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Pregnancy: There are no or limited data from the use of baloxavir marboxil in pregnant women.
Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity (see Pharmacology: Toxicology: Preclinical safety data under Actions).
As a precautionary measure, it is preferable to avoid the use of Xofluza during pregnancy.
Breast-feeding: It is unknown whether baloxavir marboxil or baloxavir are excreted in human milk. Baloxavir marboxil and its metabolites are secreted in the milk of lactating rats.
A risk to the newborns/infants cannot be excluded.
A decision must be made whether to discontinue breast-feeding or to abstain from baloxavir marboxil therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.
Fertility: No effects on male or female fertility were observed in animal studies performed with baloxavir marboxil (see Pharmacology: Toxicology: Preclinical safety data under Actions).
