Lomitapide oral capsule

What is this medication?

LOMITAPIDE is used in combination with diet and other medicines to lower blood cholesterol levels in patients with a genetic disorder that results in high blood cholesterol levels.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

COMMON BRAND NAME(S): Juxtapid

What should I tell my care team before I take this medication?

They need to know if you have any of these conditions:

• if you often drink alcohol
• intestine problems
• kidney disease
• liver disease
• pancreatic disease
• an unusual or allergic reaction to lomitapide, other medicines, foods, dyes, or preservatives
• pregnant or trying to get pregnant
• breast-feeding

How should I use this medication?

Take this medicine by mouth with a glass of water. Follow the directions on the prescription label. Take this medicine on an empty stomach, at least 2 hours after your evening meal. Do not take with food. Do not cut, crush or chew this medicine. Do not take with grapefruit juice. Take your medicine at regular intervals. Do not take it more often than directed. Do not stop taking except on your doctor's advice.

A special MedGuide will be given to you by the pharmacist with each prescription and refill. Be sure to read this information carefully each time.

Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, the normal dose should be taken at the usual time the next day. If you miss your dose for more than a week, contact your doctor or healthcare professional before restarting treatment.

What may interact with this medication?

Do not take this medicine with any of the following medications:

• aprepitant, fosaprepitant
• berotralstat
• boceprevir
• calcium channel blockers like diltiazem and verapamil
• certain antibiotics like ciprofloxacin, clarithromycin, erythromycin and telithromycin
• certain antiviral medicines for HIV or AIDS
• certain medicines for fungal infections like fluconazole, itraconazole, ketoconazole, posaconazole, and voriconazole
• conivaptan
• crizotinib
• grapefruit juice
• imatinib
• nefazodone

This medicine may also interact with the following medications:

• acetaminophen
• ambrisentan
• bicalutamide
• birth control pills
• certain medicines for blood pressure, heart disease, irregular heart beat
• certain medicines for cholesterol like atorvastatin, lovastatin, simvastatin, cholestyramine, and colestipol
• certain medicines for depression, anxiety, or psychotic disturbances
• certain medicines for diabetes, like saxagliptin and sitagliptin
• certain medicines for stomach problems like cimetidine and ranitidine
• certain medicines that treat or prevent blood clots like warfarin, dabigatran, and ticagrelor
• cilostazol
• colchicine
• cyclosporine
• everolimus
• fexofenadine
• isoniazid
• isotretinoin
• lapatinib
• methotrexate
• nilotinib
• pazopanib
• sirolimus
• supplements like ginkgo biloba and goldenseal
• tamoxifen
• tetracycline
• topotecan
• zileuton

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medication?

To help prevent stomach problems while taking this medicine, you should stay on a low-fat diet. This medicine makes it harder for some nutrients to get into your body. You should take Vitamin E and fatty acids each day while you are taking this medicine. Talk to your doctor or healthcare provider about how to add these to your diet.

Do not become pregnant while taking this medicine. Women should inform their doctor if they wish to become pregnant or think they might be pregnant. There is a potential for serious side effects to an unborn child. Talk to your health care professional or pharmacist for more information. Women who become pregnant while taking this medicine are encouraged to enroll in the pregnancy registry by calling 1-877-902-4099 or visiting www.juxtapid.com.

Birth control pills may not work properly while you are taking this medicine. Talk to your doctor about using an extra or different method of birth control.

This medicine can cause liver injury. The risk of liver injury is increased in patients who drink alcohol while taking this medicine. Do not drink more than one alcoholic drink per day while taking this medicine.

What side effects may I notice from receiving this medication?

Side effects that you should report to your doctor or health care professional as soon as possible:

• allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue
• dark urine
• general ill feeling or flu-like symptoms
• light-colored stools
• loss of appetite, nausea
• right upper belly pain
• unusually weak or tired
• yellowing of the eyes or skin

Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):

• diarrhea
• nausea
• stomach pain
• upset stomach
• vomiting

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medication?

Keep out of the reach of children.

Store at room temperature between 15 and 30 degrees C (59 and 86 degrees F). Throw away any unused medicine after the expiration date.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.