Perioperative safety and hemostatic efficacy of Advate in patients with hemophilia A in a postmarketing surveillance in Japan.

Rurioctocog alfa (recombinant factor VIII: Advate) is available for the control of bleeding among patients with hemophilia A in Japan. To evaluate the perioperative safety and hemostatic efficacy of Advate, a postmarketing surveillance was conducted in Japanese patients undergoing surgery in a real-world setting. A total of 74 surgical procedures performed in 58 subjects aged 0-75 years, including three females, were studied. A hemostatic efficacy rating of "excellent" or "good" was reported in 73/74 surgical procedures (98.6%). Perioperative bleeding was successfully controlled by Advate in five subjects with positive FVIII inhibitors (2.4-9.1 BU/mL). Advate was administered at higher initial bolus doses (114-385 IU/kg) and at higher rates by subsequent initial continuous infusion (8.3-15 IU/kg/hour) in the five subjects with inhibitor than in the subjects without inhibitor (n = 47; mean initial bolus dose: 53.4 IU/kg; subsequent mean initial continuous infusion: 3.8 IU/kg/h). Adverse drug reactions were reported in 7/74 (9.5%) procedures, two of which were the development of de novo FVIII inhibitors. Overall, the perioperative use of Advate in a real-world setting was found to be safe and effective among Japanese patients with hemophilia A.