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Pregnancy: There are no or limited amount of data from the use of pegfilgrastim in pregnant women. Studies in animals have shown reproductive toxicity (see Pharmacology: Toxicology: Preclinical safety data under Actions). Neulastim is not recommended during pregnancy and in women of childbearing potential not using contraception.
Breast-feeding: There is insufficient information on the excretion of Neulastim/metabolites 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 Neulastim therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.
Fertility: Pegfilgrastim did not affect reproductive performance or fertility in male or female rats at cumulative weekly doses approximately 6 to 9 times higher than the recommended human dose (based on body surface area) (see Pharmacology: Toxicology: Preclinical safety data under Actions).
