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Pregnancy: There are no or limited amount of data from the use of romiplostim in pregnant women.
Studies in animals have shown that romiplostim crossed the placenta and increased foetal platelet counts. Post implantation loss and a slight increase in peri-natal pup mortality also occurred in animal studies (see Pharmacology: Toxicology: Preclinical safety data under Actions).
Romiplostim is not recommended during pregnancy and in women of childbearing potential not using contraception.
Breast-feeding: It is unknown whether romiplostim/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 romiplostim therapy taking into account the benefit of breast feeding for the child and the benefit of therapy for the woman.
Fertility: There is no data available on fertility.
