Lyvdelzi 10 mg hard capsules

Patient Information Leaflet

Introduction

Package leaflet: Information for the patient

Lyvdelzi 10 mg hard capsules

seladelpar

This medicinal product is subject to additional monitoring, which will allow for faster identification of new safety information. You can help by reporting any adverse reactions you may experience. Information on how to report adverse reactions is provided at the end of section 4.

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

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not pass it on to other people, even if they have the same symptoms as you, since it may harm them.
• If you experience any adverse reactions, consult your doctor, pharmacist, or nurse, even if they are adverse reactions not listed in this leaflet. See section 4.

Contents of this leaflet

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

1. What Lyvdelzi is and what it is used for

What Lyvdelzi is

Lyvdelzi contains the active substance seladelpar. It belongs to a group of medicines known as peroxisome proliferator-activated receptor delta agonists.

This medicine is used in adults to treat primary biliary cholangitis (PBC), a 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 pass into the digestive tract, it accumulates in the liver (this is called cholestasis), damaging liver tissue. This can reduce liver function and lead to inflammation. Lyvdelzi can be used in combination with ursodeoxycholic acid (UDCA) or as monotherapy in patients who do not tolerate UDCA.

The active substance in Lyvdelzi, seladelpar, works by activating the PPAR delta receptor. This protein regulates bile acid levels, inflammation, and fibrosis (scar tissue formation). This reduces the production and accumulation of bile in the liver and also decreases liver inflammation.

2. What Lyvdelzi is and what it is used for

Do not take Lyvdelzi:

• if you are allergic to seladelpar or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Your doctor may carry out blood tests before you start treatment with Lyvdelzi and during treatment to check whether your liver is functioning properly (liver function). If the tests show that your liver function has worsened, your doctor may need to interrupt treatment. If your liver recovers, treatment may be restarted. However, if your liver function worsens again after restarting treatment, your doctor may permanently discontinue treatment with Lyvdelzi. Contact your doctor immediately if you develop symptoms of liver dysfunction (liver inflammation) or complete biliary obstruction (blocked bile ducts) during treatment, including:

• abdominal pain
• jaundice (yellowing of the skin and whites of the eyes)
• dark urine
• pale stools

Children and adolescents

Lyvdelzi must not be given to children and adolescents under 18 years of age.

Other medicines and Lyvdelzi

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

In particular, inform your doctor, pharmacist, or nurse if you are taking a medicine called:

• Probenecid, used to treat gout
• Cyclosporine, used to prevent rejection of a transplanted organ
• "Bile acid sequestrants" (such as cholestyramine, colestipol, or colesevelam), used to lower blood cholesterol levels. These may reduce the effectiveness of Lyvdelzi if taken too close in time to Lyvdelzi.
• If you take a "bile acid sequestrant", you must take Lyvdelzi at least 4 hours before or at least 4 hours after taking the "bile acid sequestrant". See section 3 for more information.

The following medicines may increase the risk of adverse effects with Lyvdelzi, as they increase the amount of Lyvdelzi in the blood:

• Fluconazole, used to treat fungal infections
• Mifepristone, used for medical termination of pregnancy

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

Driving and using machines

This medicine is unlikely to affect your ability to drive, ride a bicycle, or use tools or machinery.

Lyvdelzi contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per hard capsule; i.e., essentially "sodium-free".

3. How to take Lyvdelzi

Follow exactly the instructions for using this medicine given by your doctor, pharmacist, or nurse. If in doubt, consult your doctor, pharmacist, or nurse again.

How much to take

The recommended dose is one 10 mg capsule once daily.

How to take it

• Swallow the capsule whole with water
• You may take this medicine with or without food
• Lyvdelzi is taken together with another medicine called «ursodeoxycholic acid» (UDCA, also known as ursos or ursodiol), or alone if you cannot take UDCA

If you are already taking a bile acid sequestrant resin:

• Take Lyvdelzi at least 4 hours before or at least 4 hours after taking the bile acid sequestrant resin
• If in doubt, ask your doctor, pharmacist, or nurse

If you take more Lyvdelzi than you should

If you take more Lyvdelzi than you should, inform your doctor, pharmacist, or nurse immediately.

Symptoms of overdose may include dark urine or muscle pain.

If you forget to take Lyvdelzi

If you forget to take Lyvdelzi, skip the missed dose and take the next dose at the usual time.

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

If you stop taking Lyvdelzi

Do not stop taking this medicine without consulting your doctor, pharmacist, or nurse.

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

4. Possible adverse effects

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

Adverse effects

Inform your doctor, pharmacist, or nurse if you notice any of the following adverse effects.

Very common: may affect more than 1 in 10 people

• abdominal pain

Common: may affect up to 1 in 10 people

• headache
• nausea
• bloating (abdominal distension)

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You may 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 Lyvdelzi

Keep this medicine out of sight and reach of children.

Do not use this medicine after the expiry date stated on the vial after "EXP". The expiry date refers to the last day of the month indicated.

Do not store this medicine above 30 °C.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and packaging you no longer need. This helps protect the environment.

6. Contents of the pack and other information

Composition of Lyvdelzi

• The active substance is seladelpar.

• Each Lyvdelzi hard capsule contains 10 mg of seladelpar.

• The other components are:

• Capsule contents: microcrystalline cellulose, mannitol, sodium croscarmellose, butylhydroxytoluene, magnesium stearate, colloidal silicon dioxide

• Capsule shell: gelatin, titanium dioxide, black iron oxide (E172), red iron oxide (E172), yellow iron oxide (E172), indigo carmine (E132)

• Black ink used to print "10" on the body of the capsule: shellac (E904), propylene glycol (E1520), potassium hydroxide (E525), black iron oxide (E172)

• White ink used to print "CBAY" on the capsule cap: shellac (E904), propylene glycol (E1520), sodium hydroxide (E524), povidone (E1201), titanium dioxide

Do not take Lyvdelzi if you are allergic to any of the components listed in section 2.

Appearance of the product and contents of the pack

This medicine is a hard capsule with an opaque dark blue cap and an opaque light grey body, printed with "CBAY" in white ink on the cap and "10" in black ink on the body. The capsules are packed in a bottle with a child-resistant cap. Each bottle contains 30 capsules.

Marketing Authorization Holder

Gilead Sciences Ireland UC

Carrigtohill

County Cork, T45 DP77

Ireland

Manufacturer

Gilead Sciences Ireland UC

IDA Business and Technology Park

Carrigtohill

Co. Cork

Ireland

Further information about this medicine is available by contacting the local representative of the Marketing Authorization 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: https://www.ema.europa.eu.