Description and Brand Names

Drug information provided by: Merative, Micromedex®

US Brand Name

  1. Iqirvo

Descriptions


Elafibranor is used in combination with ursodeoxycholic acid (UDCA) to treat primary biliary cholangitis (PBC) in patients who have received UDCA but did not work well or used alone in patients who are unable to tolerate UDCA.

This medicine is available only with your doctor's prescription.

This product is available in the following dosage forms:

  • Tablet

Before Using

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of elafibranor in the pediatric population. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of elafibranor in the elderly.

Breastfeeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Drug Interactions

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Atorvastatin
  • Cholestyramine
  • Colesevelam
  • Colestipol
  • Desogestrel
  • Dienogest
  • Drospirenone
  • Estetrol
  • Estradiol
  • Ethinyl Estradiol
  • Ethynodiol
  • Etonogestrel
  • Fluvastatin
  • Gestodene
  • Levonorgestrel
  • Lovastatin
  • Medroxyprogesterone
  • Mestranol
  • Nomegestrol
  • Norelgestromin
  • Norethindrone
  • Norgestimate
  • Norgestrel
  • Pitavastatin
  • Pravastatin
  • Rifampin
  • Rosuvastatin
  • Segesterone
  • Simvastatin
  • Ulipristal

Other Interactions

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

  • Liver disease (eg, decompensated cirrhosis, ascites, variceal bleeding, hepatic encephalopathy)—Use is not recommended in patients with this condition.

Proper Use

Take this medicine exactly as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. To do so may increase the chance of side effects.

This medicine should come with a Medication Guide. Read and follow these instructions carefully. Ask your doctor if you have any questions.

You may take this medicine with or without food.

Take this medicine at least 4 hours before or 4 hours after using bile acid sequestrants (eg, cholestyramine, colesevelam, colestipol).

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

  • For oral dosage form (tablets):
    • For treatment of primary biliary cholangitis:
      • Adults—80 milligrams (mg) once a day.
      • Children—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions

It is very important that your doctor check your progress at regular visits to see if the medicine is working properly and to decide if you should continue to take it. Blood tests may be needed to check for any unwanted effects.

Using this medicine while you are pregnant can harm your unborn baby. 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. If you think you have become pregnant while using the medicine, tell your doctor right away.

This medicine may cause serious muscle problems (eg, myalgia, myopathy, rhabdomyolysis). Check with your doctor right away if you have dark urine, difficulty moving, fever, joint pain, muscle cramps, spasms, pains, stiffness, tenderness, or wasting, or unusual tiredness or weakness.

This medicine may cause bone fractures. Call your doctor right away if you develop pain or have changes in your ability to move around.

Check with your doctor right away if you have confusion, coughing up blood, dark urine, clay-colored stools, mood swings, slurred speech, stomach pain, vomiting of blood or material that looks like coffee grounds, or yellow eyes or skin. These may be symptoms of a serious liver problem.

This medicine may cause serious allergic reactions, which can be life-threatening and require immediate medical attention. Check with your doctor right away if you have difficulty breathing or swallowing, fast heartbeat, skin itching, rash, or redness, or swelling of the face, throat, or tongue.

This medicine may increase your risk of having gallstones, which may lead to bile duct blockage. Check with your doctor right away if you have severe stomach pain with nausea and vomiting, upper stomach pain, or yellow skin.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

  1. Muscle pain
  2. pain or swelling in the arms or legs without any injury

Less common

  1. Agitation
  2. coma
  3. confusion
  4. dark urine
  5. decreased urine output
  6. depression
  7. dizziness
  8. difficulty in moving
  9. fever
  10. gaseous stomach pain
  11. headache
  12. hostility
  13. indigestion
  14. irritability
  15. joint pain
  16. lethargy
  17. muscle aches, cramps, stiffness, or twitch
  18. nausea
  19. pale skin
  20. seizures
  21. stomach fullness
  22. stupor
  23. swelling of the face, ankles, or hands
  24. swollen joint
  25. trouble breathing
  26. unusual bleeding or bruising
  27. unusual tiredness or weakness
  28. vomiting
  29. yellow eyes or skin

Incidence not known

  1. Difficulty swallowing
  2. fast heartbeat
  3. loss of appetite
  4. skin itching, rash, or redness
  5. swelling of the face, throat, or tongue

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

  1. Constipation
  2. diarrhea
  3. dry mouth
  4. heartburn
  5. weight gain or loss

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

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

Portions of this document last updated: Aug. 01, 2024

Original article: https://www.mayoclinic.org/ar/drugs-supplements/elafibranor-oral-route/precautions/drg-20571306