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Pregnant Women: Remdesivir should only be administered to pregnant women or women who may possibly be pregnant if the therapeutic benefits outweigh the risks. In studies of effects on embryo-fetal development in pregnant rats and rabbits, IV administration of remdesivir up to 20 mg/kg (the systemic exposure (AUC) to a major circulating metabolite (nucleoside analogue) corresponding to 4-fold exposure level at the approved dose) did not affect embryo-fetal development. In a study of the effect on fertility and early embryonic development in female rats, a decrease in corpora lutea, embryonic implantations, and viable embryos was observed following intravenously administration of remdesivir 10 mg/kg (the systemic exposure (AUC) of the major circulating metabolite (nucleoside analogue) was correspond to 1.3-fold exposure level at the approved dose).
Breast-feeding Women: Lactation should be continued or discontinued in consideration of therapeutic benefits and benefits of maternal nursing. In animal studies (rat), remdesivir and its metabolites have been detected in the nursing pups of mothers given remdesivir, likely due to the presence of remdesivir into breast milk.
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