Please note, this OEL/ADE monograph also applies to degarelix acetate (CAS RN 934016-19-0) and degarelix acetate hydrate (CAS RN 934246-14-7). Degarelix is a long-acting synthetic peptide with gonadotrophin-releasing hormone (GnRH) antagonistic properties. It is used for the management of advanced prostate cancer. Degarelix is a synthetic derivative of GnRH decapeptide, the ligand of the GnRH receptor. Gonadotropin and androgen production result from the binding of endogenous GnRH to the GnRH receptor. Degarelix antagonizes the GnRH receptor, which in turn blocks the release of luteinizing hormone (LH) and follicle-stimulating hormone (FSH) from the pituitary. Luteinizing hormone (LH) and FSH decrease in a concentration-dependent manner. The reduction in LH leads to a decrease in testosterone release from the testes, which slows the growth and reduces the size of prostate cancers.
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), as well as PIC/S and ANVISA requirements, and to obtain the following information:
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Affygility Solutions’ 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.