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Pregnancy: There are no or limited amount of data (less than 300 pregnancy outcomes) from the use of epoetin theta in pregnant women. Animal studies with other epoetins do not indicate direct harmful effects with respect to reproductive toxicity (see Pharmacology: Toxicology: Preclinical safety data under Actions). As a precautionary measure, it is preferable to avoid the use of Eporatio during pregnancy.
Breast-feeding: It is unknown whether epoetin theta/metabolites are excreted in human milk, but data in neonates show no absorption or pharmacological activity of erythropoietin when given together with breast milk. A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from Eporatio therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.
Fertility: No data are available.
