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


Ontology type: schema:ScholarlyArticle     


Article Info

DATE

2018-03-28

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

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. More... »

PAGES

22-29

Identifiers

URI

http://scigraph.springernature.com/pub.10.1007/s12185-018-2434-2

DOI

http://dx.doi.org/10.1007/s12185-018-2434-2

DIMENSIONS

https://app.dimensions.ai/details/publication/pub.1101824501

PUBMED

https://www.ncbi.nlm.nih.gov/pubmed/29594923


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