Uses
What is Iqirvo used for?
Iqirvo (elafibranor) is commonly used to treat primary biliary cholangitis (PBC). PBC is a rare liver disease that occurs when your body’s immune system incorrectly attacks your bile ducts. Bile ducts are tubes that carry bile (a fluid that helps with digestion) out of the liver. Damage to the bile ducts can cause a backup of bile, which can lead to inflammation and damage to the liver.
Iqirvo may also be used for other conditions as determined by your healthcare provider.
How does Iqirvo work (mechanism of action)?
Iqirvo may work by blocking the formation of bile. This may help prevent a backup of bile. Bile buildup can lead to the liver damage that happens with PBC.
How is Iqirvo supplied (dosage forms)?
Iqirvo is available as 80 mg oral tablets that are taken by mouth.
How should I store Iqirvo?
Iqirvo should be stored at room temperature, between 59 F to 86 F (15 C to 30 C). Store in a cool, dry place. Keep Iqirvo in the original bottle and carton to protect it from moisture and light.
Side Effects
What are the most common side effects of Iqirvo?
The most common side effects of Iqirvo are listed below. Tell your healthcare provider if you have any of these side effects that bother you.
- Weight gain or loss
- Diarrhea, stomach pain, or constipation
- Nausea or vomiting
- Joint pain
- Muscle problems (see below)
- Acid reflux
- Bone fractures (see below)
- Dry mouth
- Rash
There may be other side effects of Iqirvo that are not listed here. Contact your healthcare provider if you think you are having a side effect of a medicine. In the U.S., you can report side effects to the FDA at www.fda.gov/medwatch or by calling 800-FDA-1088. In Canada, you can report side effects to Health Canada at www.health.gc.ca/medeffect or by calling 866-234-2345.
What are the serious side effects of Iqirvo?
While less common, the most serious side effects of Iqirvo are described below, along with what to do if they happen.
Severe Allergic Reactions. Iqirvo may cause allergic reactions, which can be serious. Stop taking Iqirvo and get help right away if you have any of the following symptoms of a serious allergic reaction.
- Breathing problems or wheezing
- Racing heart
- Fever or general ill feeling
- Swollen lymph nodes
- Swelling of the face, lips, mouth, tongue, or throat
- Trouble swallowing or throat tightness
- Itching, skin rash, or pale red bumps on the skin called hives
- Nausea or vomiting
- Dizziness, feeling lightheaded, or fainting
- Stomach cramps
- Joint pain
Muscle Problems. Iqirvo can cause muscle problems, including muscle pain, weakness, and tenderness called myopathy. In some people, the muscle may break down (rhabdomyolysis), which can be serious and rarely lead to kidney damage and death. Stop taking Iqirvo and get help right away if you have any of the following symptoms of myopathy or rhabdomyolysis.
- Unexplained muscle pain, weakness, or tenderness
- Low energy levels or feeling easily tired, especially with activity
- Dark-colored urine
- Fever
- Muscle cramps
- Stomach pain
- Nausea or vomiting
Bone Fractures. Iqirvo may increase your risk of having a fracture (broken bone). Tell your healthcare provider if you have new or unusual pain, changes in how well you can move around, or if you break a bone.
Liver Damage. Liver damage, also called hepatotoxicity, can happen when taking Iqirvo. Call your healthcare provider right away if you have any of the following symptoms of liver damage.
- Nausea or vomiting
- Stomach or belly pain
- Fluid retention or swelling in the stomach, legs, or feet
- Your skin or the whites of your eyes turning yellowish in color (also called jaundice)
- Fever
- Weakness or unusual tiredness
- Itching
- Loss of appetite
- Black or tarry stools
- Coughing up or vomiting blood, or vomit that looks like coffee grounds
- Confusion, mood swings, or being sleepier than usual
- Dark-colored urine
Blocked Bile Duct. Iqirvo may increase your risk of gallstones. It should not be used if your bile ducts are blocked, also called biliary obstruction. Call your healthcare provider right away if you have any of the following symptoms of gallstones or biliary obstruction.
- Pain in your upper stomach area
- Fever
- Stool (poop) that is clay-colored
- Your skin or the whites of your eyes turning yellowish in color (also called jaundice)
Warnings & Precautions
Who should not use Iqirvo?
