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Pregnancy: There are no or limited amount of data from the use of nusinersen in pregnant women. Animal studies do not indicate direct or indirect 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 nusinersen during pregnancy.
Breast-feeding: It is unknown whether nusinersen/metabolites are excreted in human milk.
A risk to the newborn/infants cannot be excluded. A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from nusinersen therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.
Fertility: In toxicity studies in animals no effects on male or female fertility were observed (see Pharmacology: Toxicology: Preclinical safety data under Actions). There are no data available on the potential effects on fertility in humans.
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