Pregnancy Contraindicated in pregnant women Drug exposure early in pregnancy may increase the risk of early pregnancy loss Discontinue elagolix if pregnancy occurs during treatment The limited human data with use in pregnant women are insufficient in determining whether there is a risk for major birth defects or miscarriage; although 2 cases of congenital malformations were reported in clinical trials with elagolix, no pattern was identified and miscarriages were reported at a similar incidence across treatment groups Animal data When pregnant rats and rabbits were orally dosed with elagolix during the period of organogenesis, postimplantation loss was observed in pregnant...