Allergies to Ingredients. People who are allergic to any of the following should not take Iqirvo.
- Elafibranor
- Iqirvo
- Any of the ingredients in the specific product dispensed
Your pharmacist can tell you all of the ingredients in Iqirvo.
Severe Liver Problems. Iqirvo should not be used if you have or develop severe liver disease, such as advanced cirrhosis. Your healthcare provider may do tests to determine if your liver is working well enough to take this medicine. You should also tell your healthcare provider right away if you have symptoms of worsening liver problems, such as swelling due to fluid buildup in your stomach, confusion or excessive sleepiness, or your skin or the whites of your eyes turning yellowish in color.
What should I know about Iqirvo before using it?
Do not take Iqirvo unless it has been prescribed to you by a healthcare provider. Take it as prescribed.
Do not share Iqirvo with other people, even if they have the same condition as you. It may harm them.
Keep Iqirvo out of the reach of children.
What should I tell my healthcare provider before using Iqirvo?
Tell your healthcare provider about all of your health conditions and any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using. This will help them determine if Iqirvo is right for you.
In particular, make sure that you discuss any of the following.
Current and Past Health Conditions. Tell your healthcare provider if you have any of the following.
- Severe liver problems
- Weak bones or have broken a bone
- Muscle pain, weakness, or other muscle problems
Other Medicines and Supplements. Iqirvo may interact with other medicines and supplements. Before taking Iqirvo, tell your healthcare provider about any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using. See the Interactions section for more details.
Pregnancy. Iqirvo may cause harm to an unborn baby. Tell your healthcare provider if you are or plan to become pregnant. You must not be pregnant before starting Iqirvo. If you can become pregnant, use effective birth control while you are taking Iqirvo and for 3 weeks after your last dose. You should either use effective non-hormonal birth control, or if you take hormonal birth control (such as the pill), you should also add a barrier method (such as condoms).
There is a Pregnancy Safety Study that monitors the health of you and your unborn baby if you become pregnant while taking Iqirvo. If you become or think you might be pregnant while taking Iqirvo, you or your healthcare provider should report your pregnancy by calling 855-463-5217 or visiting www.ipsen.com/contact-us.
Breastfeeding. It is not known if Iqirvo passes into breast milk. Do not take Iqirvo while you are breastfeeding and for 3 weeks after your last dose. Tell your healthcare provider if you are breastfeeding or plan to breastfeed.
How can I get more information about Iqirvo?
For more information about Iqirvo, you can visit the manufacturer’s website at www.ipsencares.com/iqirvo-patient-support or www.ipsen.com/contact-us, or call them at 855-463-5127.
Interactions
Does Iqirvo interact with foods or drinks?
There are no known interactions between Iqirvo and foods or drinks.
It is unknown if drinking alcohol will affect Iqirvo.
Does Iqirvo interact with other medicines (drug interactions)?
Always tell your healthcare provider about any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using.
In particular, make sure that you discuss if you are using any of the following before taking Iqirvo.
- A birth control pill, patch, vagin*l ring, implant, injection, or intrauterine device (IUD)
- A statin, such as atorvastatin (Lipitor and others) or rosuvastatin (Crestor and others), which is a medicine to lower cholesterol
- A bile acid sequestrant, such as colestipol (Colestid), cholestyramine, or colesevelam (Welchol), which is a medicine to lower cholesterol
- Rifampin, which is a medicine commonly used to treat an infection called tuberculosis
Some other medicines may alter the blood levels of Iqirvo, and vice versa. Tell your healthcare provider about all medicines that you take or have recently taken.
This may not be a complete list of medicines that can interact with Iqirvo. Always check with your healthcare provider.
Does Iqirvo (elafibranor) interact with other drugs you are taking?
Enter your medication into the WebMD interaction checker
Overdose/Missed Dose
What should I do if I accidentally use too much Iqirvo?
If you or someone else has used too much Iqirvo, get medical help right away, call 911, or contact a Poison Control center at 800-222-1222.
What should I do if I miss a dose of Iqirvo?
If you miss a dose, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose and only take the next dose. Do not take double or extra doses.
