Perioperative safety and hemostatic efficacy of Advate® in patients with hemophilia A in a postmarketing surveillance in Japan.
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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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| Authors | Keiji Nogami, Hideyuki Takedani, Midori Shima, Akira Yoshioka, Tadashi Matsushita, Junki Takamatsu, Masashi Taki, Katsuyuki Fukutake, Haruhiko Uchikawa, Hiroshi Takagi, Morio Arai, Werner Engl, Akira Shirahata |
| Journal | International journal of hematology (Int J Hematol) Vol. 108 Issue 1 Pg. 22-29 (Jul 2018) ISSN: 1865-3774 [Electronic] Japan |
| PMID | 29594923 (Publication Type: Clinical Trial, Journal Article, Multicenter Study) |
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