Why is this medicine prescribed?
Elafibranor is used to treat primary biliary cholangitis (PBC; a type of liver disease that destroys bile ducts, causing bile to build up and damage the liver). Elafibranor is in a class of medications called peroxisome proliferator-activated receptor (PPAR) agonists. It works by decreasing bile acid production and helps move bile acids out of the liver, reducing harmful bile acid buildup.
Are there other uses for this medicine?
This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.
How should this medicine be used?
Elafibranor comes as a tablet to take by mouth. Take once a day with or without food. Take at around the same time every day.
Take elafibranor exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.
What special precautions should I follow?
Before taking elafibranor,
- tell your doctor or pharmacist if you are allergic to this medication, any part of this medication, or any other medications, foods or substances. Tell your doctor or pharmacist about the allergy and what symptoms you had.
- you should know that some medications should not be taken with elafibranor. Other medications may cause dosing changes or extra monitoring when taken with elafibranor. Make sure you have discussed any medications you are currently taking or plan to take before starting elafibranor with your doctor and pharmacist. Before starting, stopping, or changing any medications while taking elafibranor, please get the advice of your doctor or pharmacist.
- you should know that 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 elafibranor.
- you should know that elafibranor may decrease the effectiveness of hormonal contraceptives (birth control pills, patches, rings, and injections). You will need to use another method of contraception to prevent pregnancy while taking elafibranor. Talk to your doctor about other ways to prevent pregnancy while you are taking this medication.
- 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 may need to have a pregnancy test before you start treatment with elafibranor. You should use an effective method of birth control while you are taking elafibranor and for 3 weeks after the last dose of elafibranor. 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.
What special dietary instructions should I follow?
Unless your doctor tells you otherwise, continue your normal diet.
What should I do if I forget to take a dose?
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.
What should I do in case of overdose?
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.
What side effects can this medicine cause?
Elafibranor may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:
- nausea, vomiting, diarrhea; stomach pain
- 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; new or worsening fatigue; loss of appetite; or swelling of legs of feet; pain in the upper right part of the stomach; dark-colored urine; unexplained muscle pain, tenderness, or weakness; or tiredness
- 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
- 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).What should I know about storage and disposal of this medication?
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).
Keep all medication out of sight and reach of children as many containers are not child-resistant. Always lock safety caps. Place the medication in a safe location – one that is up and away and out of their sight and reach. https://www.upandaway.org Dispose of unneeded medications in a way so that pets, children, and other people cannot take them. Do not flush this medication down the toilet. Use a medicine take-back program. Talk to your pharmacist about take-back programs in your community. Visit the FDA's Safe Disposal of Medicines website https://goo.gl/c4Rm4p for more information.What other information should I know?
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.
Keep a written list of all of the prescription and nonprescription (over-the-counter) medicines, vitamins, minerals, and dietary supplements you are taking. Bring this list with you each time you visit a doctor or if you are admitted to the hospital. You should carry the list with you in case of emergencies.