lomitapide

What is the most important information I should know about lomitapide?

Tell your doctor about all your current medicines and any you start or stop using. Many drugs can interact with lomitapide, and some drugs should not be used together.

What is lomitapide?

Lomitapide reduces blood levels of "bad" cholesterol, such as low-density lipoprotein (LDL) or non-high-density liproprotein (non-HDL), as well as a protein that carries bad cholesterol in the blood.

Lomitapide is used together with a low-fat diet and other treatments to lower total cholesterol in people with homozygous familial hypercholesterolemia (an inherited type of high cholesterol).

It is not known whether lomitapide will lower your risk of heart disease.

Lomitapide is available only under a special program. You must be registered in the program and understand the risks and benefits of this medicine.

Lomitapide may also be used for purposes not listed in this medication guide.

What should I discuss with my healthcare provider before taking lomitapide?

• you have severe liver disease;
• you have abnormal liver function tests; or
• you are pregnant.

Many drugs can interact and cause dangerous effects. Some drugs should not be used together with lomitapide. Your doctor may change your treatment plan if you also use:

• aprepitant;
• conivaptan;
• crizotinib, imatinib;
• nefazodone;
• an antibiotic --ciprofloxacin, clarithromycin, erythromycin, telithromycin;
• antifungal medication --fluconazole, itraconazole, ketoconazole, posaconazole, voriconazole;
• heart or blood pressure medicine --diltiazem, verapamil;
• hepatitis C medication --boceprevir or telaprevir; or
• HIV or AIDS medicine --atazanavir, darunavir when given with ritonavir, fosamprenavir, indinavir, lopinavir, nelfinavir, ritonavir, saquinavir, tipranavir.

Tell your doctor if you have ever had:

• liver problems, even if caused by taking certain medicines;
• kidney disease (or if you are on dialysis);
• bowel problems, or an intestinal disorder;
• hereditary galactose intolerance, severe lactase deficiency, or glucose galactose malabsorption; or
• if you drink large amounts of alcohol.

You may need to have a negative pregnancy test before starting this treatment.

If you become pregnant, your name may be listed on a pregnancy registry to track the effects of lomitapide on the baby.

How should I take lomitapide?

Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose. Use the medicine exactly as directed.

Your doctor may have you take vitamin E or essential fatty acid supplements while you are taking lomitapide. Take only the type and amount of vitamins or supplements your doctor has prescribed.

You will need frequent medical tests.

Lomitapide is only part of a treatment program that may also include exercise and weight control. Follow your doctor's instructions very closely.

What happens if I miss a dose?

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

What happens if I overdose?

What should I avoid while taking lomitapide?

Avoid eating foods high in fat or cholesterol, or lomitapide will not be as effective and may cause nausea, vomiting, and stomach pain.

Grapefruit may interact with lomitapide and lead to unwanted side effects. Avoid the use of grapefruit products.

What are the possible side effects of lomitapide?

• nausea, vomiting, upper stomach pain;
• loss of appetite;
• swelling around your midsection;
• flu-like symptoms, tiredness;
• dark urine, clay-colored stools; or
• jaundice (yellowing of the skin or eyes).

Common side effects may include:

• stomach cramps;
• nausea, vomiting;
• indigestion; or
• diarrhea.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect lomitapide?

Some medicines can make lomitapide much less effective when taken at the same time. If you take cholestyramine or colesevelam, take your lomitapide dose 4 hours before or 4 hours after you take the other medicine.

Tell your doctor about all your current medicines. Many drugs can affect lomitapide, especially:

• acetaminophen, isotretinoin, methotrexate, or tamoxifen;
• an antidepressant;
• antiviral medicine to treat HIV or hepatitis C;
• heart or blood pressure medicine;
• birth control pills;
• an antibiotic --demeclocycline, doxycycline, minocycline, eravacycline, omadacycline, sarecycline, tetracycline;
• a blood thinner --warfarin, Coumadin, Jantoven; or
• cholesterol medication --atorvastatin or simvastatin.

This list is not complete and many other drugs may affect lomitapide. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.

Where can I get more information?

Your pharmacist can provide more information about lomitapide.