Pregnancy: There are no data from the use of MOLNUPAC 200/MOLNUPAC 400 in pregnant women. Studies in animals have shown reproductive toxicity. MOLNUPAC 200/MOLNUPAC 400 is not recommended during pregnancy. Women of childbearing potential should use effective contraception for the duration of treatment and for 4 days after the last dose of MOLNUPAC 200/MOLNUPAC 400 (molnupiravir).
Breast-feeding: It is unknown whether molnupiravir or any of the components of molnupiravir are present in human milk, affect human milk production, or have effect on the breastfed infant. Animal lactation studies with molnupiravir have not been conducted.
Based on the potential for adverse reactions on the infant from MOLNUPAC 200/MOLNUPAC 400, breast-feeding is not recommended during treatment and for 4 days after the last dose of MOLNUPAC 200/MOLNUPAC 400.
Fertility: There were no effects on female or male fertility in rats at NHC exposures approximately 2 and 6 times respectively, the exposure in humans at the recommended human dose (RHD).