Elafibranor

Generic name: elafibranor [ EL-a-FIB-ra-nor ]
Brand name: Iqirvo
Dosage form: oral tablet (80 mg)
Drug class: Miscellaneous metabolic agents

Medically reviewed by Drugs.com on Jul 29, 2024. Written by Cerner Multum.

What is elafibranor?

Elafibranor is used in adults to treat a chronic liver disease called primary biliary cholangitis.

Elafibranor is sometimes used with another medicine called ursodeoxycholic acid.

Elafibranor may also be used for purposes not listed in this medication guide.

Elafibranor side effects

Get emergency medical help if you have signs of an allergic reaction: hives, difficult breathing, swelling of your face, lips, tongue, or throat.

Elafibranor can cause the breakdown of muscle tissue, which can lead to kidney failure. Call your doctor right away if you have unexplained muscle pain, tenderness, or weakness especially if you also have fever, unusual tiredness, or dark urine.

Elafibranor may cause serious side effects. Call your doctor at once if you have:

• stomach pain, nausea, vomiting, diarrhea, weight loss, loss of appetite;

• new or worsening tiredness, weakness;

• fever, chills;

• feeling light-headed;

• urination problems;

• sudden pain or trouble moving your hip, wrist, or back; or

• liver problems--swelling around your midsection, right-sided upper stomach pain, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Your treatment with elafibranor may be delayed or permanently discontinued if you have certain side effects.

Common side effects of elafibranor may include:

• diarrhea, constipation, nausea, vomiting, stomach pain, dry mouth;

• heartburn, chest pain, trouble swallowing;

• joint pain, broken bones, muscle problems;

• weight changes; or

• rash.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Related/similar drugs

Ocaliva, ursodiol, Actigall, Iqirvo, seladelpar

Warnings

Elafibranor can cause the breakdown of muscle tissue, which can lead to kidney failure. Call your doctor right away if you have unexplained muscle pain, tenderness, or weakness especially if you also have fever, unusual tiredness, or dark urine.

Also call your doctor if you have swelling around your midsection, right-sided upper stomach pain, loss of appetite, dark urine, clay-colored stools, or jaundice (yellowing of the skin or eyes).

Before taking this medicine

Tell your doctor if you have or have ever had:

• severe liver disease.

May harm an unborn baby. Use effective birth control while using elafibranor and for at least 3 weeks after your last dose. Tell your doctor if you become pregnant.

If you are pregnant, your name may be listed on a pregnancy registry to track the effects of elafibranor on the baby.

Do not breastfeed while using elafibranor, and for at least 3 weeks after your last dose.

How should I take elafibranor?

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

You may take elafibranor with or without food.

Your blood may need to be tested often.

Store this medicine in the original container at room temperature away from moisture and light.

Elafibranor dosing information

Usual Adult Dose for Primary Biliary Cholangitis:

80 mg orally once a day

Comments:
-Administer with or without food.
-Prior to treatment, evaluate patients for muscle pain or myopathy, and verify that females of reproductive potential are not pregnant.
-Limitations of use: This drug not recommended for use in patients who have or develop decompensated cirrhosis (e.g., ascites, variceal bleeding, hepatic encephalopathy).

Uses:
-As monotherapy, for the treatment of primary biliary cholangitis (PBC) in patients unable to tolerate ursodeoxycholic acid (UDCA)
-In combination with UDCA, for the treatment of PBC in patients who have had an inadequate response to UDCA

What happens if I miss a dose?

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What should I avoid while taking elafibranor?

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

What other drugs will affect elafibranor?

Avoid taking a bile acid binding resin such as cholestyramine, colestipol, or colesevelam within 4 hours before or after you take elafibranor.

Tell your doctor about all your other medicines, especially:

• rifampin.

This list is not complete. Other drugs may affect elafibranor, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.

Further information

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Medical Disclaimer

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