Lomitapide, Oral

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KEY POINTS

• This medicine is taken by mouth to lower cholesterol in people who have homozygous familial hypercholesterolemia. Take it exactly as directed.
• Keep all appointments for tests to see how this medicine affects you.
• This medicine may cause serious liver problems or other unwanted side effects. Tell your healthcare provider if you have any side effects that are serious, continue, or get worse.
• Tell all healthcare providers who treat you about all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take.

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What are other names for this medicine?

Type of medicine: microsomal triglyceride transfer protein (MTP) inhibitor; cholesterol-lowering medicine

Generic and brand names: lomitapide, oral; Juxtapid

What is this medicine used for?

This medicine is taken by mouth to lower cholesterol in people who have inherited a gene that causes high levels of LDL (homozygous familial hypercholesterolemia). It is not used to lower cholesterol in people who do not have this condition.

This medicine is available only through certified pharmacies that are enrolled in a special program. Your healthcare provider must also be enrolled in the program in order for you to be prescribed this medicine. For more information call 1-855-898-2743.

This medicine may be used to treat other conditions as determined by your healthcare provider.

What should my healthcare provider know before I take this medicine?

Before taking this medicine, tell your healthcare provider if you have ever had:

• An allergic reaction to any medicine
• A blockage in the intestines, Crohn's disease, ulcerative colitis, or severe constipation
• Kidney problems
• Lactase deficiency or problems digesting galactose or glucose
• Liver disease
• Pancreas problems
• Problems with alcohol abuse or if you regularly drink alcohol

This medicine may interact with many other prescription and non-prescription medicines, vitamins, and herbal supplements. Ask your healthcare provider or pharmacist to make sure you can take this medicine with your other medicines. Tell your healthcare provider about any new medicines you might take even for only a short time.

Females of childbearing age: This medicine has been reported to cause birth defects. Read the information that comes in the medicine package. You must have a negative pregnancy test before you start taking this medicine. Use an effective birth control method while you are taking this medicine. Talk with your healthcare provider about effective methods of birth control. This medicine may make hormonal birth control less effective. Stop taking this medicine at the first sign that you may be pregnant and contact your healthcare provider right away. Do not breast-feed while taking this medicine.

How do I take it?

Read the Medication Guide that comes in the medicine package when you start taking this medicine and each time you get a refill.

Check the label on the medicine for directions about your specific dose. Use this medicine exactly as your healthcare provider prescribes. Your healthcare provider may need to change your dose often. Do not change your dose or stop using this medicine without your healthcare provider’s approval. If you stop taking this medicine for more than 1 week, talk with your healthcare provider before restarting your treatment. Do not use more of it or use it longer than prescribed.

Check with your healthcare provider before using this medicine in children under age 18.

Take this medicine with a full glass of water at least 2 hours after your evening meal. To prevent stomach problems, do NOT take this medicine with food. Do not break, crush, or chew the capsules. Swallow them whole with a glass of water.

Your healthcare provider may tell you to take certain vitamin E and fatty acid supplements. This medicine decreases affects the way your body absorbs these nutrients. Take these supplements or other medicines exactly as directed by your provider.

What if I miss a dose?

If you miss a dose, take it as soon as you remember unless it is almost time for the next scheduled dose. In that case, skip the missed dose and take the next one as directed. Do not take double doses. If you are not sure of what to do if you miss a dose, or if you miss more than one dose, contact your healthcare provider.

What if I overdose?

If you or anyone else has intentionally taken too much of this medicine, call 911 or go to the emergency room right away. If you pass out, have seizures, weakness or confusion, or have trouble breathing, call 911. If you think that you or anyone else may have taken too much of this medicine, call the poison control center. Do this even if there are no signs of discomfort or poisoning. The poison control center number is 800-222-1222.

Symptoms of an acute overdose may include: nausea, vomiting, stomach pain, diarrhea.

What should I watch out for?

This medicine may cause serious liver problems. You need liver tests before you start this medicine and regularly while you are receiving this medicine. Keep all appointments. If you develop nausea, vomiting, a fever, stomach pain, unexplained loss of appetite, itching, yellowing of your eyes or skin, light-colored bowel movements, dark urine, or severe tiredness or weakness, contact your healthcare provider right away. These may be signs of a liver problem.

You will need to have blood tests regularly to see how this medicine affects you. Keep all appointments for these tests.

A low-fat diet and regular exercise are important to reduce cholesterol. Follow your healthcare provider's advice.

Alcohol may increase the risk of liver problems. Do not drink alcohol while you are taking this medicine unless your healthcare provider approves.

Adults over the age of 65 may be at greater risk for side effects. Talk with your healthcare provider about this.

