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Pregnancy: There are no or limited amount of data from the use of burosumab in pregnant women.
Studies in animals have shown reproductive toxicity (see Pharmacology: Toxicology: Preclinical safety data under Actions).
Burosumab is not recommended during pregnancy and in women of childbearing potential not using contraception.
Breast-feeding: It is unknown whether burosumab/metabolites are excreted in human milk.
A risk to newborns/infants cannot be excluded.
A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from burosumab therapy taking into account the benefit of breast feeding for the child and the benefit of therapy for the woman.
Fertility: Studies in animals have shown effects on male reproductive organs (see Pharmacology: Toxicology: Preclinical safety data under Actions). There are no clinical data available on the effect of burosumab on human fertility. No specific fertility studies in animals with burosumab were conducted.
