To report SUSPECTED ADVERSE REACTIONS, contact Aegerion Pharmaceuticals at 1-855-303-2347 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

DRUG INTERACTIONS
CYP3A4 inhibitors increase exposure to lomitapide. Strong and moderate CYP3A4 inhibitors are contraindicated with JUXTAPID. Patients must avoid grapefruit juice. Do not exceed 30 mg daily of JUXTAPID when used concomitantly with weak CYP3A4 inhibitors, including atorvastatin and oral contraceptives (2.3, 4, 5.6, 7.1, 7.2).
Warfarin: Lomitapide increases plasma concentrations of warfarin. Monitor international normalized ratio (INR) regularly, especially with JUXTAPID dose adjustment (5.8, 7.3).
Simvastatin and lovastatin exposure increase with JUXTAPID. Limit dose when co-administered with JUXTAPID due to myopathy risk (5.7, 7.4).
P-glycoprotein (P-gp) Substrates: Consider dose reduction of P-gp substrate because of possible increased absorption with JUXTAPID (7.5).
Bile Acid Sequestrants: Separate JUXTAPID dosing by at least 4 hours (7.6).
USE IN SPECIFIC POPULATIONS
Nursing Mothers: Discontinue drug or nursing (8.3).
Pediatric Patients: Safety and effectiveness not established (8.4).
See 17 for PATIENT COUNSELING INFORMATION and Medication Guide.

Revised: 4/2015

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FULL PRESCRIBING INFORMATION: CONTENTS*
WARNING: RISK OF HEPATOTOXICITY
1 INDICATIONS AND USAGE
1.1 Homozygous Familial Hypercholesterolemia 2 DOSAGE AND ADMINISTRATION
2.1 Initiation and Maintenance of Therapy 2.2 Administration 2.3 Dosing with Cytochrome P450 3A4 Inhibitors 2.4 Dose Modification Based on Elevated Transaminases 2.5 Dosing in Patients with Renal Impairment 2.6 Dosing in Patients with Baseline Hepatic Impairment 3 DOSAGE FORMS AND STRENGTHS
4 CONTRAINDICATIONS
5 WARNINGS AND PRECAUTIONS
5.1 Risk of Hepatotoxicity 5.2 JUXTAPID REMS Program 5.3 Embryo-Fetal Toxicity 5.4 Reduced Absorption of Fat-Soluble Vitamins and Serum Fatty Acids 5.5 Gastrointestinal Adverse Reactions 5.6 Concomitant Use of CYP3A4 Inhibitors 5.7 Risk of Myopathy with Concomitant Use of Simvastatin or Lovastatin 5.8 Risk of Supratherapeutic or Subtherapeutic Anticoagulation with Warfarin 5.9 Risk of Malabsorption with Rare Hereditary Disorders of Galactose Intolerance 6 ADVERSE REACTIONS
6.1 Clinical Trials Experience 7 DRUG INTERACTIONS
7.1 Moderate and Strong CYP3A4 Inhibitors 7.2 Weak CYP3A4 Inhibitors 7.3 Warfarin 7.4 Simvastatin and Lovastatin 7.5 P-glycoprotein Substrates 7.6 Bile Acid Sequestrants 8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy 8.3 Nursing Mothers 8.4 Pediatric Use 8.5 Geriatric Use 8.6 Females of Reproductive Potential 8.7 Renal Impairment 8.8 Hepatic Impairment 10 OVERDOSAGE
11 DESCRIPTION
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action 12.2 Pharmacodynamics 12.3 Pharmacokinetics 13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility 14 CLINICAL STUDIES
16 HOW SUPPLIED / STORAGE AND HANDLING
17 PATIENT COUNSELING INFORMATION
* Sections or subsections omitted from the full prescribing information are not listed. Close
1 INDICATIONS AND USAGE

1.1 Homozygous Familial HypercholesterolemiaJUXTAPID