Iqirvo
Iqirvo (elafibranor) has an accelerated approval from the FDA for treating primary biliary cholangitis (PBC) in adults. It works as a peroxisome proliferator-activated receptor (PPAR) agonist to help the body make less bile acid. But it’s not clear yet if the medication helps people with PBC live longer or helps the liver improve. Iqirvo (elafibranor) comes as an 80 mg tablet that's taken by mouth once per day. You can take Iqirvo (elafibranor) by itself or with ursodiol (Actigall). Side effects of Iqirvo (elafibranor) include weight gain, diarrhea, and stomach pain.
What is Iqirvo (elafibranor)?
What is Iqirvo (elafibranor) used for?
- Primary biliary cholangitis (PBC), a liver problem caused by damaged bile ducts
How Iqirvo (elafibranor) works
Iqirvo (elafibranor) is a peroxisome proliferator-activated receptor (PPAR) agonist. It attaches to certain PPAR receptors in the liver.
It's not completely clear how Iqirvo (elafibranor) works to help with primary biliary cholangitis (PBC). But it's thought to stop the liver from making bile acids, a component of bile. This is important because people with PBC have too much bile in the liver, which can hurt the liver.
Drug facts
Side effects of Iqirvo (elafibranor)
The following side effects may get better over time as your body gets used to the medication. Let your healthcare provider know immediately if you continue to experience these symptoms or if they worsen over time.
Common Side Effects
- Weight gain (23%)
- Diarrhea (11%)
- Stomach pain (11%)
- Nausea (11%)
- Vomiting (11%)
- Joint pain (8%)
- Constipation (8%)
- Muscle pain (7%)
- Broken bone (fracture, 6%)
- Heartburn (6%)
- Dry mouth (5%)
- Weight loss (5%)
- Rash (5%)
Less Common Side Effects
- Dizziness
- Stomach flu
- Gallstones
- Higher creatinine levels
- Low red blood cell count (anemia)
Iqirvo (elafibranor) serious side effects
Contact your healthcare provider immediately if you experience any of the following.
- Severe muscle damage (rhabdomyolysis): dark brown urine, severe muscle weakness or pain, fever, tiredness
- Worsening liver problems: swelling of your stomach; yellowing of your skin or the whites of your eyes; stool changes (black, tarry, or bloody stools); coughing or vomiting up blood; confusion; slurred speech; changes in personality
- Bone fracture: bone looks misshapen, swelling, bruising, pain
- Allergic reactions: rash; itching; trouble breathing; swelling of your face, lips, tongue, or throat
The following Iqirvo (elafibranor) side effects have also been reported
Side effects that you should report to your care team as soon as possible:
- Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat
- Liver injury—right upper belly pain, loss of appetite, nausea, light-colored stool, dark yellow or brown urine, yellowing skin or eyes, unusual weakness or fatigue
- Muscle injury—unusual weakness or fatigue, muscle pain, dark yellow or brown urine, decrease in amount of urine
Side effects that usually do not require medical attention (report these to your care team if they continue or are bothersome):
- Diarrhea
- Joint pain
- Nausea
- Stomach pain
- Vomiting
- Weight gain
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Pros and cons of Iqirvo (elafibranor)
Pros
- Taken by mouth once per day
- A good option if treatment with ursodiol (Actigall) isn't enough or if you can't take ursodiol (Actigall)
- Helps improve levels of alkaline phosphatase (ALP), a liver enzyme that can be high with liver damage
Cons
- Might cause muscle pain
- Can raise the risk of bone fractures
- Not known for sure if the medication helps people with PBC live longer or slow down liver damage
Pharmacist tips for Iqirvo (elafibranor)
- Mark your calendar with your appointments to see your prescriber. Also make sure to get blood work done to check your liver function. These follow-ups are important to see how well Iqirvo (elafibranor) is well and check for side effects.
- Take Iqirvo (elafibranor) with or without food at any time of day. But taking it with food might help with any stomach pain, nausea, vomiting, and acid reflux from the medication. These are common side effects of Iqirvo (elafibranor).
- Iqirvo (elafibranor) can raise the risk of fractures (broken bone). Get medical care if you think you've broken a bone and have swelling, bruising, and pain when you move the bone. Tell your prescriber if you have any bone problems, like osteoporosis.
- Tell your prescriber and pharmacist about all the medications you take. Don't start any new ones without talking to your care team first. Iqirvo (elafibranor) can interact with other medications, so your care team should make sure they're all safe to take together. Some examples of medications that interact with Iqirvo (elafibranor) include statins, rifampin (Rifadin), and hormonal birth control.
