Jeselhy Use In Pregnancy & Lactation

Fertility: If JESELHY must be administered to a patient with reproductive potential, the possibility that JESELHY can decrease reproductive function should be considered. Animal studies (in rats) have reported increased apoptotic bodies in the vaginal epithelium, multifocal cysts in the ovaries, white patches in the ovaries, decreased corpora lutea, and proliferation of interstitial glands. In addition, animal studies (in rats and dogs) have reported degeneration of the seminiferous tubules, atrophic changes of the accessory sex glands, and degeneration/necrosis of the germinal epithelium, accompanied by decreased spermatozoa in the epididymis.
Pregnancy: Women of childbearing potential should be instructed to use appropriate contraception during treatment with JESELHY and for an appropriate period after the end of treatment.
In genotoxicity studies, JESELHY induced structural chromosomal aberrations. Men whose partner is of childbearing potential should be instructed to use appropriate contraception during treatment with pimitespib and for an appropriate period after the end of treatment.
Pregnant women or women who may be pregnant should be administered only when the therapeutic benefit is judged to outweigh the risk. An embryo-fetal development study in rats reported growth inhibition, teratogenicity, and embryonic death in embryos and fetuses at exposure doses below the clinical exposure dose (AUC).
Breast-feeding: It is advisable not to breastfeed while taking JESELHY. It may be excreted in human milk, and serious adverse reactions may occur in an infant with exposure to JESELHY through milk.