lomitapide mesylate

FDA Drug Profile — Juxtapid

Drug Details

Generic Name
lomitapide mesylate
Brand Names
Juxtapid
Application Number
NDA203858
Sponsor
Amryt Pharmaceuticals DAC
NDC Codes
11
Dosage Forms
CAPSULE
Routes
ORAL
Active Ingredients
LOMITAPIDE MESYLATE

Indications and Usage

1 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, including those with heterozygous familial hypercholesterolemia (HeFH) ( 1 ). The effect of JUXTAPID on cardiovascular morbidity and mortality has not been determined ( 1 ). 1.1 Homozygous Familial Hypercholesterolemia JUXTAPID is 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). Limitations of Use The safety and effectiveness of JUXTAPID have not been established in patients with hypercholesterolemia who do not have HoFH, including those with heterozygous familial hypercholesterolemia (HeFH). The effect of JUXTAPID on cardiovascular morbidity and mortality has not been determined.