Iqirvo is a brand-name oral tablet prescribed for a certain type of autoimmune liver disease. Iqirvo contains the active ingredient elafibranor and belongs to the peroxisome proliferator-activated receptor (PPAR) agonist drug class.

Specifically, the Food and Drug Administration (FDA) has granted accelerated approval to Iqirvo to treat primary biliary cholangitis (PBC).

Drug details

You’ll find key information about Iqirvo here:

  • Drug class: peroxisome proliferator-activated receptor (PPAR) agonists
  • Drug form: oral tablet
  • Generic available? no
  • Prescription required? yes
  • Controlled substance? no
  • Accelerated approval? yes

Iqirvo is available only as a brand-name medication. It’s not currently available in generic form.

A generic drug is an exact copy of the active ingredient in a brand-name medication. Generics usually cost less than brand-name drugs.

The Iqirvo dosage your doctor prescribes will depend on several factors. These include other medical conditions you may have and other medications you may take.

The following information describes dosages that are commonly used or recommended. However, be sure to take the dosage your doctor prescribes for you. Your doctor will determine the best dosage to fit your needs.

Drug forms and strengths

Iqirvo comes as a tablet that you take by mouth. It’s available in one strength: 80 milligrams (mg).

Dosage for primary biliary cholangitis (PBC)

The recommended dosage for Iqirvo in adults with PBC is 80 mg once per day.

About taking Iqirvo

You’ll find information about key dosage issues here:

  • When to take: You should take Iqirvo once per day around the same time each day.Taking the medication around the same time of day helps keep a steady level of the drug in your body. This helps Iqirvo work effectively.
  • If you miss a dose: If you miss a dose, skip the missed dose. Take your next dose at your regular time. Do not take a double dose to make up for the missed dose.
  • Taking Iqirvo with food: Iqirvo can be taken with or without food.
  • Crushing, splitting, or chewing Iqirvo: The manufacturer of Iqirvo does not address whether Iqirvo tablets can be crushed, split, or chewed. Swallow the tablets whole. If you have difficulty swallowing tablets, talk with your doctor.
  • Length of use: Iqirvo is meant to be a long-term treatment. If you and your doctor determine that Iqirvo is safe and effective for you, you’ll likely take it long term.
  • Length of time to work: In clinical trials, Iqirvo started to work within four weeks. However, the time it takes Iqirvo to work can vary.

Iqirvo can cause mild or serious side effects. The following lists contain some of the key side effects that may occur while taking Iqirvo. These lists do not include all possible side effects.

For more information about the possible side effects of Iqirvo, talk with your doctor or pharmacist. They can give you tips on how to manage any side effects that may be concerning or bothersome.

Note: After the Food and Drug Administration (FDA) approves a drug, it tracks and reviews side effects of the medication. Sharing your experience helps make medications safer for everyone by giving doctors and researchers more information about how the drug works in real life. If you develop a side effect while taking Iqirvo and want to tell the FDA about it, visit MedWatch or call 800-FDA-1088.

Mild side effects

Here is a partial list of mild side effects of Iqirvo. To learn about other mild side effects, talk with your doctor or pharmacist, or view Iqirvo’s prescribing information.

Mild side effects of Iqirvo can include:

  • weight changes
  • diarrhea
  • abdominal pain
  • nausea
  • vomiting
  • joint pain
  • constipation
  • mild muscle pain
  • acid reflux
  • dry mouth
  • rash

Most of these side effects may go away within a few days to a couple of weeks. However, if they become more severe or don’t go away, talk with your doctor or pharmacist.

Serious side effects

Serious side effects from Iqirvo aren’t common, but they can occur. Call your doctor right away if you have serious side effects. Call 911 or your local emergency phone number if your symptoms feel life threatening or you think you’re having a medical emergency.

Serious side effects can include:

  • severe muscle problems
  • bone fractures (a crack or break in your bone)
  • liver problems
  • gallstones
ALLERGIC REACTION

For some people, Iqirvo can cause an allergic reaction.

This side effect occurred in the drug’s studies.

In general, symptoms of an allergic reaction can be mild or serious.

Ways to manage

For mild allergic reaction symptoms, such as a mild rash, call your doctor right away. They may recommend treatments to help manage your symptoms. They’ll also let you know whether you should keep taking the medication.

For severe allergic reaction symptoms, such as swelling or trouble breathing, call 911 or your local emergency number right away. These symptoms require immediate medical care because they can become life threatening. If you’ve had a serious allergic reaction to Iqirvo, your doctor may recommend a different medication instead.

Iqirvo was granted accelerated approval from the FDA to treat primary biliary cholangitis in adults.

Iqirvo for primary biliary cholangitis (PBC)

Doctors prescribe Iqirvo to treat PBC, a condition characterized by inflammation and damage to bile ducts in the liver. This causes bile and toxins to build up in the liver, which can result in permanent scarring and liver cirrhosis. Symptoms of PBC may include itchiness, joint pain, extreme fatigue, jaundice, and darkening of your skin tone.

Iqirvo contains the active drug elafibranor. It isn’t fully clear how elafibranor works to treat PBC, but it is thought to encourage bile acid transportation, slow bile production, and decrease inflammation.

For this purpose, Iqirvo may be prescribed on its own or with ursodeoxycholic acid (a bile acid) for PBC.

