Pregnancy: There are limited amount of data that indicate no increased risk from the use of Berinert in pregnant women. Berinert is a physiological component of human plasma. Therefore, no studies on reproduction and developmental toxicity have been performed in animals and no adverse effects on fertility, pre- and postnatal development are expected in humans.
Therefore, Berinert should be given to a pregnant woman only if clearly needed.
Breastfeeding: It is unknown whether Berinert is excreted in human milk, but due to its high molecular weight, the transfer of Berinert into breast milk seems unlikely. However, breastfeeding is questionable in women suffering from hereditary angioedema. A decision must be made whether to discontinue breastfeeding or to discontinue the Berinert therapy taking into account the benefit of breastfeeding for the child and the benefit of therapy for the woman.
Fertility: Berinert is a physiological component of human plasma. Therefore, no studies on reproduction and developmental toxicity have been performed in animals and no adverse effects on fertility, pre- and postnatal development are expected in humans.