Juxtapid

Before taking lomitapide,

• tell your doctor and pharmacist if you are allergic to lomitapide, any other medications, or any of the ingredients in lomitapide capsules. Ask your pharmacist or check the Medication Guide for a list of the ingredients.
• tell your doctor if you are taking antifungal medications such as fluconazole (Diflucan), itraconazole (Sporanox), ketoconazole (Nizoral), posaconazole (Noxafil), and voriconazole (Vfend); boceprevir (Victrelis); aprepitant (Emend); ciprofloxacin (Cipro); clarithromycin (Biaxin); crizotinib (Xalkori); diltiazem (Cardizem, Dilacor, Tiazac); erythromycin (E.E.S., E-Mycin, Erythrocin); HIV protease inhibitors such as amprenavir (Agenerase), atazanavir (Reyataz), darunavir (Prezista), fosamprenavir (Lexiva), indinavir (Crixivan), lopinavir (in Kaletra), nelfinavir (Viracept), saquinavir (Invirase), ritonavir (Norvir, in Kaletra), ritonavir and tipranavir (Aptivus), and teleprevir (Incivek); imatinib (Gleevec); nefazodone; telithromycin (Ketek); and verapamil (Calan, Covera, Isoptin, Verelan). Your doctor will probably tell you not to take lomitapide if you are taking one or more of these medications.
• tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention the medications listed in the IMPORTANT WARNING section and any of the following: aliskiren (Tekturna); alprazolam (Xanax); ambrisentan (Letairis); amiodarone (Cordarone, Pacerone); amlodipine (Norvasc, in Caduet); bicalutamide (Casodex); cilostazol (Pletal); certain oral medications for diabetes such as saxagliptin (Onglyza in Kombiglyze) and sitagliptin (Januvia, in Janumet); cimetidine (Tagament); colchicine (Colcrys); dabigatran (Pradaxa); digoxin (Lanoxin); everolimus (Afinitor, Zortress); fexofenadine (Allegra); fluoxetine (Prozac); fluvoxamine (Luvox); isoniazid (INH, Nydrazid); lapatinib (Tykerb); maraviroc (Selzentry); medications that suppress the immune system such as cyclosporine (Gengraf, Neoral, Sandimmune), sirolimus (Rapamune) and tacrolimus (Prograf); nilotinib (Tasigna); oral contraceptives (birth control pills); other cholesterol lowering medications such as atorvastatin (Lipitor, in Caduet, in Liptruzet), lovastatin (Mevacor), and simvastatin (Zocor, in Simcor, in Vytorin); pazopanib (Votrient); ranitidine (Zantac); ranolazine (Ranexa); ticagrelor (Brilinta); tolvaptan (Samsca); topotecan (Hycamtin); warfarin (Coumadin); and zileuton (Zyflo). Your doctor may need to change the doses of your medications or monitor you carefully for side effects. Many other medications may also interact with lomitapide, so be sure to tell your doctor about all the medications you are taking, even those that do not appear on this list.
• tell your doctor what herbal products you are taking, especially ginkgo or goldenseal.
• if you are taking cholestyramine (Questran), colesevelam (WellChol), or colestipol (Colestid), take it 4 hours before or 4 hours after lomitapide.
• tell your doctor if you have or have ever had galactose intolerance or glucose-galactose malabsorption (inherited conditions where the body is not able to tolerate lactose), ongoing stomach or intestinal problems, or pancreas or kidney disease.
• Tell your doctor if you are pregnant or plan to become pregnant. If you are female who can become pregnant, you will need to take a pregnancy test before you begin taking lomitapide. If you can become pregnant, you should use effective birth control while taking lomitapide. Talk to your doctor about birth control methods that will work for you. If you become pregnant while taking lomitapide, stop taking the medication and call your doctor immediately. Lomitapide can harm the fetus.
• tell your doctor if you are breast-feeding. You should not breast-feed while you are 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 eating foods that are high in fat or cholesterol. Lomitapide 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 lomitapide.

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

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 lomitapide, 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.

• Aegerion Pharmaceuticals, Inc.

