Iqirvo

Iqirvo is used to treat primary biliary cholangitis (PBC), a chronic liver disease, in adults. It is taken once daily in combination with ursodiol (ursodeoxycholic acid, UDCA) or alone in patients who cannot tolerate ursodiol.

Primary biliary cholangitis (PBC) is a chronic autoimmune liver disease in which the bile ducts become progressively damaged, leading to bile buildup, liver inflammation, and, over time, potential liver scarring (cirrhosis). It predominantly affects women over 40.

It is not known if taking Iqirvo will improve your chance of survival or prevent liver decompensation.

Iqirvo (elafibranor) received FDA approval on June 10, 2024, making it the first new treatment for primary biliary cholangitis approved in nearly a decade. It was approved under the accelerated approval pathway based on reductions in alkaline phosphatase levels. There is no generic.

The cost of Iqirvo for PBC depends on the type of insurance plan you have and if you are eligible for Copay assistance. Some people may pay as little as $0 for each Iqirvo prescription. To determine eligibility, contact the Ipsen Cares patient support program.

For more information about Iqirvo's cost, see Iqirvo Prices, Coupons, Copay Cards & Patient Assistance.

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.

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.

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”.

Pregnancy

Iqirvo can harm your unborn baby. You should not become pregnant during treatment. Females who can become pregnant should use an effective method of birth control, such as progestin-only contraceptives containing levonorgestrel or norgestrel, intrauterine systems, or effective non-hormonal contraceptives while taking Iqirvo and for 3 weeks after the last dose. 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 registry 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 1-844-990-0239 or visiting www.iqirvopregnancyregistry.com.

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.

Common Side Effects

The most common side effects of Iqirvo are:

• 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 the following serious side effects:

• Muscle pain or worsen existing muscle pain. This could be a sign of muscle damage. Your doctor should check for muscle problems before and during treatment. If you develop new or worsening muscle pain, contact your doctor right away. They may do 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, or dark, reddish urine.
• An increased 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.
• 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. These 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.
• Increased 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.

Iqirvo 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 levels of creatine phosphokinase (CPK) in your blood (this enzyme relates to muscle activity).

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

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.

If you take too much Iqirvo, call your healthcare provider or get emergency medical help right away.

Iqirvo works by targeting a group of receptors in the body known as PPARs (peroxisome proliferator-activated receptors). These receptors play an important role in regulating the body's energy balance and metabolic processes. By activating two specific types, PPAR-alpha and PPAR-delta, Iqirvo helps reduce the liver's production of bile acids, which is believed to ease the damage caused by bile buildup in PBC. However, the precise way the drug produces its beneficial effects in PBC patients is not yet fully understood.

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 birth control methods (such as pills, shots, patches, and implants). These may not work as well when taken with Iqirvo. You should use an effective method of birth control, such as progestin-only contraceptives containing levonorgestrel or norgestrel, intrauterine systems, or effective non-hormonal contraceptives while taking Iqirvo and for at least 3 weeks after the last dose.
• 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 binding resins, 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.
• Medicines called PPAR-alpha agonists (such as fenofibrate or fenofibric acid) or PPAR-gamma agonists (such as pioglitazone or rosiglitazone). Taking these medicines with Iqirvo may increase your risk of muscle or liver injury.

This is not a complete list of interactions. Talk to your healthcare provider or see the Iqirvo Package Insert for a full list.

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.

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.

Ipsen Biopharmaceuticals, Inc. makes Iqirvo.