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Pregnancy: There are no data from the use of letermovir in pregnant women. Studies in animals have shown reproductive toxicity (see Pharmacology: Toxicology: Preclinical safety data under Actions).
PREVYMIS is not recommended during pregnancy and in women of childbearing potential not using contraception.
Breast-feeding: It is unknown whether letermovir is excreted in human milk.
Available pharmacodynamic/toxicological data in animals have shown excretion of letermovir in milk (see Pharmacology: Toxicology: Preclinical safety data under Actions).
A risk to the newborns/infants cannot be excluded.
A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from PREVYMIS therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.
Fertility: There were no effects on female fertility in rats. Irreversible testicular toxicity and impairment of fertility was observed in male rats, but not in male mice or male monkeys.
