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 (see Toxicology: Preclinical Safety Data under Actions).
There are reports in the literature where the transplacental passage of filgrastim in pregnant women has been demonstrated.
Filgrastim 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 filgrastim 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 (see Toxicology: Preclinical Safety Data under Actions).