Lomitapide

Generic name: Lomitapide
Brand names: Juxtapid
Dosage form: oral capsule (10 mg; 20 mg; 30 mg; 5 mg)
Drug class: Miscellaneous antihyperlipidemic agents

Usage of Lomitapide

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.

Lomitapide side effects

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.

Before taking Lomitapide

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.

Relate drugs

How to use Lomitapide

Usual Adult Dose for Hyperlipidemia:

Initial dose: 5 mg orally once a dayMaintenance 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 dayComments: -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:

Warnings

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).

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 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.

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