International Journal of Hematology

DOI: 10.1007/s12185-018-2434-2 Pages: 22-29

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

1. Nara Medical University, Department of Pediatrics

2. The University of Tokyo, Department of Joint Surgery, The Institute of Medical Science

3. Nagoya University Hospital, Department of Transfusion Medicine

4. Japanese Red Cross Tokai-Hokuriku Block Blood Center

5. St. Marianna University School of Medicine Yokohama City Seibu Hospital, Department of Pediatrics

6. Tokyo Medical University Hospital, Department of Laboratory Medicine

7. Shire Japan K.K., Department of Clinical Scientific Writing, Clinical Development Operations

8. Shire Japan K.K., Department of Medical Affairs

9. Baxalta Innovations GmbH, Department of Biostatistics

10. Kitakyushu Yahata Higashi Hospital

Correspondence to:
Keiji Nogami
Email: roc-noga@naramed-u.ac.jp

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Abstract

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.

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