Iqirvo and children

The FDA has not granted accelerated approval for the use of Iqirvo in children. If your child is experiencing symptoms of PBC, talk with your child’s doctor.

Iqirvo can interact with several other medications. It can also interact with certain supplements and foods.

Before taking Iqirvo, talk with your doctor and pharmacist. Tell them about all prescription, over-the-counter, and other drugs you take. Also tell them about any vitamins, herbs, and supplements you use. Sharing this information can help you avoid potential interactions.

Interactions with medications, foods, and supplements

Here is a list of medications, supplements, and foods that can interact with Iqirvo. This list does not contain all drugs that may interact with Iqirvo. If you have questions about drug interactions that may affect you, ask your doctor or pharmacist.

Medications that can interact with Iqirvo• statin medications, such as Lipitor (atorvastatin) and Crestor (rosuvastatin)
• hormonal contraceptives, such as combination birth control pills, birth control patches, and Nexplanon
• rifampin (Rifadin)
• bile acid sequestrants, such as cholestyramine (Questran) and colesevelam (Welchol)

Alcohol interaction

Alcohol is not known to interact with Iqirvo. However, Iqirvo and heavy alcohol consumption can both cause liver problems. Therefore, mixing these substances can increase the likelihood of this side effect occurring. If you have questions about how much alcohol is safe to drink while taking Iqirvo, talk with your doctor or pharmacist.

As with all medications, the cost of Iqirvo can vary. The actual price you’ll pay depends on your insurance plan, your location, and the pharmacy you use.

Financial and insurance assistance: If you need financial support to pay for Iqirvo or help understanding your insurance coverage, help is available. A program called IPSEN CARES is available for Iqirvo. For more information and to find out if you’re eligible for support, call 866-435-5677 or visit the program website.

Generic version: Iqirvo is not available in a generic form. A generic drug is an exact copy of the active ingredient in a brand-name medication. Generics tend to cost less than brand-name drugs.

Other drugs are available that can treat your condition. Some may be a better fit for you than others. If you’re interested in finding an alternative to Iqirvo, talk with your doctor. They can tell you about other medications that may work well for you.

The following drugs are alternatives to Iqirvo:

  • ursodiol (Actigall)
  • seladelpar (Livdelzi)
  • obeticholic acid (Ocaliva)

If you can become pregnant, consider the following information about pregnancy, birth control, and breastfeeding.

Iqirvo and pregnancy

Iqirvo should not be taken during pregnancy. If you’re planning a pregnancy or can become pregnant, talk with your doctor before taking this medication. Your doctor may suggest birth control options to use during treatment with Iqirvo and for at least three weeks after your last dose of the medication.

Iqirvo and birth control

It is not safe to take Iqirvo during pregnancy. If you’re sexually active and you or your partner can become pregnant, talk with your doctor about your birth control options while you’re taking Iqirvo. They’ll likely recommend that you use an effective birth control method during treatment and for three weeks after your last dose of Iqirvo.

Note: The use of binary terms such as “male” and “female” or “men” and “women” in this article reflects the language of the sources we’ve used. Unless otherwise noted, it’s unclear whether the research we reference included participants with expansive gender identities.

For females using Iqirvo

Before starting Iqirvo, your doctor will likely order a pregnancy test to make sure you aren’t pregnant. If you and your partner can become pregnant, your doctor will likely recommend that you use an effective birth control method during Iqirvo treatment and for three weeks after your last dose.

Iqirvo and breastfeeding

Iqirvo should not be taken while breastfeeding. If you’re currently breastfeeding or planning to do so, talk with your doctor before taking this medication. Your doctor may suggest a different treatment for your condition or recommend other ways to feed a child who is breastfed.

Here are answers to some frequently asked questions about Iqirvo.

Is Iqirvo available at any pharmacy?

No, Iqirvo is only available through certain specialty pharmacies that have a partnership with the manufacturer. If you and your doctor decide it’s safe for you to start Iqirvo treatment, your doctor will send your prescription to an Iqirvo specialty pharmacy. The pharmacy will call you to confirm your prescription and discuss the cost of your treatment.

If you have more questions about where you can get Iqirvo, talk with your doctor.

How does Iqirvo work?

Iqirvo belongs to the peroxisome proliferator-activated receptor (PPAR) agonist drug class. By targeting PPAR proteins in the liver, Iqirvo helps reduce liver inflammation and decrease the levels of bile acids. This helps improve the symptoms of primary biliary cholangitis and protects your liver from further damage.

If you have more questions about how Iqirvo works, talk with your doctor.

Before taking Iqirvo, discuss your health history with your doctor. Iqirvo may not be right for you if you have certain medical conditions or other factors affecting your health. Be sure to talk with your doctor if any of the following apply to you:

  • liver problems, such as advanced liver disease
  • blockage in your bile ducts, such as gallstones
  • previous allergic reaction to this or a similar drug
  • pregnancy
  • breastfeeding

Note: For more information about the potential negative effects of Iqirvo, see the “Iqirvo side effects” section.

Disclaimer: Medical News Today has made every effort to make certain that all information is factually correct, comprehensive, and up to date. However, this article should not be used as a substitute for the knowledge and expertise of a licensed healthcare professional. You should always consult your doctor or another healthcare professional before taking any medication. The drug information contained herein is subject to change and is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. The absence of warnings or other information for a given drug does not indicate that the drug or drug combination is safe, effective, or appropriate for all patients or all specific uses.