Pregnancy: The safety of FIBRYGA for use in human pregnancy has not been established in controlled clinical trials. Clinical experience with fibrinogen products in the treatment of obstetric complications suggests that no harmful effects on the course of the pregnancy or health of the fetus or the neonate are to be expected.
Animal reproduction studies have not been conducted with FIBRYGA (see Pharmacology: Toxicology: Preclinical safety data under Actions). Since the active substance is of human origin, it is catabolised in the same manner as the patient's own protein. These physiological constituents of the human blood are not expected to induce adverse effects on reproduction or on the fetus.
The benefit of FIBRYGA during pregnancy must be evaluated taking into consideration that clinical experience with fibrinogen concentrates is available but data from controlled clinical trials are missing.
Breastfeeding: It is unknown whether FIBRYGA is excreted in human milk. However, because of the nature of the substance, no effects on the breastfed newborn/infant are anticipated.
Thus, a decision must be made whether FIBRYGA therapy is indicated during breast-feeding 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 fertility available.