Elafibranor (el-a-FIB-ra-nor)

Treats primary biliary cholangitis (swelling of the bile duct).

Brand Name(s):

Iqirvo

When This Medicine Should Not Be Used:

How to Use This Medicine:

Tablet

• Your doctor will tell you how much medicine to use. Do not use more than directed.
• This medicine should come with a Medication Guide. Ask your pharmacist for a copy if you do not have one.
• Missed dose: Take a dose as soon as you remember. If it is almost time for your next dose, wait until then and take a regular dose. Do not take extra medicine to make up for a missed dose.
• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Some medicines can affect how elafibranor works. Tell your doctor if you are using rifampin, birth control pills, or medicine to lower cholesterol.
• Take this medicine at least 4 hours before or 4 hours after using bile acid sequestrants (eg, cholestyramine, colesevelam, colestipol).

Warnings While Using This Medicine:

• It is not safe to take this medicine during pregnancy. It could harm an unborn baby. Tell your doctor right away if you become pregnant. If you can get pregnant, your doctor may do tests to make sure you are not pregnant before starting this medicine. Use an effective form of birth control to keep from getting pregnant during treatment and for at least 3 weeks after your last dose.
• Do not breastfeed during treatment with this medicine and for 3 weeks after the last dose.
• Tell your doctor if you have kidney disease or liver disease.
• This medicine may cause the following problems:
  • Serious muscle problems, including myalgia, myopathy, rhabdomyolysis
  • Bone fractures
  • Liver problems
  • Gallstones, which may lead to bile duct blockage
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Bone pain or fractures
• Dark urine or pale stools, nausea, vomiting, loss of appetite, stomach pain or discomfort, yellow skin or eyes
• Difficulty in moving, joint pain, muscle pain, tenderness, or weakness

If you notice these less serious side effects, talk with your doctor:

• Constipation, diarrhea, stomach upset
• Dry mouth
• Weight gain or loss

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088