lomitapide

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Pronunciation: loe MI ta pide

Brand: Juxtapid

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

Do not use lomitapide if you are pregnant.

Some medicines can interact with lomitapide and should not be used at the same time. Tell your doctor about all medicines you use, and those you start or stop using during your treatment with lomitapide.

Stop using lomitapide and call your doctor at once if you have nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, or jaundice (yellowing of the skin or eyes).

What is lomitapide?

Lomitapide is a cholesterol-lowering medication. It 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 may also be used for purposes not listed in this medication guide.

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

Lomitapide is available only under a special program called the Juxtapid REMS Program. You must be registered in the program and understand the risks and benefits of taking this medication.

You should not use lomitapide if you are allergic to it, if you have severe liver disease, or if you are pregnant.

Some medicines can interact with lomitapide and should not be used at the same time. Your doctor may need to change your treatment plan if you use any of the following drugs:

  • aprepitant;
  • crizotinib, imatinib;
  • nefazodone;
  • an antibiotic--ciprofloxacin, clarithromycin, erythromycin, telithromycin;
  • antifungal medication--fluconazole, itraconazole, ketoconazole, posaconazole, voriconazole;
  • heart or blood pressure medicine--diltiazem, verapamil;
  • the hepatitis C medications boceprevir or telaprevir; or
  • HIV or AIDS medicine--atazanavir, cobicistat (Evotaz, Prezcobix, Stribild, Tybost), darunavir when given with ritonavir, delavirdine, fosamprenavir, indinavir, nelfinavir, ritonavir, saquinavir, tipranavir.

To make sure lomitapide is safe for you, tell your doctor if you have:

  • liver disease, hepatitis C, or abnormal liver function tests;
  • kidney disease (or if you are on dialysis);
  • HIV or AIDS;
  • bowel problems, or an intestinal disorder;
  • hereditary galactose intolerance, severe lactase deficiency, or glucose galactose malabsorption; or
  • if you drink large amounts of alcohol.

This medication can harm an unborn baby or cause birth defects. Do not use lomitapide if you are pregnant. You may need to have a negative pregnancy test before starting this treatment. Use effective birth control to prevent pregnancy while taking lomitapide. Tell your doctor right away if you become pregnant during treatment.

If you are pregnant, your name may be listed on a pregnancy registry. This is to track the outcome of the pregnancy and to evaluate any effects of lomitapide on the baby.

Lomitapide can make birth control pills less effective. Ask your doctor about using non hormonal birth control (condom, diaphragm with spermicide) to prevent pregnancy while taking lomitapide.

It is not known whether lomitapide passes into breast milk or if it could harm a nursing baby. You should not breast-feed while using this medicine.

How should I take lomitapide?

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

Lomitapide is usually taken once daily, at least 2 hours after your evening meal. Your doctor may occasionally change your dose to make sure you get the best results. Follow all directions on your prescription label. Do not take this medicine in larger or smaller amounts or for longer than recommended.

Take this medicine with a full glass of water.

Do not crush, chew, break, or open a lomitapide capsule. Swallow it whole.

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.

While using lomitapide, you may need frequent blood tests at your doctor's office.

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

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

What happens if I miss a dose?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

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

What should I avoid while taking lomitapide?

Grapefruit and grapefruit juice may interact with lomitapide and lead to unwanted side effects. Do not drink grapefruit juice while taking lomitapide.

Avoid eating foods that are high in fat or cholesterol. Lomitapide will not be as effective in lowering your cholesterol if you do not follow a cholesterol-lowering diet plan.

Do not drink more than 1 alcoholic drink per day. Alcohol can increase your risk of liver damage while you are taking lomitapide.

If you also take cholestyramine or colesevelam, take these medicines at least 4 hours before or after you take lomitapide. Do not take either of these medicines at the same time you take lomitapide.

What are the possible side effects of 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 using lomitapide and call your doctor at once if you have signs of liver problems, such as:

  • nausea, upper stomach pain;
  • loss of appetite;
  • itching, tired feeling;
  • dark urine, clay-colored stools; or
  • jaundice (yellowing of the skin or eyes).

Common side effects may include:

  • vomiting, stomach pain;
  • diarrhea;
  • gas, indigestion; or
  • constipation.

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?

Many drugs can interact with lomitapide. Not all possible interactions are listed here. Tell your doctor about all your medications and any you start or stop using during treatment with lomitapide, especially:

  • an antidepressant;
  • a blood thinner (warfarin, Coumadin, Jantoven);
  • heart or blood pressure medicine;
  • medicine to treat an infection; or
  • other cholesterol-lowering medications, especially atorvastatin, lovastatin, or simvastatin.

This list is not complete and many other drugs can interact with lomitapide. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Give a list of all your medicines to any healthcare provider who treats you.

Where can I get more information?

Your pharmacist can provide more information about lomitapide.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

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