Please note, this OEL/ADE monograph also applies to elagolix sodium (CAS RN 832720-36-2). Elagolix is a nonpeptide gonadotropin-releasing hormone (GnRH) antagonist indicated for the management of moderate to severe pain associated with endometriosis. Elagolix is a nonpeptide small molecule GnRH receptor antagonist that inhibits endogenous GnRH signaling by binding reversibly with high affinity to human GnRH receptors in the pituitary gland (Kd = 0.054 nM, Ki = 0.9 nM cloned receptor binding, 1.5 nM cloned receptor function). This results in dose-dependent suppression of luteinizing hormone (LH) and follicle-stimulating hormone (FSH), leading to decreased blood concentrations of the ovarian sex hormones, estradiol and progesterone. Endometriosis develops when there is abnormal growth, or lesions, of uterine tissue outside the uterus. Lesions frequently develop on the ovaries, fallopian tubes, and other pelvic organs causing pain, and are dependent upon the estrogen hormone.
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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