If you need emergency care, surgery, lab tests, or dental work, tell the healthcare provider or dentist you are taking this medicine.

What are the possible side effects?

Along with its needed effects, your medicine may cause some unwanted side effects. Some side effects may be very serious. Some side effects may go away as your body adjusts to the medicine. Tell your healthcare provider if you have any side effects that continue or get worse.

Life-threatening (Report these to your healthcare provider right away. If you cannot reach your healthcare provider right away, get emergency medical care or call 911 for help.): Allergic reaction (hives; itching; rash; trouble breathing; tightness in your chest; swelling of your lips, tongue, and throat).

Serious (Report these to your healthcare provider right away.): Yellowing of your skin or eyes; dark urine; light-colored bowel movements; unexplained loss of appetite; severe nausea, vomiting, or stomach pain; severe diarrhea; decreased urine; itching; unexplained fever; severe tiredness or weakness; chest pain; irregular heartbeat; unexplained muscle pain.

Other: Mild nausea or vomiting, mild stomach cramps, heartburn, gas, diarrhea, constipation, weight loss, dizziness, tiredness, headache, runny or stuffy nose, sore throat, back pain.

What products might interact with this medicine?

When you take this medicine with other medicines; it can change the way this or any of the other medicines work. Nonprescription medicines; vitamins; natural remedies; and certain foods may also interact. Using these products together might cause harmful side effects. Talk to your healthcare provider if you are taking:

