Lomitapide

Generic Name: lomitapide (loe-MI-ta-pide)
Brand Name: Juxtapid

Lomitapide may increase the risk of liver problems. The risk may be greater if you already have liver problems. Liver function tests will be performed while you use lomitapide to check for side effects. Contact your doctor right away if you experience dark urine; fever; flu-like symptoms; nausea, vomiting, or stomach pain that gets worse, does not go away, or changes; pale stools; unusual tiredness; or yellowing of the skin or eyes.


Lomitapide is used for:

Lowering high cholesterol in certain patients. It is used along with an appropriate diet and other cholesterol treatments.

Lomitapide is a lipid-lowering agent. It works by preventing the production of cholesterol.

Do NOT use lomitapide if:

  • you are allergic to any ingredient in lomitapide
  • you are pregnant, think you may be pregnant, or are planning to become pregnant
  • you have moderate to severe liver problems or unexplained abnormal liver function tests
  • you have certain hereditary problems (eg, galactose intolerance, Lapp lactase deficiency, glucose-galactose malabsorption)
  • you are taking aprepitant, azole antifungals (eg, fluconazole, itraconazole, voriconazole), ciprofloxacin, clarithromycin, conivaptan, crizotinib, diltiazem, erythromycin, fosaprepitant, imatinib, mibefradil, nefazodone, protease inhibitors (eg, boceprevir, ritonavir), telithromycin, or verapamil

Contact your doctor or health care provider right away if any of these apply to you.

Slideshow: Flashback: FDA Drug Approvals 2013

Before using lomitapide:

Some medical conditions may interact with lomitapide. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

  • if you are pregnant, planning to become pregnant, or are breast-feeding
  • if you are able to become pregnant
  • if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
  • if you have allergies to medicines, foods, or other substances
  • if you are on dialysis or have a history of kidney problems, liver problems (eg, liver problems while taking other medicines), stomach or bowel problems, or pancreas problems
  • if you drink alcohol
  • if you take medicines that may harm the liver (eg, acetaminophen, amiodarone, isotretinoin, methotrexate, tamoxifen, tetracycline antibiotics). Ask your doctor if you are unsure if any of your medicines might harm the liver

Some MEDICINES MAY INTERACT with lomitapide. Tell your health care provider if you are taking any other medicines, especially any of the following:

  • Many prescription and nonprescription medicines (eg, used for aches and pains, acne, allergies, anxiety, asthma, birth control, blood clotting problems, blood thinning, blood vessel problems, cancer, depression or other mental or mood problems, diabetes, gout, high blood pressure, high cholesterol, HIV, immune system suppression, indigestion or reflux, infections, irregular heartbeat or other heart problems, low blood sodium levels, pulmonary arterial hypertension [PAH], rheumatoid arthritis, sleep, stomach or bowel problems), multivitamin products, and herbal or dietary supplements (eg, ginkgo, goldenseal, St. John's wort) because they may interact with lomitapide. Ask your doctor or pharmacist if you are unsure if any of your medicines might interact with lomitapide

This may not be a complete list of all interactions that may occur. Ask your health care provider if lomitapide may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use lomitapide:

Use lomitapide as directed by your doctor. Check the label on the medicine for exact dosing instructions.

  • Lomitapide comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get lomitapide refilled.
  • Take lomitapide by mouth on an empty stomach at least 2 hours after the evening meal. Taking lomitapide with food may cause stomach problems.
  • Swallow lomitapide whole with a glass of water. Do not open, crush, dissolve, or chew before swallowing. If you cannot swallow lomitapide whole, tell your doctor. You may need a different medicine.
  • Do not eat grapefruit or drink grapefruit juice while you use lomitapide.
  • If you also take cholestyramine, colesevelam, or colestipol, do not take it within 4 hours before or after taking lomitapide. Check with your doctor if you have questions.
  • If you miss a dose of lomitapide, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once. If you miss taking lomitapide for more than a week, contact your doctor before you start to take it again.

Ask your health care provider any questions you may have about how to use lomitapide.

Important safety information:

  • Dizziness may occur while you take lomitapide. Use lomitapide with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
  • Do NOT change your dose or stop taking lomitapide without checking with your doctor.
  • Follow the low-fat diet given to you by your health care provider. This may help to decrease the risk of stomach or bowel problems.
  • You may need to take certain dietary supplements (eg, vitamin E, fatty acids) while taking lomitapide. Be sure to follow the directions provided by your doctor.
  • Drinking alcohol while taking lomitapide may increase the risk of liver problems. Do not drink more than 1 drink with alcohol in it per day while you are taking lomitapide. Discuss any questions or concerns with your doctor.
  • If vomiting or diarrhea occurs, the effectiveness of other oral medicines may be affected. If you take birth control pills and you develop vomiting or diarrhea, you will need to use an extra form of birth control (eg, condoms). Contact your doctor if you develop vomiting or diarrhea while taking lomitapide.
  • If you may become pregnant, you must have a negative pregnancy test before beginning treatment with lomitapide. You must also use an effective form of birth control while you take lomitapide. If you have questions about effective birth control or if you have any questions or concerns, talk with your doctor.
  • Lab tests, including liver function, may be performed while you use lomitapide. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
  • Lomitapide should be used with extreme caution in CHILDREN; safety and effectiveness in children have not been confirmed.
  • PREGNANCY and BREAST-FEEDING: Do not use lomitapide if you are pregnant. It may cause harm to the fetus. Avoid becoming pregnant while you are taking it. If you think you may be pregnant, contact your doctor right away. It is not known if lomitapide is found in breast milk. Do not breast-feed while taking lomitapide.

Possible side effects of lomitapide:

All medicines may cause side effects, but many people have no, or minor side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Constipation; diarrhea; dizziness; gas; indigestion; mild stomach cramps, pain, or discomfort; nausea; tiredness; vomiting; weight loss.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); chest pain; irregular heartbeat; severe or persistent nausea, vomiting, diarrhea, or stomach pain; stomach swelling; symptoms of liver problems (eg, dark urine; fever; flu-like symptoms; stomach pain that gets worse, does not go away, or changes; pale stools; unusual tiredness; yellowing of the skin or eyes).

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.

Proper storage of lomitapide:

Store lomitapide at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Store in a tightly-closed container away from heat, moisture, and light. Do not store in the bathroom. Keep lomitapide out of the reach of children and away from pets.

General information:

  • If you have any questions about lomitapide, please talk with your doctor, pharmacist, or other health care provider.
  • Lomitapide is to be used only by the patient for whom it is prescribed. Do not share it with other people.
  • If your symptoms do not improve or if they become worse, check with your doctor.
  • Check with your pharmacist about how to dispose of unused medicine.

This information should not be used to decide whether or not to take lomitapide or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about lomitapide. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to lomitapide. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your health care provider for complete information about the risks and benefits of using lomitapide.

Issue Date: December 3, 2014
Database Edition 14.4.1.003
Copyright © 2014 Wolters Kluwer Health, Inc.

Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using this medicine.

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