MEDICATION GUIDE
IQIRVO® (eye-ker-vo)
(elafibranor) tablets |
What is IQIRVO?
IQIRVO is a prescription medicine used to treat primary biliary cholangitis (PBC) in combination with ursodeoxycholic acid (UDCA) in adults who have not responded well to UDCA, or used alone in patients unable to tolerate UDCA.
IQIRVO is not recommended for use in people who have symptoms or signs of advanced liver disease (decompensated cirrhosis) including confusion; having fluid in the stomach-area (abdomen); black, tarry, or bloody stools; coughing up or vomiting blood, or having vomit that looks like "coffee grounds."
It is not known if taking IQIRVO will improve your chance of survival or prevent liver decompensation.
It is not known if IQIRVO is safe and effective in children under 18 years of age. |
Before taking IQIRVO, tell your healthcare provider about all of your medical conditions, including if you:
- have advanced liver disease.
- are pregnant or plan to become pregnant. IQIRVO can harm your unborn baby. You should not become pregnant during treatment with IQIRVO.
Pregnancy Safety Study. If you become pregnant while receiving IQIRVO, tell your healthcare provider right away. There is a pregnancy safety study for women who become pregnant while taking IQIRVO. Talk to your healthcare provider about providing information to the IQIRVO pregnancy safety study. The purpose of this study is to collect information about your health and your baby's health. You or your healthcare provider can report your pregnancy by calling 1-855-463-5217 or visiting https://www.ipsen.com/contact-us/.
- are breastfeeding or plan to breastfeed. It is not known if IQIRVO passes into your breast milk. Do not breastfeed while taking IQIRVO and for 3 weeks after the last dose of IQIRVO. Talk with your healthcare provider about the best way to feed your baby if you take IQIRVO.
Your healthcare provider should check for muscle pain or weakness before your start taking IQIRVO. Tell your health care provider right away If you have new and/or severe muscle pain or muscle weakness.
Females who can become pregnant:
- You should use effective birth control during treatment and for 3 weeks after the last dose of IQIRVO. Talk to your healthcare provider about birth control methods that may be right for you.
- Tell your healthcare provider right away if you become pregnant or think you may be pregnant.
Tell your healthcare provider about all of the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. IQIRVO can affect the way certain medicines work. Certain medicine may affect the way IQIRVO works. |
How should I take IQIRVO?
- Take IQIRVO exactly as your healthcare provider tells you to.
- Take IQIRVO with or without food.
- If you take a bile acid binding resin, take IQIRVO at least 4 hours before or 4 hours after you take your bile acid binding resin. If this is not possible, space the time between taking IQIRVO and your bile acid binding resin as far apart as possible.
- If you take too much IQIRVO, call your healthcare provider or get emergency medical help right away.
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What are the possible side effects of IQIRVO?
IQIRVO can cause serious side effects including:
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Muscle problems (myalgia, myopathy, rhabdomyolysis). IQIRVO can cause muscle pain that can be severe. Treatment with IQIRVO may cause muscle pain or worsen existing pain and can increase the level of an enzyme in your blood called creatine phosphokinase (CPK); both can be a sign of muscle damage. Your healthcare provider should test for muscle weakness or pain before and during treatment. If there is new onset or worsening of muscle pain then your healthcare provider may examine you and perform a blood test to check your levels of creatine phosphokinase (CPK). Stop taking IQIRVO and call your healthcare provider right away if you have any of the following signs or symptoms:
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- severe muscle pain
- unexplained soreness
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- unexplained muscle weakness
- dark, reddish urine
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Bone fractures. Taking IQIRVO may increase your risk of bone fractures. Tell your healthcare provider about any bone fractures, or if you develop pain, or have changes in your ability to move around.
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Liver problems. IQIRVO may cause abnormal liver blood test results. Your healthcare provider should do tests before starting and during treatment with IQIRVO to check your liver function.
Tell your healthcare provider right away if you have any of the following signs or symptoms of worsening liver problems, during treatment with IQIRVO:
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- swelling of your stomach-area (abdomen) from a build-up of fluid
- yellowing of your skin or the whites of your eyes
- black, tarry, or bloody stools
- coughing up or vomiting blood, or your vomit looks like "coffee grounds"
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- mental changes such as confusion, being sleepier than usual or harder to wake up, slurred speech, mood swings, or changes in personality
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| Tell your healthcare provider right away if you have any of the following symptoms during treatment with IQIRVO and they are severe or do not go away: |
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- stomach-area (abdomen) pain
- nausea, vomiting, diarrhea
- loss of appetite or weight loss
- new or worsening fatigue
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- weakness
- fever and chills
- light-headedness
- less frequent urination
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Allergic reactions. Some people taking IQIRVO have had allergic reactions. The reactions happened 2 to 30 days after taking IQIRVO. Allergic reaction symptoms may include:
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- itching
- swelling of your face, lips, tongue, or throat.
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| If you have any of these symptoms stop taking IQIRVO and call your healthcare provider right away or go to the nearest hospital emergency room. |
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Blockage of the bile duct. Taking IQIRVO may increase your risk of gallstone development. Call your healthcare provider right away if you develop any signs or symptoms of gallstones, including pain in upper right stomach area or yellowing of the skin.
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| The most common side effects of IQIRVO include: |
- weight gain
- diarrhea
- nausea and vomiting
- joint pain
- stomach pain
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- constipation
- muscle problems
- bone fractures
- gastroesophageal reflux disease (GERD)
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- dry mouth
- weight loss
- rash
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Your healthcare provider may tell you to stop taking IQIRVO temporarily or permanently if there are changes to either your liver tests or the level of an enzyme in your blood related to muscle activity called creatine phosphokinase (CPK).
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. |
How should I store IQIRVO?
- Store IQIRVO at room temperature between 15°C to 30°C (59°F to 86°F).
- Store in the original package (bottle and carton) to protect from moisture and light.
Keep IQIRVO and all medicines out of the reach of children. |
General information about the safe and effective use of IQIRVO.
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use IQIRVO for a condition for which it was not prescribed. Do not give IQIRVO to other people even if they have the same symptoms that you have. It may harm them. You can ask your pharmacist or healthcare provider for information about IQIRVO that is written for health professionals. |
What are the ingredients in IQIRVO?
Active ingredient: Elafibranor
Inactive ingredients: colloidal silica dioxide, croscarmellose sodium, magnesium stearate, microcrystalline cellulose, and povidone. The film coating consists of: iron oxide red, iron oxide yellow, polyethylene glycol, polyvinyl alcohol, talc, and titanium dioxide.
Manufactured for: Ipsen Biopharmaceuticals, Inc., One Main Street, 7th Floor, Cambridge, MA, 02142, USA
For more information, 1-855-463-5127
IQIRVO is a registered trademark of Genfit SA
© 2024 Ipsen Biopharmaceuticals, Inc. All rights reserved |