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PPAR AGONIST
Iqirvo (elafibranor) is a prescription medication approved by the U.S. Food and Drug Administration (FDA) to treat adults with primary biliary cholangitis (PBC).
These insights are based on 162 comments about Iqirvo from myPBCteam members. These are the experiences of a small number of people and are not meant to be medical advice.
Benefits:
Considerations:
Iqirvo is a type of medicine called a peroxisome proliferator-activated receptor agonist (PPAR). It activates proteins that may help reduce the production of bile acids in the liver. The exact way Iqirvo works in people with primary biliary cholangitis is not fully understood.
Doctors prescribe Iqirvo with ursodeoxycholic acid for adults with PBC who have not responded well enough to ursodeoxycholic acid. Iqirvo may also be used alone in adults who cannot tolerate ursodeoxycholic acid.
Iqirvo is a tablet taken by mouth once daily. It can be taken with or without food.
The recommended dose of Iqirvo is 80 milligrams by mouth once daily.
People who also take a bile acid sequestrant should take Iqirvo at least four hours before or four hours after that medicine. If this is not possible, the medicines should be taken as far apart as possible.
This information is based on prescribing information, but your healthcare provider may tailor your treatment plan. Always follow their guidance.
These insights are based on 162 comments about Iqirvo from myPBCteam members.
Members who use Iqirvo often say it helps to stay in close contact with their care team, especially about lab results, side effects, and insurance issues. Many also describe building simple routines around taking the medication, tracking how they feel, and giving side effects time to settle when their doctor agrees it is safe to continue.
Get blood work when your doctor orders it.
“My doctor put me on Iqirvo one month ago. I’m supposed to get labs drawn this week to see how things are going.”
Tell your doctor about side effects and patterns.
“After taking 30 pills, I developed an allergic reaction, my face beginning to get numb and tingling and around my mouth. Took a couple of Benadryl and it subsided. Doctor took me off.”
Build a routine for taking Iqirvo.
“I take it first thing in the morning, with food and a full glass of water. It helps me with my stomach pain.”
Connect with others who understand life with primary biliary cholangitis. Join myPBCteam for free.
In clinical studies of Iqirvo the most common side effects occurred in about 5 percent to 23 percent of people. These include:
Iqirvo can cause serious side effects that may require immediate medical attention. These include:
Get medical help right away if you think you are having a serious reaction.
Ipsen Biopharmaceuticals, Inc, the manufacturer of Iqirvo, offers the Iqirvo Copay Assistance Program. Eligible people with commercial insurance may pay as little as $0 per prescription.
The IPSEN CARES patient support program also offers help understanding insurance coverage, accessing financial assistance, and receiving personalized support and education throughout treatment.
To learn more, visit the IPSEN CARES patient support program website or call 866 435-5677.
Before starting Iqirvo, your doctor will:
Tell your doctor if you have any allergies to elafibranor or any ingredients in Iqirvo.
Tell your doctor about all medicines you take, including prescription drugs, over-the-counter medicines, vitamins, and herbal supplements.
Tell your doctor if you:
Iqirvo may harm your baby if you are pregnant. You should not become pregnant during treatment.
If you can become pregnant, use effective nonhormonal birth control during treatment and for three weeks after your last dose. If you use hormonal birth control, add a barrier method, such as a condom.
Do not breastfeed during treatment with Iqirvo or for three weeks after your last dose.
Tell your doctor right away if you become pregnant while taking Iqirvo. You or your doctor can report the pregnancy to the Iqirvo pregnancy safety study by visiting the Ipsen website or calling 855-463-5217.
These answers are fact-checked by our editorial staff.
How effective is Iqirvo for PBC?
Iqirvo was studied in adults with PBC. After 52 weeks, 51 percent of people taking Iqirvo had a biochemical response. This means their liver blood test results met certain goals. In comparison, 4 percent of people taking placebo had a biochemical response.
Iqirvo also lowered alkaline phosphatase (ALP) more than placebo. ALP is a liver blood test. A greater drop in ALP was seen as early as four weeks and was generally maintained through week 52.
It is not known whether Iqirvo improves survival or prevents liver decompensation.
How long does Iqirvo take to work for PBC?
In the main study, a greater reduction in ALP was seen as early as four weeks after starting Iqirvo. Lower ALP levels were generally maintained through week 52.
What tests or monitoring are needed with Iqirvo for PBC?
Before starting Iqirvo, your doctor should:
During treatment, your doctor should monitor your liver tests as part of routine care. Important tests may include ALT, AST, total bilirubin, and alkaline phosphatase.
Your doctor may also check for signs of muscle injury and may order a blood test called creatine phosphokinase (CPK).
If your liver test results get worse, or you develop signs of liver injury, your doctor may stop Iqirvo for a time and perform more testing.
On myPBCteam, people share their experiences with primary biliary cholangitis, get advice, and find support from others who understand.
Learn more about Iqirvo and primary biliary cholangitis care:
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