Pregnancy: There are no adequate and well-controlled studies in pregnant women.
Studies in animals have shown reproduction toxicology (see Pharmacology: Toxicology: Preclinical safety data under Actions).
In chronic renal failure patients, epoetin alfa should be used in pregnancy only if the potential benefit outweighs the potential risk to the foetus.
In pregnant or lactating surgical patients participating in an autologous blood predonation programme, the use of epoetin alfa is not recommended.
Breast-feeding: It is not known whether exogenous epoetin alfa is excreted in human milk. Epoetin alfa should be used with caution in nursing women.
A decision on whether to continue/discontinue breast-feeding or to continue/discontinue therapy with epoetin alfa should be made taking into account the benefit of breast-feeding to the child and the benefit of epoetin alfa therapy to the woman.