Pregnancy: Animal reproduction studies have not been conducted with XYNTHA. Based on the rare occurrence of hemophilia A in women, experience regarding the use of factor VIII during pregnancy is not available. Therefore, XYNTHA should be administered to pregnant women only if clearly indicated.
Lactation: Animal reproduction studies have not been conducted with XYNTHA. It is not known whether this drug is excreted into human milk. Based on the rare occurrence of hemophilia A in women, experience regarding the use of factor VIII products during breastfeeding is not available. Therefore, XYNTHA should be administered to lactating women only if clearly indicated.