Juxtapid

Generic name: lomitapide (loe MI ta pide)
Brand name: Juxtapid
Drug class: Miscellaneous antihyperlipidemic agents

Juxtapid (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.

Juxtapid 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 Juxtapid will lower your risk of heart disease.

Juxtapid is available only under a special program. You must be registered in the program and understand the risks and benefits of this medicine.

Warnings

You should not use Juxtapid 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 Juxtapid.

Tell your doctor about all your current medicines and any you start or stop using. Many drugs can interact with lomitapide, and some drugs should not be used together.

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).

Before taking this medicine

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

• you have severe liver disease;
• you have abnormal liver function tests; or
• you are pregnant.

Many drugs can interact and cause dangerous effects. Some drugs should not be used together with lomitapide. Your doctor may change your treatment plan 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.

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

• 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.

Do not use if you are pregnant. Stop using the medicine and tell your doctor right away if you become pregnant. Lomitapide could harm the unborn baby. Use effective birth control to prevent pregnancy while you are using this medicine.

If you become 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 Juxtapid.

You should not breastfeed while using lomitapide.

Juxtapid is not approved for use by anyone younger than 18 years old.

How should I take Juxtapid?

Juxtapid is usually taken once daily, at least 2 hours after your evening meal. Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose.

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

Take Juxtapid 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 Juxtapid. Take only the type and amount of vitamins or supplements your doctor has prescribed.

You will need frequent medical tests.

Juxtapid is only part of a treatment program that may also include 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.

Dosing information

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.

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.
-Juxtapid should be taken with a full glass of water on an empty stomach at least 2 hours after the evening meal.

What happens if I miss a dose?

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

What happens if I overdose?

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

What to avoid

Avoid eating foods high in fat or cholesterol, or Juxtapid will not be as effective and may cause nausea, vomiting, and stomach pain.

Grapefruit may interact with lomitapide and lead to unwanted side effects. Avoid the use of grapefruit products.

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

Juxtapid side effects

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

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 Juxtapid side effects 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.

What other drugs will affect Juxtapid?

Some medicines can make Juxtapid 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 interact with lomitapide, especially:

• acetaminophen, isotretinoin, methotrexate, or tamoxifen;
• an antidepressant;
• antiviral medicine to treat HIV or hepatitis C;
• 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.