Lyvdelzi
Italy
Table of Contents
Patient Information Leaflet
Lyvdelzi 10 mg hard capsules
seladelpar
This medicinal product is subject to additional monitoring. This will allow for the rapid identification of new safety information. You can help by reporting any side effects you experience while taking this medicine. See the end of section 4 for information on how to report side effects.
Please read this leaflet carefully before taking this medicine, as it contains important information for you.
- Keep this leaflet. 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 give it to other people, even if their symptoms are the same as yours, as it may be harmful.
- If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist, or nurse. See section 4.
Contents of this leaflet
- What Lyvdelzi is and what it is used for
- What you need to know before taking Lyvdelzi
- How to take Lyvdelzi
- Possible side effects
- How to store Lyvdelzi
- 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 called
"peroxisome proliferator-activated receptor delta agonists".
This medicine is used in adults to treat primary biliary cholangitis (PBC), a type of liver disease
characterised by the progressive destruction of the bile ducts, which hinders the flow of bile. Bile is a
fluid that helps digest food, especially fats. If bile cannot reach the digestive tract, it accumulates in the
liver ("cholestasis"), damaging liver tissue. This can reduce liver function and cause inflammation.
Lyvdelzi can be used together with ursodeoxycholic acid (UDCA) or alone in patients who cannot use
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). By doing so, it reduces the
production and accumulation of bile in the liver, as well as liver inflammation.
2. What you need to know before taking Lyvdelzi
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
Before starting Lyvdelzi and during treatment, your doctor may carry out blood tests to monitor liver function. If these tests show worsening liver function, your doctor may need to stop treatment temporarily. Treatment may be restarted later if liver function improves. However, if liver function worsens again after restarting treatment, your doctor may permanently discontinue treatment with Lyvdelzi. Contact your doctor immediately if, during treatment, you develop symptoms of liver dysfunction (liver inflammation) or complete biliary obstruction (blocked bile duct), including:
- stomach ache (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
Tell your doctor, pharmacist, or nurse if you are taking, have recently taken, or might take any other medicines or herbal remedies.
In particular, inform your doctor, pharmacist, or nurse if you are taking medicines known as:
- probenecid, used to treat gout
- ciclosporin, used to prevent organ rejection after transplantation
- “bile acid binding resins” (such as cholestyramine, colestipol, or colesevelam), used to lower blood cholesterol levels. These may reduce the effectiveness of Lyvdelzi if taken too close to the time of Lyvdelzi intake
- if you are taking a “bile acid binding resin”, you must take Lyvdelzi at least 4 hours before or 4 hours after taking the “bile acid binding resin”. See section 3 for more information.
The following medicines may increase the amount of Lyvdelzi in your blood and therefore the risk of side effects with Lyvdelzi:
- fluconazole, used to treat fungal infections
- mifepristone, a medicine used for medical termination of pregnancy
Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
Driving and using machines
It is unlikely that this medicine will affect your ability to drive, ride a bicycle, or operate tools or machinery.
Lyvdelzi contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per hard capsule, i.e. it is essentially “sodium-free”.
3. How to take Lyvdelzi
Take this medicine exactly as your doctor, pharmacist, or nurse has told you. If you are unsure, consult your doctor, pharmacist, or nurse.
How much medicine to take
The recommended dose is one 10 mg capsule taken once daily.
How to take the medicine
- Swallow the capsule whole with water.
- This medicine can be taken with or without food.
- Lyvdelzi is taken together with another medicine called “ursodeoxycholic acid” (UDCA, also known as ursodiol), or alone if you cannot take UDCA. If you are already taking a bile acid-binding resin:
- Take Lyvdelzi at least 4 hours before or at least 4 hours after taking the bile acid-binding resin.
- If in doubt, consult 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-coloured urine or muscle pain.
If you forget to take Lyvdelzi
If you forget to take Lyvdelzi, do not take the missed dose. Take the next dose at the usual scheduled time.
Do not take a double dose to make up for a missed dose.
If you stop taking Lyvdelzi
Do not stop taking this medicine without first talking to your doctor, pharmacist, or nurse.
If you have any doubts about how to use this medicine, consult 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.
Very common: may affect more than 1 in 10 people
- stomach ache (abdominal pain)
Common: may affect up to 1 in 10 people
- headache
- feeling unwell (nausea)
- abdominal swelling (abdominal distension)
Reporting of side effects
If you get any side effects, including those not listed in this leaflet, talk to your doctor, pharmacist or nurse. You can also report side effects directly through the national reporting system detailed in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.
5. How to store Lyvdelzi
Keep this medicine out of the 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 that month.
