LOMITAPIDE

(loe MI ta pide) Brand: Juxtapid

What is the most significant information I must know about lomitapide?

• Do not use lomitapide if you are pregnant.

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

• Grapefruit and grapefruit juice may interact with lomitapide and lead to unwanted side effects. Do not drink grapefruit juice while taking 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 medicine. 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 another treatments to lower total cholesterol in people with homozygous familial hypercholesterolemia (an inherited type of tall 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 medicine guide.

What must I discuss with my healthcare provider till taking lomitapide?

• Lomitapide is accessible only under a particular program called the Juxtapid REMS Program. You should be registered in the program and understand the risks and benefits of taking this medication.

• You must not use lomitapide if you are allergic to it, if you have severe liver malady, or if you are pregnant.

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

· aprepitant;

· cimetidine;

· conivaptan;

· cyclosporine;

· haloperidol;

· imatinib;

· isoniazid;

· an antibiotic--ciprofloxacin, clarithromycin, doxycycline, erythromycin, metronidazole, norfloxacin, telithromycin, tetracycline;

· an antidepressant--desipramine, nefazodone, sertraline;

· antifungal medication--clotrimazole, fluconazole, itraconazole, ketoconazole, posaconazole, voriconazole;

· the hepatitis C medications boceprevir or telaprevir;

· heart or blood pressure medicine--amiodarone, diltiazem, dronedarone, lidocaine, nicardipine, quinidine, verapamil; or

· HIV or AIDS medicine--atazanavir, darunavir when given with ritonavir, delavirdine, efavirenz, fosamprenavir, indinavir, nelfinavir, saquinavir.

• To create certain lomitapide is safety for you, speak your doctor if you have:

· liver disease;

· kidney malady (or if you are on dialysis); or

· hereditary galactose intolerance, severe lactase deficiency, or glucose galactose malabsorption.

• FDA pregnancy category X. This medicine can harm an unborn child or reason birth defects. Do not use lomitapide if you are pregnant. Speak your doctor right away if you become pregnant during treatment. Use effective birth control while you are using this medication.

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

• You may need to have a negative pregnancy test till starting this treatment.

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

How must I take lomitapide?

• Your doctor will perform blood trials to create certain lomitapide is safety for you to take.

• Lomitapide is generally taken once daily, at least 2 hours after your evening meal. Your doctor may occasionally change your doze to create certain you get the excellent results. Follow all directions on your prescription label. Do not take this medication in larger or less amounts or for longer than recommended.

• Take this medication with a full glass of water.

• Do not crush, chew, interrupt, or open a lomitapide capsule. Swallow it intact.

• 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 trials at your doctor's office.

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

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

What happens if I miss a dose?

• Take the missed doze as soon as you remember. Skip the missed doze if it is nearly time for your following scheduled doze. Do not take extra medication to create up the missed dose.

What happens if I overdose?

• Search abnormal medical attention or call the Poison Help line at 1-800-222-1222.

What must 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 drinking alcohol. It may magnify your risk of liver hurt while you are taking lomitapide.

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

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

What are the possible side effects of lomitapide?

• Get abnormal medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your person, lips, tongue, or throat.

• Stop using lomitapide and call your doctor at once if you have signs of a liver problem, such as:

· nausea, upper stomach pain, loss of appetite;

· dark urine, clay-colored stools; or

· itching, or jaundice (yellowing of the skin or eyes).

• General side effects may include:

· vomiting, gas, indigestion, stomach pain;

· diarrhea, constipation;

· chest pain; or

· weight loss.

• This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may message side effects to FDA at 1-800-FDA-1088.

What another drugs will affect lomitapide?

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

· ambrisentan;

· colchicine;

· dabigatran;

· fexofenadine;

· loperamide (Imodium);

· maraviroc;

· saxagliptin or sitagliptin (for type 2 diabetes);

· tolvaptan;

· warfarin, Coumadin;

· birth control pills;

· drugs to treat cancer or leukemia--lapatinib, nilotinib, topotecan, vinblastine;

· heart or blood pressure medicine--aliskiren, digoxin, ranolazine;

· medication to prevent organ transplant rejection--everolimus, sirolimus; or

· another cholesterol-lowering medications, especially atorvastatin, lovastatin, simvastatin.

• This list is not complete and much another drugs can interact with lomitapide. This includes prescription and over-the-counter medicines, vitamins, and herbal commodity. 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, hold this and all another medicines out of the reach of children, never share your medicines with others, and use this medicine only for the indication prescribed.

Disclaim: Each 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 external 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 must be construed to indicate that the drug or drug combination is safety, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the help 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.