Lomitapide

Lomitapide may cause serious damage to the liver. Tell your doctor if you have or have ever had liver disease or if you have ever had liver problems while taking other medications. Your doctor may tell you not to take lomitapide. Tell your doctor if you drink alcohol. Drinking alcohol may increase the risk that you will develop liver problems. Do not drink more than one alcoholic beverage per day while you are taking lomitapide. Using some medications with lomitapide may increase the risk of liver damage. Tell your doctor and pharmacist what prescription and nonprescription medications you are taking or plan to take while taking lomitapide. If you experience any of the following symptoms, stop taking lomitapide and call your doctor immediately: extreme tiredness, lack of energy, weakness, nausea or vomiting that gets worse or does not go away, pain in the upper right part of the stomach, loss of appetite, yellowing of the skin or eyes, fever, or flu-like symptoms. Your doctor may need to change the dose or stop or delay your treatment if you experience liver problems.

Lomitapide is available only through a special restricted distribution program. A Juxtapid REMS ^® program (Risk Evaluation and Mitigation Strategies) has been set up because of the risk of liver damage. You will only be able to receive lomitapide if you, your doctor, and your pharmacy are enrolled in this program

Keep all appointments with your doctor and the laboratory. Your doctor will order certain tests before and during your treatment to check your body's response to lomitapide.

You will be given the Medication Guide. Read the information carefully and ask your doctor or pharmacist if you have any questions.

Uses
How to Use
Precautions
Side Effects
Storage/Disposal
More Information

Why is this medicine prescribed?

Lomitapide is used to lower cholesterol (a fat-like substance that can build up and clog blood vessels causing heart attacks or strokes or other health problems) in people that have homozygous familial hypercholesterolemia (HoFH; an inherited condition in which cholesterol cannot be removed from the body normally). Lomitapide is in a class of medications called cholesterol-lowering medications. It works by slowing the production of cholesterol in the body to decrease the amount of cholesterol that may build up on the walls of the arteries and block blood flow to the heart, brain, and other parts of the body.

Are there other uses for this medicine?

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

How should this medicine be used?

Lomitapide comes as a capsule to take by mouth. Take once a day on an empty stomach, at least 2 hours after your evening meal. Take lomitapide around the same time each day.

Take lomitapide exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Swallow the capsules whole with a glass of water; do not split, chew, dissolve, or crush them. If you cannot swallow the capsules whole, open the capsules and sprinkle the contents over 1 tablespoon of applesauce or mashed banana. Swallow the mixture immediately.

You will need to take a vitamin supplement during your treatment with lomitapide Be sure to follow the recommendations made by your doctor carefully.

Continue to take lomitapide even if you feel well. Do not stop taking lomitapide without talking to your doctor.

What special precautions should I follow?

Before taking lomitapide,

tell your doctor or pharmacist if you are allergic to this medication, any part of this medication, or any other medications, foods or substances. Tell your doctor or pharmacist about the allergy and what symptoms you had.
some medications should not be taken with lomitapide. Other medications may cause dosing changes or extra monitoring when taken with lomitapide. Make sure you have discussed any medications you are currently taking or plan to take before starting lomitapide with your doctor and pharmacist. Before starting, stopping, or changing any medications while taking lomitapide, please get the advice of your doctor or pharmacist.
the following nonprescription or herbal products may interact with lomitapide: acetaminophen. Be sure to let your doctor and pharmacist know that you are taking this medication before you start taking lomitapide. Do not start any of this medication while taking lomitapide without discussing with your healthcare provider
if you are taking cholestyramine, colesevelam, or colestipol, take it 4 hours before or 4 hours after lomitapide.
tell your doctor if you have or have ever had galactose intolerance or glucose-galactose malabsorption (inherited conditions where the body is not able to tolerate lactose), ongoing stomach or intestinal problems, or pancreas or kidney disease.
tell your doctor if you are pregnant or plan to become pregnant. If you can become pregnant, you will need to take a pregnancy test before you begin taking lomitapide. If you can become pregnant, you should use effective birth control while taking lomitapide. Talk to your doctor about birth control methods that will work for you. If you become pregnant while taking lomitapide, stop taking the medication and call your doctor immediately. Lomitapide can harm the fetus.
tell your doctor if you are breast-feeding. You should not breast-feed while you are taking lomitapide.

What special dietary instructions should I follow?

Do not eat grapefruit or drink grapefruit juice while taking this medication.

Eat a low-fat, low-cholesterol diet. Eating a low-fat diet may lower the chance that you will have stomach problems including nausea, vomiting, upset stomach, and diarrhea while you are taking lomitapide. Follow all exercise and dietary recommendations made by your doctor or dietitian carefully.

What should I do if I forget to take a dose?

Skip the missed dose and continue your regular dosing schedule the next day. Do not take a double dose to make up for a missed one.

What should I do in case of overdose?

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help . If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

What side effects can this medicine cause?

Lomitapide may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

diarrhea
nausea
vomiting
stomach pain
constipation
bloating
gas
upset stomach
weight loss
headache
dizziness
sore throat
runny nose
back pain

Some side effects can be serious. If you experience any of these symptoms or those listed in the IMPORTANT WARNING section, stop taking lomitapide and call your doctor immediately or get emergency medical treatment:

severe diarrhea
lightheadedness
decreased urine output
unexplained muscle pain, tenderness, or weakness; fever; or unusual tiredness

Lomitapide may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online ( https://www.fda.gov/Safety/MedWatch ) or by phone ( 1-800-332-1088).

What should I know about storage and disposal of this medication?

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom).

Keep all medication out of sight and reach of children as many containers are not child-resistant. Always lock safety caps. Place the medication in a safe location – one that is up and away and out of their sight and reach. https://www.upandaway.org Dispose of unneeded medications in a way so that pets, children, and other people cannot take them. Do not flush this medication down the toilet. Use a medicine take-back program. Talk to your pharmacist about take-back programs in your community. Visit the FDA's Safe Disposal of Medicines website https://goo.gl/c4Rm4p for more information.

What other information should I know?

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

Keep a written list of all of the prescription and nonprescription (over-the-counter) medicines, vitamins, minerals, and dietary supplements you are taking. Bring this list with you each time you visit a doctor or if you are admitted to the hospital. You should carry the list with you in case of emergencies.

This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.

The American Society of Health-System Pharmacists, Inc. represents that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. makes no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. does not endorse or recommend the use of any drug. The information is not a substitute for medical care.

AHFS ^® Patient Medication Information™. © Copyright, 2026. The American Society of Health-System Pharmacists ^® , 4500 East-West Highway, Suite 900, Bethesda, Maryland. All Rights Reserved. Duplication for commercial use must be authorized by ASHP.

Selected Revisions: May 15, 2026.