Juxtapid

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

What is Juxtapid?

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.

Important information

Do not use Juxtapid 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 Juxtapid.

Slideshow: Flashback: FDA Drug Approvals 2013

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

You will need frequent blood tests to check your liver function.

Stop using this medicine 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).

Before taking this medicine

Juxtapid 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 Juxtapid if you are allergic to lomitapide, 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 (Stribild, Tybost), darunavir when given with ritonavir, delavirdine, fosamprenavir, indinavir, nelfinavir, ritonavir, saquinavir, tipranavir.

To make sure Juxtapid 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.

FDA pregnancy category X. This medication can harm an unborn baby or cause birth defects. Do not use Juxtapid 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 Juxtapid. Tell your doctor right away if you become pregnant during treatment.

See also: Pregnancy and breastfeeding warnings (in more detail)

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.

Juxtapid 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 this medicine.

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 Juxtapid?

Take Juxtapid exactly as prescribed by your doctor. Your doctor will perform blood tests to make sure lomitapide is safe for you to take.

Juxtapid 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 capsule. Swallow it whole.

Your doctor may have you take vitamin E or essential fatty acid supplements while you are taking this medicine. Take only the type and amount of vitamins or supplements your doctor has prescribed.

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

Juxtapid 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.

Juxtapid 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

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.

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 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 Juxtapid?

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

Avoid eating foods that are high in fat or cholesterol. Juxtapid 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 this medicine.

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

Juxtapid side effects

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

Stop using Juxtapid 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 Juxtapid 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.

See also: Side effects (in more detail)

What other drugs will affect Juxtapid?

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 Juxtapid, 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 Juxtapid.
  • 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.
  • Disclaimer: Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2014 Cerner Multum, Inc. Version: 1.03. Revision Date: 2014-10-07, 8:39:11 AM.

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