Iqirvo: Uses, Side Effects & Warnings

Generic name: Elafibranor

Pregnancy & Lactation: Risk data not available

What is Iqirvo?

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.

Warnings

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 this medicine, and for at least 3 weeks after your last dose.

How should I use Iqirvo

Use Iqirvo (Oral) exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended.

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.

What should I do if I missed a dose of Iqirvo (Oral)?

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.

Iqirvo 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.

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 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.

What other drugs will affect Iqirvo?

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

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