Pregnancy & Lactation : הריון/הנקה

4.6    Fertility, pregnancy and lactation

Pregnancy

There are no data from the use of glucarpidase in pregnant women. Glucarpidase is administered in combination with MTX, which is contraindicated in pregnancy. As use of MTX, a genotoxic and teratogenic agent, is a prerequisite for the use of glucarpidase, the medicinal product is not thought to present an additional risk to patients already receiving MTX. Reproductive studies of glucarpidase in animals were not performed. It is unknown whether glucarpidase causes harmful effects during pregnancy and/or on the foetus/newborn child or whether it can affect reproductive capacity.
Glucarpidase should only be given to a pregnant woman if clearly needed.

Breast-feeding

It is unknown whether glucarpidase/metabolites are excreted in human milk. A risk to the newborns/infants cannot be excluded. A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from glucarpidase therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.

Fertility

There is no or limited amount of data on the impact of glucarpidase on human fertility. Fertility studies in animals were not performed. It is unknown whether glucarpidase affects fertility.