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. Tell your doctor and pharmacist if you are taking acetaminophen (Tylenol, others), amiodarone (Cordarone), doxycycline (Doryx, Vibramycin, others), isotretinoin (Accutane), methotrexate (Rheumatrex), minocycline (Dynacin, Minocin), tamoxifen (Nolvadex), or tetracycline (Sumycin). If you experience any of the following symptoms at any time during your treatment, 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.
A program called Juxtapid REMS® has been approved by the Food and Drug Administration (FDA) because of the possibility of liver damage associated with lomitapide use. All people who are prescribed lomitapide must have a lomitapide prescription from a doctor who is registered with Juxtapid REMS®, and have the prescription filled at a pharmacy that is registered with Juxtapid REMS® in order to receive this medication.
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.
Your doctor or pharmacist will give you the manufacturer's patient information sheet (Medication Guide) when you begin treatment with lomitapide and each time you refill your prescription. Read the information carefully and ask your doctor or pharmacist if you have any questions. You can also visit the Food and Drug Administration (FDA) website (http://www.fda.gov/Drugs/DrugSafety/ucm085729.htm) or the manufacturer's website to obtain the Medication Guide.
Lomitapide is used along with diet changes (restriction of cholesterol and fat intake) and other treatments to reduce the amount low-density lipoprotein (LDL) cholesterol ('bad cholesterol'), total cholesterol, and other fatty substances in the blood 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.
Accumulation of cholesterol and fats along the walls of your arteries (a process known as atherosclerosis) decreases blood flow and, therefore, the oxygen supply to your heart, brain, and other parts of your body. Lowering your blood level of cholesterol and fats may help prevent heart disease, angina (chest pain), strokes, and heart attacks.
Lomitapide comes as a capsule to take by mouth. It is usually taken once a day. Lomitapide should be taken without food on an empty stomach, at least 2 hours after your evening meal. Drink a full glass of water with each dose of lomitapide.
Take lomitapide at around the same time every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. 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; do not split, chew, dissolve, or crush them.
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.
This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.
Do not eat grapefruit or drink grapefruit juice while taking this medication.
Your doctor will tell you to eat a low-fat 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 dietary recommendations made by your doctor or dietitian carefully.
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.
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 [at http://www.fda.gov/Safety/MedWatch] or by phone [1-800-332-1088].
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). Throw away any medication that is outdated or no longer needed. Talk to your pharmacist about the proper disposal of your medication.
In case of overdose, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.
Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.
It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.
Last Revised - 02/15/2014
AHFS® Consumer Medication Information. © Copyright, 2015. The American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland. All Rights Reserved. Duplication for commercial use must be authorized by ASHP.