Patient leaflet - Livdelzi 10 mg capsules
1. What Livdelzi is and what it is used for
What Livdelzi is
Livdelzi contains the active substance seladelpar. This belongs to a group of medicines called peroxisome proliferator-activated receptor delta agonists.
What Livdelzi is used for
This medicine is used to treat adults who have a liver illness called ‘primary biliary cholangitis’ (PBC). Livdelzi can also reduce itching that is linked to PBC.
How Livdelzi works
This medicine works by controlling liver problems in the body and making the liver less inflamed.
Livdelzi can be taken with another medicine
Livdelzi can be taken:
- together with another medicine called ‘ursodeoxycholic acid’ (called UDCA or ‘urso’ or ‘ursodiol’)
- or by itself – if you cannot take urso or ursodiol
2. What you need to know before you take Livdelzi
Do not take Livdelzi if:
- you are allergic to seladelpar or any of the other ingredients of this medicine (listed in section 6)
you have something called ‘complete biliary obstruction,’
- this is a blockage of your bile duct which prevents bile flow from the liver into your gut.
Do not take Livdelzi if any of the above apply to you. If you are not sure, talk to your doctor, pharmacist or nurse before taking this medicine.
Warnings and precautions
Your doctor may need to stop your Livdelzi treatment if your liver starts to not work as well. They may then start it again if your liver recovers.
Children and adolescents
Do not give this medicine to children and adolescents below 18 years of age.
Blood tests
Your doctor may do regular blood tests to check your liver health when you start Livdelzi and while you are taking it.
Other medicines and Livdelzi
Tell your doctor, pharmacist or nurse if you are taking, have recently taken, or might take any other medicines. This includes medicines obtained without a prescription and herbal medicines.
In particular, tell your doctor, pharmacist or nurse if you are taking any of the following medicines:
‘bile acid binding resins’ (such as cholestyramine, colestipol, or colesevelam adsorb) - used to lower blood cholesterol levels or itching caused by PBC. These may make Livdelzi work less well if taken too close to when you take Livdelzi.
If you are taking a ‘bile acid binding resin’, you will need to take Livdelzi at least 4 hours before or at least 4 hours after taking a ‘bile acid binding resin’. See section 3 for more information.
- Ciclosporin, used to prevent the body from rejecting a transplanted organ.
- Fluconazole, used to treat fungal infections.
- Mifepristone, used for the medical termination of a pregnancy.
- Probenecid, used to treat gout.
Pregnancy and breastfeeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Driving and using tools or machines
This medicine is not likely to affect you being able to drive, cycle or use any tools or machines.
3. How to take Livdelzi
Always take this medicine exactly as described in this leaflet or as your doctor, pharmacist or nurse has told you. Check with your doctor, pharmacist or nurse if you are not sure.
How much to take
The recommended dose of Livdelzi is 10 mg taken once daily.
How to take
You can take this medicine with or without food.
- Livdelzi is taken either together with another medicine called ‘ursodeoxyycholic acid’ (UDCA, also called urso or ursodiol) – or by itself if you cannot have urso or ursodiol.
If you are already taking a bile acid binding resin:
- Take Livdelzi at least 4 hours before – or at least 4 hours after – taking the bile acid binding resin.
- If you are unsure, ask your doctor, pharmacist or nurse.
If you take more Livdelzi than you should
If you take more Livdelzi than you should, tell your doctor, pharmacist or nurse straight away.
If you forget to take Livdelzi
Do not take a double dose to make up for a forgotten capsule.
If you stop taking Livdelzi
Do not stop taking this medicine without talking to your doctor, pharmacist or nurse.
If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Side effects
Tell your doctor, pharmacist or nurse if you notice any of the following side effects.
Common: may affect up to 1 in 10 people
- headache
- feeling sick (nausea)
- tummy pain or swelling
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at https://yellowcard.mhra.gov.uk/ or search MHRA Yellow Card in the Google Play or Apple App Store.
By reporting side effects, you help provide more information about the safety of taking this medicine.
5. How to store Livdelzi
- 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 bottle after “EXP”. The expiry date refers to the last day of that month.
- Store below 25°C.
- Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
6. Contents of the pack and other information
What Livdelzi contains
- The active substance is seladelpar.
- Each capsule of Livdelzi contains 10 mg of seladelpar.
The other ingredients are:
- capsule content – microcrystalline cellulose, mannitol, croscarmellose sodium, butyl hydroxytoluene, magnesium stearate, colloidal silicon dioxide ■ capsule shell – gelatine, titanium dioxide, black iron oxide (E172), red iron oxide (E172), yellow iron oxide (E172), indigo carmine (E132)
black ink used to imprint “10” on the body of the capsule shell – Shellac (E904), propylene glycol (E1520), potassium hydroxide (E525), black iron oxide (E172) ■ white ink used to imprint “CBAY” on the cap of the capsule – Shellac (E904), propylene glycol (E1520), sodium hydroxide (E524), povidone (E1201), titanium dioxide
What Livdelzi looks like and contents of the pack
This medicine is a capsule with a light grey body and a dark blue cap, printed with “CBAY” on the cap and “10” on the body. The capsules are packaged in a bottle with a child resistant cap with an outer carton. Each bottle contains 30 capsules.
Marketing Authorisation Holder
Gilead Sciences Ltd
280 High Holborn
London
WC1V 7EE
United Kingdom
Manufacturer
Gilead Sciences Ireland UC
IDA Business and Technology Park
Carrigtohill
Co. Cork
Ireland
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
Gilead Sciences Ltd
Tel: +44(0) 8000 113 700
This leaflet was last revised in 06/2025.
Livdelzi® 10 mg capsules
Seladelpar
Livdelzi®
10 mg capsules
Seladelpar