Elafibranor

Elafibranor is used alone or in combination with ursodiol to treat primary biliary cholangitis (PBC; a type of liver disease that destroys bile ducts, which allows bile to stay in the liver and cause damage) in people who cannot take ursodiol or in people who were not treated successfully with ursodiol alone. Elafibranor is in a class of medications called peroxisome proliferator-activated receptor (PPAR) agonists. It works by decreasing the production of bile acids and increasing movement of bile acids out of the liver, resulting in decreased toxic levels of bile acids that accumulate in the liver.

Elafibranor comes as a tablet to take by mouth. It is usually taken once a day with or without food. Take elafibranor at around the same time every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take elafibranor exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Your doctor or pharmacist will give you the manufacturer's patient information sheet (Medication Guide) when you begin treatment with elafibranor. You can also visit the Food and Drug Administration (FDA) website (https://www.fda.gov/Drugs/DrugSafety/ucm085729.htm) or the manufacturer's website to obtain the Medication Guide.

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

Before taking elafibranor,

• tell your doctor and pharmacist if you are allergic to elafibranor, any other medications, or any of the ingredients in elafibranor tablets. Ask your pharmacist or check the Medication Guide for a list of the ingredients.
• tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
• if you are taking a bile acid resin such as cholestyramine, colesevelam, or colestipol, take it at least 4 hours after or 4 hours before you take elafibranor.
• tell your doctor if you have cirrhosis of the liver. Your doctor may tell you not to take elafibranor.
• tell your doctor if you have or have ever had osteoporosis (a condition in which the bones become thin and weak and break easily), muscle aches or weakness, or liver disease.
• tell your doctor if you are pregnant or plan to become pregnant. You will need to have a pregnancy test before you start treatment with elafibranor. Elafibranor may interfere with the action of hormonal contraceptives (birth control pills, patches, rings, implants, or injections), so you should not use these as your only method of birth control during your treatment. You must use a non-hormonal birth control such as a barrier method (device that blocks sperm from entering the uterus such as a condom or a diaphragm) during your treatment and for 3 weeks after your final dose. Talk to your doctor about birth control methods that you can use. If you become pregnant, call your doctor immediately. Elafibranor may harm the fetus.
• tell your doctor if you are breastfeeding or plan to breastfeed. You should not breastfeed while you are taking elafibranor and for 3 weeks after the final dose.

Unless your doctor tells you otherwise, continue your normal diet.

Take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

Elafibranor may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• diarrhea
• stomach pain
• nausea
• vomiting
• constipation
• heartburn
• weight loss or gain
• dry mouth
• joint pain
• fever and chills
• weakness
• lightheadedness

Some side effects can be serious. If you experience any of these symptoms,,call your doctor immediately or get emergency medical treatment:

• yellowing of the skin or eyes
• pain in the upper right part of the stomach
• new or worsening fatigue; loss of appetite; or swelling of legs of feet
• swelling in and around the stomach area; black, tarry, or bloody stools; coughing up or vomiting blood; confusion, slurred speech, anxiety, mood swings, or changes in personality
• rash; itching; swelling of the face, eyes, mouth, throat, tongue, or lips; or difficulty breathing or swallowing
• dark-colored urine; unexplained muscle pain, tenderness, or weakness; or tiredness
• fracture of the bone or severe bone pain

Taking elafibranor may increase the risk that you will experience a bone fracture. Talk to your doctor about the risk of taking this medication and about ways to keep your bones healthy during your treatment.

Elafibranor may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (https://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from light, excess heat and moisture (not in the bathroom).

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. https://www.upandaway.org

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (https://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

Keep all appointments with your doctor and the laboratory. Your doctor will order certain lab tests before starting therapy and regularly during therapy to check your body's response to elafibranor. Your doctor will also check you for muscle weakness or pain before starting therapy and regularly during therapy.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

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