- If you take bile acid sequestrants like colesevelam (Welchol), colestipol (Colestid), or cholestyramine (Prevalite), take them at least 4 hours before or 4 hours after Iqirvo (elafibranor). If that's not possible, try to take the bile acid sequestrant and Iqirvo (elafibranor) as far apart as you can. Taking them too close together can make Iqirvo (elafibranor) work less well.
- If you're sexually active and can get pregnant, use nonhormonal birth control, like Paragard (copper intrauterine device) or condoms, while taking Iqirvo (elafibranor). If you use hormonal birth control, use a barrier method, like condoms, too. Iqirvo (elafibranor) can make hormonal birth control work less well and raise the risk of pregnancy. Keep using birth control for at least 3 weeks after your last dose of Iqirvo (elafibranor). This is important because the medication can harm an unborn baby.
- Let your care team know right away if you become pregnant while you're taking Iqirvo (elafibranor). You'll probably need to stop taking the medication because it can cause harm to an unborn baby.
Common questions about Iqirvo (elafibranor)
The FDA gave Iqirvo (elafibranor) an accelerated approval in June 2024 for treating primary biliary cholangitis (PBC) in adults. You can take Iqirvo together with ursodiol (Actigall), or also known as ursodeoxycholic acid. You can also take Iqirvo (elafibranor) by itself if you can’t take ursodiol (Actigall). This accelerated approval is a way for the FDA to bring Iqirvo (elafibranor) into the market quickly. This is important because people with PBC need more treatment options. Unmanaged PBC can lead to liver failure, which could possibly need a liver transplant. More research is needed to know for sure whether Iqirvo helps people with PBC live longer or prevent more liver damage.
A year-long study showed that Iqirvo (elafibranor) helped lower alkaline phosphatase (ALP) levels in most adults with PBC. ALP is a type of liver enzyme, and high ALP levels are typical for people with PBC. It's not clear or proven yet whether lower ALP levels actually helps people with PBC live longer or prevents more liver problems. Ask your prescriber if you have questions about how well the medication works and if it's right for you.
In a clinical study, Iqirvo (elafibranor) helped lower alkaline phosphatase (ALP) levels (a type of liver enzyme) within the first 4 weeks. ALP levels stayed lower for the rest of the year during the study. Keep in mind that it’s not clear what having lower ALP levels means for people with PBC yet. We don’t know yet if this helps people with PBC live longer or prevents more liver problems. Your prescriber will ask you to get blood tests done while you’re taking Iqirvo (elafibranor) to check your ALP levels. Talk to your prescriber about your test results.
In a study, around 20% of people who took Iqirvo (elafibranor) had weight gain. But almost the same percentage of people who took placebo also gained weight. So it's not clear if Iqirvo (elafibranor) is the cause. Keep in mind that people with severe, advanced PBC sometimes lose weight. So weight gain could be a sign that the liver condition is improving. Also note that a small number of people who took Iqirvo (elafibranor) reported weight loss in the study. Contact your prescriber if you notice unexplained changes in your weight while you're taking Iqirvo (elafibranor).
Hair loss wasn't a reported side effect of Iqirvo (elafibranor) in clinical studies. Contact your healthcare team if you notice hair loss, shedding, or thinning while you're taking Iqirvo (elafibranor). Your care team can help figure out what might be causing it.
Don’t breastfeed while you’re taking Iqirvo (elafibranor) and for at least 3 weeks after your last dose. There isn’t enough information about whether the medication passes into breast milk or whether it can harm your baby. If you’re breastfeeding or plan to nurse, talk to your prescriber or lactation consultant about safe feeding options.
Some people shouldn’t take Iqirvo (elafibranor) for safety reasons. Avoid taking Iqirvo (elafibranor) if you have moderate or severe liver problems, like severe cirrhosis. Also avoid it if you have a bile duct blockage (biliary obstruction). This medication might make your condition worse. People who are pregnant or breastfeeding also shouldn’t take Iqirvo (elafibranor). The medication might harm your baby. And talk to your prescriber if you’ve had muscle pain, bone fractures, or osteoporosis before. You might be more likely to have these side effects. Before starting Iqirvo (elafibranor), check with your prescriber to make sure it’s safe for you. There might be other options that are safer for you.
