Lomitapide is used in adults 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).

Lomitapide also 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.

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

Lomitapide is available only from a certified pharmacy under a special program. You must be registered in the program and understand the risks and benefits of lomitapide.

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

You should not use lomitapide if you have severe liver disease or a history of abnormal liver function tests.

Do not use if you are pregnant. Birth control pills may be less effective if you vomit or have diarrhea. Ask your doctor about the best way to prevent pregnancy while you are taking lomitapide.

Tell your doctor about all your current medicines and any you start or stop using. Many drugs can affect lomitapide, and some drugs should not be used at the same time.

Lomitapide can cause liver problems. Call your doctor at once if you have nausea, vomiting, upper stomach pain, tiredness, flu-like symptoms, dark urine, or jaundice (yellowing of the skin or eyes).

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 will perform blood tests to make sure lomitapide is safe for you to take.

Take lomitapide on an empty stomach, at least 2 hours after your evening meal.

Swallow the capsule whole and do not crush, chew, break, or dissolve it. Take this medicine with a full glass of water.

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.

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

Store at room temperature away from moisture and heat. Keep the bottle tightly closed when not in use.

Usual Adult Dose for Hyperlipidemia:

Initial dose: 5 mg orally once a day
Maintenance dose: 5 to 60 mg orally once a day (should be individualized, taking into account the goal of therapy and the response to treatment)
Maximum dose: 60 mg orally once a day

Comments:
-Dose should be escalated gradually based on response, safety, and tolerability. The dose may be escalated using the following incremental schedule: 5 mg orally once a day for a minimum of 2 weeks, then 10 mg, 20 mg, 40 mg, 60 mg orally once a day after a minimum of 4 weekly intervals between each dose increase.
-Lomitapide should be taken with a full glass of water on an empty stomach at least 2 hours after the evening meal.

Usual Adult Dose for Homozygous Familial Hypercholesterolemia:

Initial dose: 5 mg orally once a day
Maintenance dose: 5 to 60 mg orally once a day (should be individualized, taking into account the goal of therapy and the response to treatment)
Maximum dose: 60 mg orally once a day

Comments:
-Dose should be escalated gradually based on response, safety, and tolerability. The dose may be escalated using the following incremental schedule: 5 mg orally once a day for a minimum of 2 weeks, then 10 mg, 20 mg, 40 mg, 60 mg orally once a day after a minimum of 4 weekly intervals between each dose increase.
-Lomitapide should be taken with a full glass of water on an empty stomach at least 2 hours after the evening meal.

You should not use lomitapide if you are allergic to it, or if you:

• are pregnant;

• have moderate or severe liver disease, or active liver disease; or

• have abnormal liver function tests.

Some drugs should not be used with lomitapide. Your treatment plan may change 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.

May harm an unborn baby. Do not use if you are pregnant. Use effective birth control while using lomitapide. Tell your doctor if you become pregnant.

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

Birth control pills may be less effective if you vomit or have diarrhea. Ask your doctor about the best way to prevent pregnancy while taking lomitapide.

Ask a doctor if it is safe to breastfeed while using lomitapide.

Skip the missed dose and use your next dose at the regular time. Do not use two doses at one time. Talk to your doctor if you stop taking lomitapide for more than a week.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

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).

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

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.

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 cause side effects. Avoid consuming grapefruit products.

Do not drink more than 1 alcoholic drink per day. Drinking alcohol may increase your risk of liver damage.

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Stop taking lomitapide and tell your doctor if you have:

• severe diarrhea;

• a light-headed feeling, like you might pass out;

• decreased urination; or

• tiredness.

Call your doctor at once if you have signs of liver problems, such as:

• 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 of lomitapide 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.

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 hepatitis C or HIV;

• 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.

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.