Venetoclax has shown to be effective for the treatment of patients with chronic lymphocytic leukemia (CLL) with 17p depletion (deletion of the short arm of chromosome 17), in which have received at least one prior therapy. It is marketed under the brand name Venclexta® in the United Stated and Venclyxto in Europe. Venetoclax is an orally bioavailable, selective small molecule inhibitor of the anti-apoptotic protein Bcl-2, with potential antineoplastic activity. Venetoclax mimics BH3-only proteins, the native ligands of Bcl-2 and apoptosis activators by binding to the hydrophobic groove of Bcl-2 proteins, thereby repressing Bcl-2 activity resulting in restoration of intrinsic apoptotic processes in tumor cells. Bcl-2 protein is overexpressed in some cancers and plays an important role in the regulation of apoptosis. Its expression is associated with increased drug resistance and tumor cell survival; therefore, venetoclax activates processes in tumor cells that lead to their cell death.
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.