Lomitapide 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). Lomitapide directly binds and inhibits microsomal triglyceride transfer protein (MTP), which resides in the lumen of the endoplasmic reticulum. This inhibits the synthesis of chylomicrons and very low density lipoproteins (VLDL), thereby slowing the production of cholesterol in the body. The reduced production of cholesterol decreases the amount of cholesterol that builds up on the walls of the arteries and blocks blood flow to the heart, brain, and other parts of the body.
Affygility Solutions has an occupational exposure limit (OEL) and control band assignment for this active pharmaceutical ingredient (API). This monograph also contains the acceptable daily exposure (ADE) value.
OEL Fastrac monographs are a cost-effective and convenient way to meet the requirements for PDEs (ADEs) contained in the EMA Guideline on setting health based exposure limits for use in risk identification in the manufacture of different medicinal products in shared facilities (EMA/CHMP/CVMP/SWP/169430/2012), and to obtain the following information:
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Affygility Solutions’s OEL Fastrac service is an user-friendly system that enables us to make confident decisions and focus on moving the compound safely through our facility. We can quickly access the database to determine if a new drug is within the OEL Fastrac library, and if so, immediately download a detailed OEL banding report. The OEL Fastrac system has been a helpful tool in our overall EH&S program.