Iqirvo (elafibranor) and Livdelzi (seladelpar) work in similar ways to help adults with PBC. They’re both taken once daily and are options for those who’ve already tried ursodiol (Actigall). The two medications haven’t been directly compared to each other. But in the separate Iqirvo study and Livdelzi study, both lowered alkaline phosphatase (ALP) levels over a year. This could mean that the medications might help slow PBC, but more research is needed. In the Livdelzi study, the medication helped relieve itching, a common symptom of liver problems. But it wasn’t clear whether Iqirvo had a similar benefit in its own study. Also, muscle pain was a possible side effect of Iqirvo but wasn’t reported in the Livdelzi study. Talk to your prescriber to compare between Iqirvo and Livdelzi.
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Risks and warnings for Iqirvo (elafibranor)
Iqirvo (elafibranor) can cause some serious health issues. This risk may be even higher for certain groups. If this worries you, talk to your doctor or pharmacist about other options.
Muscle pain, weakness, and damage
- Risk factors: Taking other medications that can also cause muscle problems (e.g., statins)
Some people who took Iqirvo (elafibranor) had muscle pain and weakness. This can happen months after starting the medication. In a rare case, one person had a severe muscle problem called rhabdomyolysis, which led to kidney damage. The risk for muscle pain and damage might be higher if you take other medications that can also cause muscle damage (e.g., statins).
Let your care team know right away if you feel any new or worsening muscle pain, weakness, or tenderness while taking Iqirvo (elafibranor). And get medical attention if you have severe muscle pain or dark-colored urine. These can be signs of rhabdomyolysis.
Liver problems
- Risk factors: History of liver problems | Drinking large amounts of alcohol
Iqirvo (elafibranor) can sometimes cause injury to the liver. Some people who took this medication had elevated liver enzymes. This can mean that there’s stress or damage to the liver. Iqirvo (elafibranor) isn’t recommended for people with moderate or severe liver problems or advanced stages of cirrhosis.
You'll need blood tests before you start treatment so your prescriber can check your liver health. You’ll probably also need regular blood tests to check your liver as you take Iqirvo (elafibranor).
Get medical help right away if you have a swollen stomach, pain on the right side of your stomach, yellow skin or eyes, confusion, or changes in personality or mood. These can be signs of worsening liver damage. Your prescriber might tell you to stop taking Iqirvo (elafibranor) to prevent more liver damage.
Fractures
- Risk factors: History of fractures | Osteoporosis
In clinical studies, 6% of people taking Iqirvo (elafibranor) had a fracture (broken bone). Some fractures happened a few months after starting the medication. Tell your prescriber if you’ve broken a bone before or if you have osteoporosis. They might want to check your bone health during treatment with blood tests for calcium levels or bone density screenings (DEXA scan).
Get medical care right away if you think you’ve broken a bone. Signs include bruising, swelling, a bone looking “out of place,” or pain when you try to move a limb.
Risk of harm to a baby during pregnancy
Talk to your healthcare team if you're pregnant or thinking of becoming pregnant. You should avoid getting pregnant while you’re taking Iqirvo (elafibranor) and for at least 3 weeks after your last dose of the medication.
There aren’t any pregnancy studies done in people. But animal studies found that Iqirvo (elafibranor) might cause harm to an unborn baby if it’s taken during pregnancy. In the animal studies, there were harmful consequences, like loss of the baby and low body weight.
Before starting Iqirvo (elafibranor), take a pregnancy test as instructed to make sure you’re not pregnant. If you can become pregnant and are sexually active, use nonhormonal birth control, like Paragard (copper intrauterine device) or condoms, during treatment. If you prefer hormonal birth control, also use a barrier method like condoms. Iqirvo (elafibranor) can make hormonal birth control work less well and raise the risk of pregnancy. Keep using birth control for at least 3 weeks after your last dose of Iqirvo (elafibranor).
Avoid in people with biliary obstruction
- Risk factors: History of bile duct problems | Complete biliary obstruction
People with a complete bile duct blockage (biliary obstruction) should avoid taking Iqirvo (elafibranor). Call a healthcare professional right away if you have pain in the upper right side of your stomach belly or yellowing of your skin and eyes. These could be signs of a blockage. Your prescriber might ask you to stop taking Iqirvo (elafibranor) while they check and treat you for this blockage.
Iqirvo (elafibranor) dosage
Tablet| Dosage | Quantity | Price as low as | Price per unit |
|---|---|---|---|
| 80mg | 30 tablets | $11,612.65 | $387.09 |
Typical dosage for Iqirvo (elafibranor)
The typical dose is 80 mg (1 tablet) by mouth once per day.
How much does Iqirvo (elafibranor) cost?
$11,612.65
