JUXTAPID is contraindicated in pregnancy.
Advise females of reproductive potential that they should have a negative pregnancy test before starting JUXTAPID and that they should use effective contraception while taking JUXTAPID. If oral contraceptives are initiated while taking JUXTAPID, the dose of JUXTAPID may require adjustment. Hormone absorption from oral contraceptives may be incomplete if vomiting or diarrhea occurs while taking JUXTAPID, warranting the use of additional contraceptive methods.
Nursing Mothers: A decision should be made whether to discontinue nursing or discontinue JUXTAPID.
Dietary Supplements [see Warnings and Precautions (5.4)]

Discuss with the patient the importance of taking daily supplements that contain 400 international units vitamin E and at least 200 mg linoleic acid, 210 mg alpha-linolenic acid (ALA), 110 mg eicosapentaenoic acid (EPA), and 80 mg docosahexaenoic acid (DHA).
Gastrointestinal Adverse Reactions [see Warnings and Precautions (5.5)]

Inform the patient that gastrointestinal adverse reactions are common with JUXTAPID. These include, but are not limited to, diarrhea, nausea/vomiting, abdominal pain/discomfort, flatulence, and constipation. Strict adherence to a low-fat diet (<20% of total calories from fat) may reduce these reactions.
Tell the patient that taking JUXTAPID with food may adversely impact gastrointestinal tolerability; therefore, they should take JUXTAPID at least 2 hours after the evening meal, swallowing each capsule whole.
Absorption of oral medications may be affected in patients who develop diarrhea or vomiting. For example, hormone absorption from oral contraceptives may be incomplete, warranting the use of additional contraceptive methods. Patients who develop these symptoms should seek advice from their healthcare provider.
Drug Interactions [see Warnings and Precautions (5.6) and Drug Interactions (7)]

Tell the patient to omit grapefruit juice from his/her diet while on JUXTAPID.
Because multiple drug-drug interactions have been described with JUXTAPID, advise the patient to tell their healthcare provider(s) about all medications, nutritional supplements, and vitamins that they are taking or may be taking while taking JUXTAPID.
Missed Doses

If a dose of JUXTAPID is missed, the normal dose should be taken at the usual time the next day. If dosing is interrupted for more than a week, tell the patient to contact their healthcare provider before restarting treatment.
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MEDICATION GUIDE

MEDICATION GUIDE

JUXTAPID® (JUKS-tuh-pid)
(lomitapide)
capsules

Read this Medication Guide before your treatment.

What is the most important information I should know about JUXTAPID?

JUXTAPID is available only through certified pharmacies that are enrolled in the JUXTAPID REMS Program. Your doctor must be enrolled in the program in order for you to be prescribed JUXTAPID.
There is a registry that collects information about the effects of taking JUXTAPID over time. Ask your doctor for more information about this registry or visit www.JUXTAPID.com or call 1-877-902-4099.

JUXTAPID may cause serious side effects including:

1. Liver pro