Enspryng Use In Pregnancy & Lactation

Fertility: No clinical data are available on the effect of Enspryng on human fertility. Animal studies showed no impairment of male or female fertility (see Toxicology: Preclinical safety data: Impairment of Fertility under Actions).
Pregnancy: There are no data from the use of Enspryng in pregnant women.
Studies in monkeys do not indicate harmful effects with respect to reproductive toxicity (see Toxicology: Preclinical safety data: Reproductive Toxicity under Actions).
Enspryng is not recommended during pregnancy unless the potential benefit for the mother outweighs the potential risk to the fetus.
Lactation: It is unknown whether Enspryng is excreted in human breast milk or absorbed systemically after ingestion. However, because IgGs are excreted in human milk and there is preclinical evidence of excretion in milk (see Toxicology: Preclinical safety data: Reproductive Toxicity under Actions), a decision should be made whether to discontinue breastfeeding or to discontinue Enspryng therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the mother.