IQIRVO 80 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the Patient

Iqirvo 80mg film-coated tablets

elafibranor

This medicinal product is subject to additional monitoring, which will allow for the quick identification of new safety information. You can help by reporting any side effects you may get. The last section of section 4 will tell you how to report side effects.

Read all of this leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.

• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What is Iqirvo and what is it used for
2. What you need to know before you take Iqirvo
3. How to take Iqirvo
4. Possible side effects
5. Storage of Iqirvo
6. Contents of the pack and other information

1. What is Iqirvo and what is it used for

Iqirvo contains the active substance elafibranor, which acts on two types of receptors (PPAR alpha and PPAR delta).

This medicine is used in adults to treat primary biliary cholangitis (PBC), a type of liver disease in which the bile ducts are slowly destroyed, making it difficult for bile to flow. Bile is a liquid that helps digest food, especially fats. When bile cannot flow into the digestive tract, it builds up in the liver (a condition called cholestasis), where it damages liver tissue. This can reduce liver function and cause inflammation. Iqirvo can be used alone or in combination with ursodeoxycholic acid (UDCA) in patients who cannot use UDCA.

The active substance in Iqirvo, elafibranor, works by activating PPAR alpha and PPAR delta receptors. These proteins are thought to regulate bile acid levels, inflammation, and fibrosis (scarring). This reduces the production and accumulation of bile in the liver and also reduces liver inflammation.

2. What you need to know before you take Iqirvo

Do not take Iqirvo

• if you are allergic to elafibranor or any of the other ingredients of this medicine (listed in section 6).
• if you are pregnant, think you may be pregnant or are not using any contraceptive method to prevent pregnancy.

Warnings and precautions

Iqirvo may increase blood levels of liver enzymes and bilirubin (a breakdown product of red blood cells). Your doctor will perform blood tests to check your liver before and during treatment. If the results of these liver tests are abnormal, your doctor may temporarily stop treatment until they return to normal. Tell your doctor immediately if you experience symptoms of liver dysfunction, such as yellowing of the skin and eyes (jaundice), abdominal pain, nausea, vomiting, fatigue, loss of appetite, and dark urine.

Iqirvo may increase blood levels of creatine phosphokinase (an enzyme released into the blood when muscle is damaged). Your doctor will perform blood tests to check your creatine phosphokinase levels before and during treatment, especially if you are taking medicines known as HMG-CoA reductase inhibitors, such as atorvastatin, fluvastatin, pitavastatin, pravastatin, rosuvastatin. Tell your doctor immediately if you experience unexplained muscle pain, inflammation, or weakness while taking this medicine.

Children and adolescents

This medicine must not be used in children and adolescents under 18 years of age.

Other medicines and Iqirvo

Tell your doctor if you are taking, have recently taken or might take any other medicines.

Pregnancy

Do not take Iqirvo if you are pregnant, think you may be pregnant or are not using any contraceptive method to prevent pregnancy. Iqirvo may harm the fetus.

Your doctor may perform a pregnancy test before starting treatment with Iqirvo to ensure you are not pregnant before starting it.

If you are a woman of childbearing potential, you must use an effective contraceptive method (birth control) while taking this medicine and for at least 3 weeks after stopping treatment to prevent harm to the fetus. Your doctor will advise you on the best contraceptive method for you.

Breast-feeding

It is not known if Iqirvo passes into breast milk. The risk to the breast-fed child cannot be excluded.

Do not breast-feed your baby during treatment and for 3 weeks after the last dose.

Iqirvo contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per tablet, which is essentially 'sodium-free'.

3. How to take Iqirvo

Take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.

The recommended dose is one 80 mg tablet once a day. Swallow the tablets whole with water.

Ask your doctor before taking Iqirvo if you have advanced cirrhosis (a type of chronic and progressive liver disease in which liver cells are replaced by scar tissue) with severely reduced liver function (Child-Pugh C).

If you take more Iqirvo than you should

If you take more medicine than you should, talk to your doctor or go to the hospital immediately, taking the medicine pack and this leaflet with you.

If you forget to take Iqirvo

If you forget to take a dose of Iqirvo, skip the missed dose and take the next dose when it is due.

Do not take a double dose to make up for a forgotten dose.

If you stop taking Iqirvo

Do not stop taking this medicine without talking to your doctor first.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

The possible side effects are:

Very common side effects (may affect more than 1 in 10 people):

• Abdominal pain
• Diarrhea
• Nausea
• Vomiting

Common side effects (may affect up to 1 in 10 people):

• Headache
• Constipation
• Gallstones (cholelithiasis) that can block the flow of bile, causing abdominal pain, nausea, or vomiting
• An increase in creatine phosphokinase, measured in blood tests
• Muscle pain (myalgia)

Uncommon side effects (may affect up to 1 in 100 people):

• Itchy skin rash (pruriginous rash)
• An increase in creatinine, measured in blood tests. Creatinine levels in the blood are measured to monitor kidney function.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V*. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Iqirvo

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton and blister after EXP. The expiry date refers to the last day of the month shown.

This medicine does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Iqirvo contains

• The active substance is elafibranor.
• Each film-coated tablet contains 80 mg of elafibranor.

The other ingredients are:

• Tablet core:microcrystalline cellulose, povidone, sodium croscarmellose (see section 2 'Iqirvo contains sodium'), colloidal anhydrous silica, magnesium stearate.
• Film coating:partially hydrolyzed polyvinyl alcohol, titanium dioxide (E171), macrogol, talc, yellow iron oxide (E172), red iron oxide (E172).

Appearance and packaging

Iqirvo 80 mg are film-coated tablets, round and orange in color, approximately 8 mm in diameter, and identified with 'ELA 80' on one side.

Iqirvo is available in packs of 30 film-coated tablets, with a child-resistant closure.

Marketing Authorisation Holder

Ipsen Pharma

70 rue Balard

75015 Paris

France

Manufacturer

Delpharm Milano Srl

Via Salvatore Carnevale 1

Segrate, 20054

Italy

You can request more information about this medicine from the local representative of the Marketing Authorisation Holder:

Date of last revision of this leaflet

This medicine has been authorized with a 'conditional approval'. This type of approval means that more information on this medicine is expected.

The European Medicines Agency will review the new information on this medicine at least once a year and this leaflet will be updated as necessary.

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu. There are also links to other websites on rare diseases and orphan medicines.