HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use JUXTAPID safely and effectively. See full prescribing information for JUXTAPID.
JUXTAPID® (lomitapide) capsules, for oral use
Initial U.S. Approval: 2012
WARNING: RISK OF HEPATOTOXICITY See full prescribing information for complete boxed warning.
JUXTAPID can cause elevations in transaminases (5.1).

Measure alanine and aspartate aminotransferases (ALT, AST), alkaline phosphatase, and total bilirubin before initiating treatment and then ALT and AST regularly as recommended (2.4, 5.1).
During treatment, adjust the dose of JUXTAPID if the ALT or AST is ≥3 times the upper limit of normal (ULN) (2.4, 5.1).
Discontinue JUXTAPID for clinically significant liver toxicity (2.4, 5.1).
JUXTAPID increases hepatic fat (hepatic steatosis) with or without concomitant increases in transaminases (5.1).

Hepatic steatosis associated with JUXTAPID may be a risk factor for progressive liver disease, including steatohepatitis and cirrhosis (5.1).
Because of the risk of hepatotoxicity, JUXTAPID is available only through a restricted program called the JUXTAPID REMS Program (5.2).

INDICATIONS AND USAGE
JUXTAPID is a microsomal triglyceride transfer protein inhibitor indicated as an adjunct to a low-fat diet and other lipid-lowering treatments, including LDL apheresis where available, to reduce low-density lipoprotein cholesterol (LDL-C), total cholesterol (TC), apolipoprotein B (apo B), and non-high-density lipoprotein cholesterol (non-HDL-C) in patients with homozygous familial hypercholesterolemia (HoFH) (1).

Limitations of Use

The safety and effectiveness of JUXTAPID have not been established in patients with hypercholesterolemia who do not have HoFH (1).
The effect of JUXTAPID on cardiovascular morbidity and mortality has not been determined (1).
DOSAGE AND ADMINISTRATION
Before treatment, measure ALT, AST, alkaline phosphatase, and total bilirubin; obtain a negative pregnancy test in females of reproductive potential; and initiate a low-fat diet supplying <20% of energy from fat (2.1).
Initiate treatment at 5 mg once daily. Titrate dose based on acceptable safety/tolerability: increase to 10 mg daily after at least 2 weeks; and then, at a minimum of 4-week intervals, to 20 mg, 40 mg, and up to the maximum recommended dose of 60 mg daily (2.1).
Due to reduced absorption of fat-soluble vitamins/fatty acids: Take daily vitamin E, linoleic acid, alpha-linolenic acid (ALA), eicosapentaenoic acid (EPA), and docosahexaenoic acid (DHA) supplements (2.1, 5.4).
Take once daily, whole, with water and without food, at least 2 hours after evening meal (2.2).
Patients with end-stage renal disease on dialysis or with baseline mild hepatic impairment should not exceed 40 mg daily (2.5, 2.6).
DOSAGE FORMS AND STRENGTHS
Capsules: 5 mg, 10 mg, 20 mg, 30 mg, 40 mg, and 60 mg (3).

CONTRAINDICATIONS
Pregnancy (4).
Concomitant use with strong or moderate CYP3A4 inhibitors (4).
Moderate or severe hepatic impairment or active liver disease including unexplained persistent abnormal liver function tests (4).
WARNINGS AND PRECAUTIONS
Embryo-Fetal Toxicity: Females of Reproductive Potential should have a negative pregnancy test before starting JUXTAPID and use contraception during treatment (5.3).
Gastrointestinal adverse reactions occur in 93% of