IQIRVO 80 mg film-coated tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Iqirvo 80 mg film-coated tablets

elafibranor

This medicinal product is subject to additional monitoring, which will allow rapid identification of new information on its safety. You can help by reporting any side effects you may experience. Information on how to report side effects is included at the end of section 4.

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

• Keep this leaflet, as you may need to read it again.

• If you have any questions, consult your doctor or pharmacist.

• This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you, because it could harm them.

  • If you experience any side effects, consult your doctor or pharmacist, even if they are side effects not listed in this leaflet. See section 4.

Leaflet contents

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

1. What Iqirvo is and what it is 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 fluid that helps digest food, especially fats. When bile cannot flow into the digestive tract, it accumulates in the liver (a condition known as cholestasis), where it damages liver tissue. This can reduce liver function and cause inflammation. Iqirvo can be used together with ursodeoxycholic acid (UDCA), or alone in patients who cannot take UDCA.

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

2. What you need to know before taking Iqirvo

Do not take Iqirvo

• if you are allergic to elafibranor or to any of the other components of this medicine (listed in section 6).
• if you are pregnant, think you might be pregnant, or if you 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 may perform blood tests to monitor your liver before and during treatment. If these liver test results are abnormal, your doctor may temporarily stop treatment until they return to normal. Immediately inform your doctor if you experience symptoms of liver dysfunction, such as yellowing of the skin or eyes (jaundice), abdominal pain, discomfort, vomiting, fatigue, loss of appetite, or 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 monitor 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, or rosuvastatin. Consult your doctor immediately if you experience unexplained muscle pain, swelling, 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

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

Pregnancy

Do not take Iqirvo if you are pregnant, think you might be pregnant, or if you 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.

If you are a woman of childbearing potential, you must use an effective contraceptive method while taking this medicine and for at least 3 weeks after stopping it to avoid harm to the fetus. Your doctor will advise you on the most suitable contraceptive method for you.

Breastfeeding

It is unknown whether Iqirvo passes into breast milk. Risk to the breastfed infant cannot be excluded.

You must not breastfeed 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; essentially, it is "sodium-free".

3. How to take Iqirvo

Follow exactly your doctor's instructions on how to take this medicine. If you are unsure, consult your doctor or pharmacist again.

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

Consult 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 prescribed, speak to your doctor or go immediately to the hospital, taking the tablets 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 at the scheduled time.

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

If you stop taking Iqirvo

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

If you have any further questions about using this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone experiences them.

Possible adverse effects are:

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

• Stomach ache (abdominal pain)
• Diarrhoea
• Feeling unwell (nausea)
• Vomiting

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

• Headache
• Constipation
• Gallstones (cholelithiasis) which may block the flow of bile causing abdominal pain, nausea or vomiting
• Increase in creatine phosphokinase, detected in blood tests
• Muscle pain (myalgia)

Uncommon adverse effects (may affect 1 in 100 people):

• Itchy skin rash (pruritic eruption)
• Increase in creatinine, detected in blood tests. Blood creatinine levels are measured to monitor kidney function.

Reporting of adverse effects

If you experience any adverse effects, consult your doctor, even if they are adverse effects not listed in this leaflet. You can also report them directly through the national reporting system included in Appendix V*. By reporting adverse 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 stated on the label of the bottle and the outer carton following "EXP". The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage conditions.

Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Iqirvo

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

The other components are:

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

Appearance of the product and pack contents

Iqirvo 80 mg are orange, round, film-coated tablets approximately 8 mm in diameter, marked with "ELA 80" on one side.

Iqirvo is available in bottles containing 30 film-coated tablets, with 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

Further information on this medicinal product is available upon request from the local representative of the Marketing Authorisation Holder:

Date of the most recent review of this leaflet

This medicinal product has been authorised under a "conditional approval". This type of approval means that further information on this medicinal product is expected.

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

Other sources of information

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