Pregnancy & Lactation : הריון/הנקה

4.6    Fertility, pregnancy and lactation

Pregnancy
There are no or limited amount of data from the use of Dimethyl fumarate in pregnant women. Animal studies have shown reproductive toxicity (see section 5.3). Dimethyl fumarate is not recommended during pregnancy and in women of childbearing potential not using appropriate contraception (see section 4.5). Dimethyl fumarate should be used during pregnancy only if clearly needed and if the potential benefit justifies the potential risk to the foetus.

Breast-feeding

It is unknown whether Dimethyl fumarate or its 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 Dimethyl fumarate therapy. The benefit of breast-feeding for the child and the benefit of therapy for the woman should be taken into account.

Fertility

There are no data on the effects of Dimethyl fumarate on human fertility. Data from preclinical studies do not suggest that Dimethyl fumarate would be associated with an increased risk of reduced fertility (see section 5.3).