Iqirvo
Pronunciation: eye-ker-vo
Generic name: elafibranor
Dosage form: oral tablet
What is Iqirvo?
Iqirvo (elafibranor) is an oral, once-daily, tablet that may be 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 people with symptoms or signs of advanced liver disease (decompensated cirrhosis) including confusion; fluid in the stomach area (abdomen); black, tarry, or bloody stools; coughing up or vomiting blood, or having vomit that looks like “coffee grounds”.
Iqirvo and its main active metabolite are peroxisome proliferator-activated receptor (PPAR) agonists and work by activating PPAR receptors, which are a family of receptors that play a main regulatory role in energy homeostasis and metabolic function. Iqirvo activates PPAR-alpha and PPAR-delta, blocking the production of bile acids, although the exact way it works in patients with PBC is not well understood.
Iqirvo was FDA-approved on 10 June 2024 under the accelerated approval designation, making it the first new medicine approved in nearly a decade for PBC. Continued approval may be contingent on a positive clinical benefit in further clinical trials.
Approval is based on reducing alkaline phosphatase (ALP), with no increases in liver toxicity. Improvement in survival or prevention of liver decompensation events has not been demonstrated.
Iqirvo side effects
The most common side effects reported in ≥5% of people taking Iqirvo were:
- weight gain
- abdominal pain
- diarrhea
- nausea and vomiting.
- constipation
- dry mouth
- muscle problems
- weight loss
- bone fractures
- rash
- joint pain
- stomach pain
- gastroesophageal reflux disease (GERD).
Serious side effects and warnings
Iqirvo can cause other serious side effects including:
Muscle problems (myalgia, myopathy, rhabdomyolysis). 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 a new onset or worsening of muscle pain, then your healthcare provider may examine you and perform a blood test to check your creatine phosphokinase (CPK) levels. Stop taking Iqirvo and call your healthcare provider right away if you have any of the following signs or symptoms:
- severe muscle pain
- unexplained muscle weakness
- unexplained soreness
- dark, reddish urine.
Bone fractures. Taking Iqirvo may increase your risk of bone fractures. Tell your healthcare provider about any bone fractures, if you develop pain, or have changes in your ability to move around.
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:
- swelling of your stomach area (abdomen) from a build-up of fluid
- mental changes such as confusion, being sleepier than usual or harder to wake up, slurred speech,
- yellowing of your skin or the whites of your eyes
- mood swings, or changes in personality
- black, tarry, or bloody stools
- coughing up or vomiting blood, or your vomit looks like “coffee grounds”
Allergic reactions have occurred in some people taking Iqirvo. The reactions happened 2 to 30 days after taking it and included symptoms such as rash, itching, trouble breathing, and swelling of your face, lips, tongue, or throat. 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.
Taking Iqirvo may increase your risk of gallstone development and bile duct blockage. Call your healthcare provider right away if you develop any signs or symptoms of gallstones, including pain in the upper right stomach area or yellowing of the skin
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:
- stomach-area (abdomen) pain
- weakness
- nausea, vomiting, diarrhea
- fever and chills
- loss of appetite or weight loss
- light-headedness
- new or worsening fatigue
- less frequent urination.
May cause harm to an unborn baby. If you are a female with the ability to become pregnant, your healthcare provider may conduct a pregnancy test before prescribing Iqirvo.
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 the FDA at 1-800-FDA-1088.
Related/similar drugs
ursodiol, Ocaliva, Actigall
Before taking
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
- are breastfeeding or plan to breastfeed.
Your healthcare provider should check for muscle pain or weakness before you start taking Iqirvo. Tell your healthcare provider right away If you have new and/or severe muscle pain or muscle weakness.
It is not known if Iqirvo is safe and effective in children under 18 years of age.
Pregnancy
Iqirvo can harm your unborn baby. You should not become pregnant during treatment. Females who can become pregnant 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.
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, the purpose of which 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/.
Breastfeeding
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. Talk with your healthcare provider about the best way to feed your baby if you take Iqirvo.
How should I take Iqirvo?
Take Iqirvo exactly as your healthcare provider tells you to.
- The usual Iqirvo dosage is 80 mg once daily.
- Iqirvo may be taken with or without food.
If you take a bile acid binding resin (such as cholestyramine or colestipol), 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.
Your healthcare provider will monitor your liver function while you are being treated with Iqirvo and may adjust or discontinue treatment if you have evidence of liver toxicity or decompensated cirrhosis.
What happens if I miss a dose?
If you miss a dose of Iqirvo, take the dose as soon as you remember. If it is almost time for your next dose, skip the missed dose and go back to your usual dosing schedule. Do not double up on doses.
What happens if I overdose?
If you take too much Iqirvo, call your healthcare provider or get emergency medical help right away.
What other drugs will affect Iqirvo?
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. Especially tell your healthcare provider if you take:
- Hormonal contraceptives (birth control pills). You will need to switch to effective non-hormonal contraceptives or add a barrier method when using hormonal contraceptives and for at least 3 weeks after the last dose of Iqirvo
- HMG-CoA reductase inhibitors (also called statins, such as atorvastatin, pravastatin, or lipostatin). Your healthcare provider will need to monitor you for signs and symptoms of muscle injury
- Rifampin. Your healthcare provider will need to monitor liver enzymes such as alkaline phosphatase and bilirubin if you start taking rifampin during Iqirvo treatment
- Bile acid sequestrants, such as cholestyramine or colestipol. Iqirvo should be taken at least 4 hours before or 4 hours after a bile acid binding sequestrant, or at as great an interval as possible.
This is not a complete list of interactions. Talk to your healthcare provider or see the Iqirvo Package Insert for a full list.
Storage
Store at room temperature between 15°C to 30°C (59°F to 86°F) in the original package (bottle and carton) to protect from moisture and light.
Keep out of the reach of children.
Iqirvo ingredients
Active ingredient: elafibranor
Inactive ingredients: colloidal silica dioxide, croscarmellose sodium, magnesium stearate, microcrystalline cellulose, and povidone.
Film coating: iron oxide red, iron oxide yellow, polyethylene glycol, polyvinyl alcohol, talc, and titanium dioxide.
Manufacturer
Ipsen Biopharmaceuticals, Inc.
References
More about Iqirvo (elafibranor)
Professional resources
Related treatment guides
Further information
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