Do not store this medicine above 30 °C.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.
6. Package contents and other information
What Lyvdelzi contains
- The active substance is seladelpar.
- Each Lyvdelzi hard capsule contains 10 mg of seladelpar.
- The other components are:
- capsule contents – microcrystalline cellulose, mannitol, croscarmellose sodium, butylated hydroxytoluene, magnesium stearate, colloidal silicon dioxide
- capsule shell – gelatin, titanium dioxide, black iron oxide (E172), red iron oxide (E172), yellow iron oxide (E172), indigotine (E132)
- black ink used to print “10” on the body of the capsule shell – shellac (E904), propylene glycol (E1520), potassium hydroxide (E525), black iron oxide (E172)
- white ink used to print “CBAY” on the cap of the capsule – 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.
Description of Lyvdelzi and package contents
This medicine is a hard capsule with a dark blue opaque cap and a light grey opaque body, with “CBAY” printed in white ink on the cap and “10” printed in black ink on the body. The capsules are packed in a bottle with a child-resistant cap.
Each bottle contains 30 capsules. Single packs contain 1 bottle with 30 capsules, and packs of 3 bottles contain a total of 90 capsules (3 bottles, each containing 30 capsules).
Not all pack sizes may be marketed.
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
For further information about this medicine, please contact the local representative of the Marketing Authorization Holder:
België/Belgique/Belgien Lietuva
Gilead Sciences Belgium SRL-BV Gilead Sciences Ireland UC
Tél/Tel: + 32 (0) 24 01 35 50 Tel: + 353 (0) 1 686 1888
България Luxembourg/Luxemburg
Gilead Sciences Ireland UC Gilead Sciences Belgium SRL-BV
Тел.: + 353 (0) 1 686 1888 Tél/Tel: + 32 (0) 24 01 35 50
Česká republika Magyarország
Gilead Sciences s.r.o. Gilead Sciences Ireland UC
Tel: + 420 910 871 986 Tel.: + 353 (0) 1 686 1888
Danmark Malta
Gilead Sciences Sweden AB Gilead Sciences Ireland UC
Tlf.: + 46 (0) 8 5057 1849 Tel: + 353 (0) 1 686 1888
Deutschland Nederland
Gilead Sciences GmbH Gilead Sciences Netherlands B.V.
Tel: + 49 (0) 89 899890-0 Tel: + 31 (0) 20 718 36 98
Eesti Norge
Gilead Sciences Ireland UC Gilead Sciences Sweden AB
Tel: + 353 (0) 1 686 1888 Tlf: + 46 (0) 8 5057 1849
Ελλάδα Österreich
Gilead Sciences Ελλάς Μ.ΕΠΕ. Gilead Sciences GesmbH
Τηλ: + 30 210 8930 100 Tel: + 43 1 260 830
España Polska
Gilead Sciences, S.L. Gilead Sciences Poland Sp. z o.o.
Tel: + 34 91 378 98 30 Tel.: + 48 22 262 8702
France Portugal
Gilead Sciences Gilead Sciences, Lda.
Tél: + 33 (0) 1 46 09 41 00 Tel: + 351 21 7928790
Hrvatska România
Gilead Sciences Ireland UC Gilead Sciences (GSR) S.R.L.
Tel: + 353 (0) 1 686 1888 Tel: + 40 31 631 18 00
Ireland Slovenija
Gilead Sciences Ireland UC Gilead Sciences Ireland UC
Tel: + 353 (0) 214 825 999 Tel: + 353 (0) 1 686 1888
Ísland Slovenská republika
Gilead Sciences Sweden AB Gilead Sciences Slovakia s.r.o.
Sími: + 46 (0) 8 5057 1849 Tel: + 421 232 121 210
Italia Suomi/Finland
Gilead Sciences S.r.l. Gilead Sciences Sweden AB
Tel: + 39 02 439201 Puh/Tel: + 46 (0) 8 5057 1849
Κύπρος Sverige
Gilead Sciences Ελλάς Μ.ΕΠΕ. Gilead Sciences Sweden AB
Τηλ: + 30 210 8930 100 Tel: + 46 (0) 8 5057 1849
Latvija
Gilead Sciences Ireland UC
Tel: + 353 (0) 1 686 1888
This medicine has been granted a conditional marketing authorization. This means that additional data on this medicine are required.
The European Medicines Agency will review new information on this medicine at least annually, and the product information (SmPC) will be updated as necessary.
Further sources of information
More detailed information on this medicine is available on the European Medicines Agency website, https://www.ema.europa.eu.