Elinzanetant Interactions

Pregnancy & Breastfeeding

8.1 Pregnancy Risk Summary LYNKUET is contraindicated in pregnancy [see Contraindications (4) ]. If pregnancy occurs during the use of LYNKUET, discontinue treatment. Based on findings from animal reproduction studies, LYNKUET may cause pregnancy loss or stillbirth but not fetal malformations when administered during pregnancy. There are no data on the use of LYNKUET in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. In animal reproduction studies in rats, an increase in total litter loss or stillbirth and a decrease of neonatal pup viability was observed within the range of human therapeutic exposure when dams were treated orally throughout gestation and lactation [i.e., gestation day 6 to lactation day 21]. There was an increase in percentage of pre- and post-implantation embryo loss and decrease in fetal body weights at 16-fold the human therapeutic exposure when rat dams were treated orally prior to mating and through the early embryonic period [i.e., 22 days before mating to post-coitum day 6]. In rabbits, there was marked body weight loss and decreased food consumption in dams treated orally during gestation day 7 to 19 at doses equivalent to human therapeutic exposure (see Data ). Data Animal Data In a fertility and early embryonic development study in female rats, once daily oral doses of elinzanetant were administered 22 days before mating through post-coitum day 6. Increased percentage of pre-implantation and post-implantation embryo loss, resulting in reduced litter size, and lower fetal body weights were seen at the dose of 100 mg/kg/day (14-fold the AUC (0-24) at the human therapeutic dose). These effects were not observed following dosing at 25 mg/kg/day (3-fold the AUC (0-24) at the human therapeutic dose). In an embryo-fetal development study in pregnant rats, once daily oral doses of elinzanetant were administered throughout organogenesis from gestation day 6 to 17. No