Livtencity Use In Pregnancy & Lactation

Effects on fertility: Fertility studies were not conducted in humans with maribavir. No effects on fertility or reproductive performance were noted in rats in a combined fertility and embryofetal development study, however, a decrease in sperm straight-line velocity was observed at doses ≥100 mg/kg/day [which is estimated to be less than the human exposure at the recommended human dose (RHD)]. Although an increase in testes weight was observed in the 6-month repeat-dose toxicity study in rats and a decrease observed in the combined fertility and embryofetal development study, neither were accompanied with any microscopic changes and were not considered adverse. There were no effects on female reproductive organs in rats and no effects either in males or female monkeys.
Use in pregnancy: There is no clinical experience with maribavir in pregnant women. In a combined fertility and embryofetal development study, maribavir was administered to male and female rats at oral doses of 100, 200, or 400 mg/kg/day. Females were dosed for 15 consecutive days prior to pairing, throughout pairing, and up to gestation day (GD) 17, while males were dosed 29 days prior to mating and throughout mating. A decrease in the number of viable fetuses and increase in early resorptions and post-implantation losses were observed at ≥100 mg/kg/day (at exposures approximately half the human exposure at the RHD). Intermittent reduced body weight gain was observed in pregnant animals at ≥200 mg/kg/day.
Maribavir had no effect on embryo-fetal growth or development at dose levels up to 400 mg/kg/day, at exposures similar to those observed in humans at the RHD.
No significant toxicological effects on embryo-fetal growth or development were observed in rabbits when maribavir was administered at oral doses up to 100 mg/kg/day from GD 8 to 20, at exposures approximately half the human exposure at the RHD.
In the pre- and postnatal developmental toxicity study maribavir was administered to pregnant rats at oral doses of 50, 150, or 400 mg/kg/day from GD 7 to postnatal day (PND) 21. A delay in developmental milestones was observed, including pinna detachment at doses ≥150 mg/kg/day and eye opening and preputial separation associated with reduced bodyweight gain of the offspring at 400 mg/kg/day. In addition, decreased fetal survival and litter loss was observed due to maternal toxicity and poor maternal care, respectively, at doses ≥150 mg/kg/day. No effects were observed at 50 mg/kg/day (which is estimated to be less than the human exposure at the RHD). No effects on number of offspring, proportion of males, number of live pups, or survival to PND 4 were observed at any dose in the offspring born to the second generation. Maribavir is not recommended during pregnancy and in women of childbearing potential not using contraception.
Use in lactation: It is unknown whether maribavir or its metabolites are excreted in human milk. A risk to the suckling child cannot be excluded. Breast feeding should be discontinued during treatment with maribavir.