Patient Medication Information: uses, side effects, how to take - Lyvdelzi
What is LYVDELZI used for?
For the following indication LYVDELZI has been approved with conditions (NOC/c). This means it has passed Health Canada’s review and can be bought and sold in Canada, but the manufacturer has agreed to complete more studies to make sure the drug works the way it should. For more information, talk to your healthcare professional.
- LYVDELZI is used in adults to treat primary biliary cholangitis (PBC), a liver disease. It is used along with another medicine, ursodeoxycholic acid (UDCA), in patients who have not responded well to UDCA. Or, it is used by itself in patients who are not able to tolerate UDCA.
What is a Notice of Compliance with Conditions (NOC/c)?
A Notice of Compliance with Conditions (NOC/c) is a type of approval to sell a drug in Canada.
Health Canada only gives an NOC/c to a drug that treats, prevents, or helps identify a serious or life-threatening illness. The drug must show promising proof that it works well, is of high quality, and is reasonably safe. Also, the drug must either respond to a serious medical need in Canada, or be much safer than existing treatments.
Drug makers must agree in writing to clearly state on the label that the drug was given an NOC/c, to complete more testing to make sure the drug works the way it should, to actively monitor the drug’s performance after it has been sold, and to report their findings to Health Canada.
How LYVDELZI works:
LYVDELZI works by decreasing the amount of bile acid made in the liver which reduces liver inflammation and scarring. LYVDELZI may also reduce itch due to PBC.
The ingredients in LYVDELZI are:
Medicinal ingredients: seladelpar (as seladelpar lysine)
Non-medicinal ingredients: Black iron oxide, Butylated hydroxytoluene, Colloidal silicon dioxide, Croscarmellose sodium, FD&C Blue #2, Gelatin, Magnesium stearate, Mannitol, Microcrystalline cellulose, Potassium Hydroxide, Povidone, Propylene Glycol, Red iron oxide, Shellac, Sodium Hydroxide, Titanium dioxide, Yellow iron oxide
LYVDELZI seladelpar capsules
LYVDELZI comes in the following dosage forms:
Capsules; 10 mg seladelpar (as seladelpar lysine).
Do not use LYVDELZI if:
- You are allergic to seladelpar.
- You are allergic to any of the other ingredients in LYVDELZI or to any part of the container.
LYVDELZI is not approved for use in patients 17 years of age and younger. It is not known if LYVDELZI is safe and effective in these patients.
To help avoid side effects and ensure proper use, talk to your healthcare professional before you take LYVDELZI. Talk about any health conditions or problems you may have, including if you:
- Have kidney problems and are on dialysis.
- Have an advanced liver disease known as decompensated cirrhosis.
- Have a blockage of the bile ducts in your liver called a biliary obstruction.
- Have received a liver transplant.
- Are taking the medicine probenecid, used to treat gout. Taking LYVDELZI along with probenecid is not recommended.
Other warnings you should know about:
Liver Problems
LYVDELZI may affect your liver test results. Your healthcare professional will monitor your liver function before you start taking LYVDELZI and while you are taking it. Talk to your healthcare professional if you get any of the following symptoms of liver problems: yellowing of the skin or eyes, dark urine, nausea, vomiting, weight loss, abdominal pain, fatigue and itching. Your healthcare professional may interrupt or stop your treatment with LYVDELZI entirely.
Pregnancy
Talk to your healthcare professional before you take LYVDELZI if you are pregnant, think you might be pregnant or are planning to become pregnant. It is not known if LYVDELZI will harm your unborn baby. If you get pregnant while taking LYVDELZI, tell your healthcare professional.
Breastfeeding
Talk to your healthcare professional before you take LYVDELZI if you are breastfeeding or plan to breastfeed. It is not known if LYVDELZI passes into your breast milk. Talk to your healthcare professional about the best way to feed your baby if you take LYVDELZI.
Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, natural supplements or alternative medicines.
The following may interact with LYVDELZI:
- Probenecid, used to treat gout.
LYVDELZI seladelpar capsules
- Cyclosporine, 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.
- Carbamazepine, used to treat seizures and mood disorders.
- Rifampin, used to treat bacterial infections.
- Sulfaphenazole*, used to treat bacterial infections.
* Not available in Canada
How to take LYVDELZI:
- Always take LYVDELZI exactly as your healthcare professional has told you. Check with your healthcare professional if you are not sure.
You can take LYVDELZI with or without food.
- Swallow capsules whole with water.
- If you also take a medicine called a bile acid sequestrant, take LYVDELZI at least 4 hours before or 4 hours after taking the bile acid sequestrant. If this is not possible, space the time between taking LYVDELZI and your bile acid sequestrant as far apart as possible.
Usual dose:
The usual adult dose is one 10 mg capsule taken once a day.
Overdose:
If you think you, or a person you are caring for, have taken too much LYVDELZI, contact a healthcare professional, hospital emergency department, or regional poison control centre or Health Canada’s toll-free number, 1-844 POISON-X (1-844-764-7669) immediately, even if there are no symptoms.
Missed Dose:
If you forget to take a dose, skip the missed dose. Take your next dose at its scheduled time. Never take a double dose to make up for a missed dose.
Possible side effects from using LYVDELZI:
These are not all the possible side effects you may have when taking LYVDELZI. If you experience any side effects not listed here, tell your healthcare professional. Side effects may include:
- Headache
- Stomach pain
- Feeling sick (nausea)
- Stomach swelling
- Dizziness
- Rash
Serious side effects and what to do about them
| Side Effect/Symptom | Talk to your healthcare professional | Stop taking this drug and get immediate medical help | ||
|---|---|---|---|---|
| Only if severe | In all cases | |||
LYVDELZI seladelpar capsules
| Common | |||
|---|---|---|---|
| Fracture (a break or crack in a bone) | X | ||
| Liver problems: yellowing of the skin or eyes, dark urine, nausea, vomiting, weight loss, abdominal pain, fatigue and itching | X | ||
| Uncommon | |||
| Anemia (decreased number of red blood cells): fatigue, loss of energy or weakness, looking pale, shortness of breath | X | ||
If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, tell your healthcare professional.
Reporting Side Effects
You can report any suspected side effects associated with the use of health products to Health Canada by:
- Visiting the Web page on Adverse Reaction Reporting (canada.ca/drug-device-reporting) for information on how to report online, by mail or by fax; or
- Calling toll-free at 1-866-234-2345.
NOTE: Contact your health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.
Storage:
Store LYVDELZI at 15 to 25 °C.
Keep LYVDELZI in its original container and keep the bottle tightly closed. Do not use if the seal on the bottle is broken or missing.
Keep out of reach and sight of children.
If you want more information about LYVDELZI:
- Talk to your healthcare professional
- Find the full product monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada website: (https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html); the manufacturer’s website [www.gilead.ca], or by calling 1-866-207-4267.
Last Revised: 2025-10-16
LYVDELZI seladelpar capsules
Gilead Sciences, Inc. Foster City, CA 94404 USA
Gilead Sciences Canada, Inc. Mississauga, ON L5N 7K2
LYVDELZI® is a trademark of Gilead Sciences, Inc. or its related companies. All other marks referenced herein are the property of their respective owners.
© 2025 Gilead Sciences, Inc. All rights reserved.
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