), take elafibranor at least 4 hours before or at least 4 hours after taking these medications. These products can react with elafibranor, preventing its full absorption.

Do not increase your dose or take this medication more often or for longer than prescribed. Your condition will not improve any faster, and your risk of side effects will increase.

Take this medication regularly to get the most benefit from it. To help you remember, take it at the same time each day.

Tell your doctor if your condition gets worse.

Diarrhea, nausea, vomiting, constipation, heartburn, dry mouth, joint pain, or weight changes may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including:

• bone pain

This drug may rarely cause muscle problems (which can rarely lead to a very serious condition called rhabdomyolysis). Tell your doctor right away if you develop any of these symptoms:

• muscle pain/tenderness/weakness (especially with fever or unusual tiredness)
• signs of kidney problems (such as change in the amount of urine)

This medication may rarely cause gallbladder and other liver problems. Tell your doctor right away if you notice any of these serious side effects:

• nausea/vomiting that doesn't stop
• loss of appetite
• stomach/abdominal pain
• yellowing eyes/skin
• dark urine

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including:

• rash
• itching/swelling (especially of the face/tongue/throat)
• severe dizziness
• trouble breathing

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US - Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Before taking elafibranor, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of:

• other liver problems (such as ascites, encephalopathy)
• muscle pain
• osteoporosis

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Tell your doctor if you are pregnant or plan to become pregnant. You should not become pregnant while using elafibranor. Elafibranor may harm an unborn baby. Your doctor should order a pregnancy test before you start this medication. Ask about the use of reliable forms of non-hormonal birth control (such as condoms, diaphragm with spermicide) during treatment and for 3 weeks after the last dose. If you become pregnant, talk to your doctor right away about the risks and benefits of this medication.

It is unknown if this medication passes into breast milk. Because of the possible risk to the infant, breastfeeding is not recommended while using this medication and for 3 weeks after the last dose. Consult your doctor before breastfeeding.

See also How to Use section.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

This medication may decrease the effectiveness of hormonal birth control such as pills, patch, or ring. This could cause pregnancy. Discuss with your doctor or pharmacist if you should use reliable backup birth control methods while using this medication and for at least 3 weeks after the last dose. Also tell your doctor if you have any new spotting or breakthrough bleeding, because these may be signs that your birth control is not working well.

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call 1-800-222-1222. Canada residents can call 1-844-764-7669.

Do not share this medication with others.

Lab and/or medical tests (such as liver function, CPK levels) should be done before you start taking this medication and while you are taking it. Keep all medical and lab appointments. Consult your doctor for more details.

If you miss a dose, ask your doctor or pharmacist right away for a new dosing schedule. Do not double the dose to catch up.

Different brands of this medication have different storage needs. Check the product package for instructions on how to store your brand, or ask your pharmacist. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.