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Pregnancy: There are no or limited amount of data from the use of filgrastim in pregnant women. Studies in animals have shown reproductive toxicity. An increased incidence of embryo-loss has been observed in rabbits at high multiples of the clinical exposure and in the presence of maternal toxicity. There are reports in the literature where the transplacental passage of filgrastim in pregnant women has been demonstrated.
Neupogen is not recommended during pregnancy.
Breast-feeding: It is unknown whether filgrastim/metabolites are excreted in human milk. A risk to the newborns/infants cannot be excluded. A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from Neupogen therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.
Fertility: Filgrastim did not affect reproductive performance or fertility in male or female rats.
