Patient Medication Information: uses, side effects, how to take - Nilemdo
What NILEMDO is used for:
NILEMDO is used in adults with hyperlipidemia (high blood cholesterol levels). In these patients, NILEMDO is used along with the following therapies to help lower blood cholesterol levels:
- statins, ezetimibe and/or PCSK9 inhibitors (other types of medicine used to lower blood cholesterol); or
- alone, or in combination with ezetimibe and/or PCSK9 inhibitors, when appropriate, in patients who are either intolerant to or should not be taking statins.
NILEMDO is also used with statins, as tolerated, or with ezetimibe and/or PCSK9 inhibitors, when appropriate, in adults presenting with a high risk of heart attack or stroke, to reduce the risk of:
- heart attack;
- stroke;
- death due to a heart attack or stroke; and
- undergoing a procedure called coronary artery revascularisation. This is a medical procedure used to treat severely blocked arteries due to plaque buildup caused by high blood cholesterol levels.
How NILEMDO works:
NILEMDO belongs to a class of medicines known as “lipid metabolism regulators”. It contains the medicinal ingredient bempedoic acid, which is inactive until it enters the liver where it is changed to its active form. NILEMDO decreases the production of cholesterol (a type of fat) in the liver and increases the removal of LDL (bad) cholesterol from the blood by blocking an enzyme needed for the production of cholesterol. This helps to reduce the risk of heart attack and stroke.
The ingredients in NILEMDO are:
Medicinal ingredient: bempedoic acid
Non-medicinal ingredients: colloidal silicon dioxide, hydroxypropyl cellulose, lactose monohydrate , magnesium stearate, microcrystalline cellulose, partially hydrolyzed polyvinyl alcohol, polyethylene glycol, sodium starch glycolate, talc and titanium dioxide.
NILEMDO comes in the following dosage form:
Tablets: 180 mg.
Do not use NILEMDO if:
- You are allergic to bempedoic acid or any of the other ingredients in NILEMDO.
- You are pregnant or think you might be pregnant.
- You are breastfeeding.
- You take more than 40 mg of simvastatin per day (another medicine used to lower cholesterol).
To help avoid side effects and ensure proper use, talk to your healthcare professional before you take NILEMDO. Talk about any health conditions or problems you may have, including if you:
- Ever had or are prone to have gout.
- Have severe kidney problems.
- Have severe liver problems.
- Are currently taking other medicines.
- Are able to get pregnant and are not using an effective birth control method, or are planning on becoming pregnant
Other warnings you should know about:
Hyperuricemia (high uric acid levels in the blood): NILEMDO may cause or worsen pre-existing hyperuricemia. This may lead to gout.
Muscle disorders: When taken together with a statin (another medicine used to treat high blood cholesterol), NILEMDO may cause serious muscle disorders. These may be accompanied with kidney problems and can lead to death. Tell your healthcare professional right away if you have any severe muscle pain, tenderness, soreness or weakness while taking NILEMDO.
Contraception (for female patients):
If you are female and able to become pregnant:
- your healthcare professional will ask you to take a pregnancy test to confirm that you are not pregnant before you start your treatment with NILEMDO;
- you should use an effective birth control method (contraception) during your treatment with NILEMDO.
If you plan on becoming pregnant, tell your healthcare professional. Your treatment with NILEMDO should be stopped first before you stop taking or using birth control.
Pregnancy:
- Do not take NILEMDO during pregnancy. It could harm your unborn baby. Your healthcare professional will discuss the potential risks with you.
- If you discover that you are pregnant while taking NILEMDO, stop taking the medicine and tell your healthcare professional right away.
- Pregnancy safety study: Information is being collected on patients who have been exposed to NILEMDO during pregnancy to track the effects of NILEMDO exposure on pregnant women and their offspring. Talk to your healthcare professional for more information.
Breastfeeding: It is not known if NILEMDO can pass into breast milk and harm a breastfed baby. Therefore, do not breastfeed while taking NILEMDO. Talk to your healthcare professional about the best way to feed your baby while you are taking NILEMDO.
Check-ups and testing: Your healthcare professional will do blood tests before and/or regularly during your treatment with NILEMDO. These tests will monitor the health of your liver and muscles and the levels of uric acid in your blood.
Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.
Serious drug interactions
Serious drug interactions with NILEMDO include:
- Doses greater than 40 mg of simvastatin.
The following may also interact with NILEMDO:
- Medicines used to treat high blood cholesterol known as statins (e.g., atorvastatin, fluvastatin, pravastatin, rosuvastatin, simvastatin).
- Bosentan, used to treat high blood pressure in the lungs.
- Glecaprevir and voxilaprevir, used to treat hepatitis C infection.
How to take NILEMDO:
- Always take NILEMDO exactly as your healthcare professional has told you. Check with your healthcare professional if you are not sure.
Swallow the tablet whole, with or without food.
Usual dose:
The usual adult dose is 1 tablet (180 mg) per day.
Overdose:
If you think you, or a person you are caring for, have taken too much NILEMDO, contact a healthcare professional, hospital emergency department, 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 signs or symptoms.
Missed dose:
If you miss a dose, take it later in the day, and take your next scheduled dose at your usual time the next day. Do not take two doses on the same day to make up for a missed dose.
Possible side effects from using NILEMDO:
These are not all the possible side effects you may have when taking NILEMDO. If you experience any side effects not listed here, tell your healthcare professional.
Side effects with NILEMDO may include:
- weight loss
Serious side effects and what to do about them
| Frequency/Side Effect/Symptom | Talk to your healthcare professional | Stop taking this drug and get immediate medical help | |
|---|---|---|---|
| Only if severe | In all cases | ||
| Common | |||
| Hyperuricemia (increased levels of uric acid in the blood): possible red, swollen, hot and painful joint (signs of gout). | X | ||
| Unknown | |||
| Anemia (decreased number of red blood cells): fatigue, loss of energy, looking pale, shortness of breath, weakness. | X | ||
| Allergic reactions: difficulty swallowing or breathing, wheezing, drop in blood pressure, feeling sick to your stomach and throwing up, hives or rash, swelling of the face, lips, tongue or throat. | 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 healthcare professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.
Storage:
- Store at room temperature (15°C to 30°C).
- Do not use this medicine after the expiry date stated on the packaging.
- Keep out of reach and sight of children.
If you want more information about NILEMDO:
- Talk to your healthcare professional
- Find the full product monograph that is prepared for healthcare professionals and includes the Patient Medication Information by visiting the Health Canada Drug Product Database website (https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html); the manufacturer’s website www.Nilemdo.ca; or by calling 1-833-266-3423.
Date of Authorization: 2025-11-14