• Take Juxtapid exactly as your doctor tells you to take it.
• Your doctor will tell you how much Juxtapid to take and when to take it.
• Your doctor may change your dose of Juxtapid if needed.
• Do not change your Juxtapid dose yourself.
• Take Juxtapid 1 time each day at least 2 hours after your evening meal.
• Take Juxtapid with water.
• You should not take Juxtapid with food. Taking Juxtapid with food may cause stomach problems.
• Take Juxtapid capsules whole. Do not open, crush, dissolve, or chew capsules before swallowing. If you cannot swallow Juxtapid capsules whole, tell your doctor. You may need a different medicine.
• If you take a medicine that lowers cholesterol by binding bile acids, such as colesevelam or cholestyramine, take it at least 4 hours before or 4 hours after you take Juxtapid. Ask your doctor if you are not sure if you take these medicines.
• To help lower the chance of stomach problems, stay on a low-fat diet. Ask your doctor about talking to a dietician to learn what you should eat while taking Juxtapid. Juxtapid makes it harder for some nutrients to get into your body. Take Vitamin E and fatty acids each day while you take Juxtapid. Ask your doctor, nurse, or dietician how to add them to your diet.
• If you take too much Juxtapid , call your doctor right away.
• Do not stop Juxtapid unless your doctor tells you to stop it.
• If you miss a dose of Juxtapid, take your usual dose the next day at the usual time. If you stop taking Juxtapid for more than a week, talk to your doctor before restarting treatment.

• Store Juxtapid at room temperature, between 68°F and 77°F (20°C and 25°C).
• Keep Juxtapid in a tightly closed container.
• Keep Juxtapid capsules dry.
• Safely throw away medicine that is out of date or no longer needed.

Keep Juxtapid and all medicines out of the reach of children.

• Cholesterol
• Complete Blood Count (CBC)
• High Cholesterol: Frequently Asked Questions

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

Lomitapide 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 lomitapide capsule. Swallow it whole.

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 tests at your doctor's office.

Lomitapide 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.

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

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.

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

Take this medicine with a full glass of water.

Do not crush, chew, break, or open a capsule. Swallow the capsule whole.

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.

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.

Common side effects of Juxtapid include: increased serum alanine aminotransferase, increased serum aspartate aminotransferase, abdominal distention, abdominal distress, abdominal pain, constipation, diarrhea, dyspepsia, fever, nausea, vomiting, and flatulence. See below for a comprehensive list of adverse effects.

Maximum dose should not exceed 40 mg daily since lomitapide exposure in these patients increased approximately 50%.

Lomitapide may cause fetal harm when administered to a pregnant woman. Animal studies at 2- to 5-times the human dose resulted in umbilical hernia, gastroschisis, imperforate anus, alterations in heart shape and size, kinking and skeletal malformations of the tail, delayed ossification of cranial, vertebral and pelvic bones, medially rotated or short limbs, absent or fused digits on paws, cleft palate, open eye lids, and lowset ears. There are no controlled data in human pregnancy. Females of reproductive potential should have a negative pregnancy test before starting lomitapide. To monitor the outcomes of pregnant women exposed to lomitapide, a pregnancy registry has been established. Physicians are encouraged to register patients and pregnant women are encouraged to register themselves at www.JUXTAPID.com or call the Global Lomitapide Pregnancy Exposure Registry (PER) at 1-877-902-4099. US FDA pregnancy category X: Studies in animals or humans have demonstrated fetal abnormalities and/or there is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience, and the risks involved in use of the drug in pregnant women clearly outweigh potential benefits.

Use of lomitapide is contraindicated. US FDA pregnancy category: X Comments: Encourage use of adequate methods of contraception. If lomitapide is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to a fetus.

No information exists on the use of lomitapide during breastfeeding. Lomitapide should not be used during breastfeeding due to possible disruption of infant lipid metabolism.

UK: A decision should be made to discontinue breastfeeding or discontinue the drug, taking into account the importance of the drug to the mother. US: Use of lomitapide is contraindicated. Excreted into human milk: Unknown (a small amount of another drug in this class is excreted in human milk) The effects in the nursing infant are unknown. .