Pregnancy & Lactation : הריון/הנקה

4.6    Fertility, pregnancy and lactation

Women of childbearing potential
Women of childbearing potential are advised to use effective contraception during treatment and for 14 days after the last dose if Xenpozyme is discontinued.

Pregnancy

There are no data from the use of olipudase alfa in pregnant women. Studies in animals have shown reproductive toxicity (see section 5.3). Xenpozyme is not recommended during pregnancy and in women of childbearing potential not using effective contraception, unless the potential benefits to the mother outweigh the potential risks, including those to the foetus.

Breast-feeding

It is unknown whether olipudase alfa is excreted in human milk. Olipudase alfa was detected in the milk of lactating mice (see section 5.3). A risk to the newborns/infants cannot be excluded. A decision must be made whether to discontinue breast-feeding or to discontinue Xenpozyme therapy taking into account the benefit of breast feeding for the child and the benefit of therapy for the woman.

Fertility

No human data are available on the effects of olipudase alfa on male and female fertility. Animal data do not indicate direct or indirect harmful effects with respect to fertility (see section 5.3).