Tecfidera Use In Pregnancy & Lactation

Pregnancy: A moderate amount of data on pregnant women are available (between 300-1,000 pregnancy outcomes), based on a pregnancy registry and post-marketing spontaneous reports. In the Tecfidera pregnancy registry, 289 prospectively collected pregnancy outcomes were documented in patients with MS who were exposed to dimethyl fumarate. The median duration of exposure to dimethyl fumarate was 4.6 gestational weeks with limited exposure after the sixth gestational week (44 pregnancy outcomes). Exposure to dimethyl fumarate during such early pregnancy indicates no malformative or foeto/neonatal toxicity compared to the general population. The risk of longer dimethyl fumarate exposure or exposure in later stages of pregnancy is not known.
Animal studies have shown reproductive toxicity (see Pharmacology: Toxicology: Preclinical safety data under Actions). As a precautionary measure, it is preferable to avoid the use of Tecfidera during pregnancy. Tecfidera 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 Tecfidera therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.
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 Pharmacology: Toxicology: Preclinical safety data under Actions).