• Acetaminophen and medicines that contain acetaminophen
• Aliskiren (Tekturna) and aliskiren/hydrochlorothiazide (Tekturna HCT)
• Alprazolam (Xanax)
• Antibiotics such as chloramphenicol, ciprofloxacin (Cipro), clarithromycin (Biaxin), doxycycline (Doryx, Monodox, Vibramycin), erythromycin (E.E.S., Ery-Tab, Erythrocin), isoniazid, metronidazole, minocycline (Dynacin, Minocin, Solodyn), rifabutin (Mycobutin), rifampin (Rifadin), rifapentine (Priftin), telithromycin (Ketek), and tetracycline
• Antidepressants such as desipramine (Norpramin), fluoxetine (Prozac), fluvoxamine (Luvox), mirtazapine (Remeron), nefazodone, sertraline (Zoloft), trazodone, and venlafaxine (Effexor)
• Antifungal medicines such as clotrimazole, fluconazole (Diflucan), itraconazole (Sporanox), ketoconazole (Nizoral), posaconazole (Noxafil), and voriconazole (Vfend)
• Antihistamines such as azelastine (Astelin, Astepro), cetirizine (Zyrtec), clemastine (Tavist), desloratadine (Clarinex), fexofenadine (Allegra), and loratadine (Alavert, Claritin)
• Antipsychotic medicines such as iloperidone (Fanapt), lurasidone (Latuda), paliperidone (Invega), pimozide (Orap), risperidone (Risperdal)
• Antiseizure medicines such as carbamazepine (Carbatrol, Epitol, Equetro, Tegretol), oxcarbazepine (Trileptal), phenobarbital, phenytoin (Dilantin, Phenytek), and primidone (Mysoline)
• Antiviral medicines such as ombitasvir/paritaprevir/ritonavir/dasabuvir (Viekira) and simeprevir (Olysio)
• Barbiturates such as butabarbital (Butisol), pentobarbital (Nembutal), phenobarbital, and secobarbital (Seconal)
• Bosentan (Tracleer)
• Cancer medicines such as abiraterone (Zytiga), bicalutamide (Casodex), bosutinib (Bosulif), carfilzomib (Kyprolis), ceritinib (Zykadia), crizotinib (Xalkori), dasatinib (Sprycel), daunorubicin, doxorubicin (Doxil), enzalutamide (Xtandi), etoposide, idarubicin (Idamycin), idelalisib (Zydelig), imatinib (Gleevec), lapatinib (Tykerb), mitotane (Lysodren), nilotinib (Tasigna), pazopanib (Votrient), sunitinib (Sutent), tamoxifen, topotecan (Hycamtin), vandetanib (Caprelsa), vemurafenib (Zelboraf), vinblastine, and vincristine (Marqibo)
• Colchicine (Colcrys)
• Corticosteroids such as dexamethasone, hydrocortisone (A-Hydrocort, Cortef), methylprednisolone (Medrol, Solu-Medrol), and prednisolone (Omnipred, Orapred, Prelone)
• Danazol
• Dextromethorphan/quinidine (Nuedexta)
• Diabetes medicines such as linagliptin (Tradjenta), saxagliptin (Onglyza), and sitagliptin (Januvia)
• Digoxin (Lanoxin)
• Eliglustat (Cerdelga)
• Everolimus (Afinitor, Zortress)
• Heart medicines such as amiodarone (Cordarone, Pacerone), amlodipine (Norvasc), amlodipine/atorvastatin (Caduet), carvedilol (Coreg), diltiazem (Cardizem, Cartia, Tiazac), dronedarone (Multaq), felodipine, hydralazine, irbesartan (Avapro), isradipine (DynaCirc), losartan (Cozaar), nicardipine (Cardene), nifedipine (Adalat CC, Procardia), nisoldipine (Sular), quinidine, ranolazine (Ranexa), and verapamil (Calan, Covera, Verelan)
• HIV medicines such as atazanavir (Reyataz), darunavir (Prezista), delavirdine (Rescriptor), efavirenz (Sustiva), elvitegravir/cobicistat/emtricitabine/tenofovir (Stribild), etravirine (Intelence), fosamprenavir (Lexiva), indinavir (Crixivan), lopinavir/ritonavir (Kaletra), maraviroc (Selzentry), nelfinavir (Viracept), nevirapine (Viramune), ritonavir (Norvir), saquinavir (Invirase), and tipranavir (Aptivus)
• Hormonal birth control implants, IUDs, patches, pills, shots, and vaginal rings (Talk to your healthcare provider if you need birth control.)
• Immunosuppressants such as cyclosporine (Gengraf, Neoral, Sandimmune), sirolimus (Rapamune), and tacrolimus (Astagraf, Prograf, Protopic)
• Isotretinoin (Absorica, Amnesteem, Claravis, Myorisan, Zenatane)
• Ivacaftor (Kalydeco)
• Loperamide (Imodium)
• Medicines to block or prevent stomach acid such as cimetidine (Tagamet), esomeprazole (Nexium), lansoprazole (Prevacid), nizatidine (Axid), omeprazole (Prilosec), rabeprazole (AcipHex), and ranitidine (Zantac)
• Medicines to treat low sodium levels such as conivaptan (Vaprisol) and tolvaptan (Samsca)
• Medicines to treat or prevent blood clots such as apixaban (Eliquis), cilostazol (Pletal), dabigatran (Pradaxa), rivaroxaban (Xarelto), ticagrelor (Brilinta), and warfarin (Coumadin)
• Methotrexate (Otrexup, Rasuvo, Rheumatrex, Trexall)
• Narcotic pain medicines such as fentanyl (Abstral, Actiq, Duragesic, Fentora, Sublimaze), hydrocodone (Hysingla, Zohydro), methadone (Dolophine, Methadose), morphine (Kadian, MS Contin), and oxycodone (OxyContin, Roxicodone)
• Natural remedies such as ginkgo, goldenseal, licorice, milk thistle, red yeast rice, and St. John’s wort
• Nausea medicines such as aprepitant (Emend), fosaprepitant (Emend), and ondansetron (Zofran)
• Other cholesterol-lowering medicines such as atorvastatin (Lipitor), cholestyramine (Prevalite), colesevelam (Welchol), colestipol (Colestid), fluvastatin (Lescol), lovastatin (Altoprev), mipomersen (Kynamro), pravastatin (Pravachol), rosuvastatin (Crestor), and simvastatin (Zocor) (Take cholestyramine, colesevelam, and colestipol at least 4 hours before or 4 hours after you take this medicine.)
• Quinine
• Selegiline (Eldepryl, Emsam, Zelapar)
• Silodosin (Rapaflo)
• Stimulants such as armodafinil (Nuvigil) and modafinil (Provigil)
• Zileuton (Zyflo)

Do NOT eat or drink products that contain grapefruit, Seville oranges, and tangelos at any time while you are taking this medicine. These fruits and juices affect the way this medicine works and increase your risk of serious side effects. Talk with your healthcare provider or pharmacist about this.

Do not drink alcohol while you are taking this medicine unless your healthcare provider approves.

If you are not sure if your medicines might interact, ask your pharmacist or healthcare provider. Keep a list of all your medicines with you. List all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take. Be sure that you tell all healthcare providers who treat you about all the products you are taking.

How should I store this medicine?

Store this medicine at room temperature. Keep the container tightly closed. Protect it from heat, high humidity, and bright light.

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This advisory includes selected information only and may not include all side effects of this medicine or interactions with other medicines. Ask your healthcare provider or pharmacist for more information or if you have any questions.

Ask your pharmacist for the best way to dispose of outdated medicine or medicine you have not used. Do not throw medicine in the trash.

Keep all medicines out of the reach of children.

Do not share medicines with other people.