Lomitapide

Lomitapide is used to lower LDL-C levels in adults and children aged 2 years and older who have homozygous familial hypercholesterolemia (HoFH), along with a low-fat diet, exercise, and other treatments for low-density lipoprotein cholesterol.

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

It is not known if lomitapide will reduce your risk of heart problems.

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

Lomitapide may also be used for reasons not mentioned in this medication guide.

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.

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 not work as well 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 that 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 immediately if you have nausea, vomiting, upper stomach pain, tiredness, flu-like symptoms, dark urine, or jaundice (yellowing of the skin or eyes).

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.

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.

Usual Child Dose of Juxtapid for Homozygous Familial Hypercholesterolemia

• The dose varies depending on age.
• See the Juxtapid Prescribing Information for full dosage information.

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

Skip the missed dose and take your next dose at the regular time. Do not take two doses at the same 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.

• 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.

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.