Ten‐year experience of recombinant activated factor VII use in surgical patients with congenital haemophilia with inhibitors or acquired haemophilia in Japan

Ten-year experience of recombinant activated factor VII use in surgical patients with congenital haemophilia with inhibitors or acquired haemophilia in Japan - Takedani - 2014 - Haemophilia - Wiley Online Library Skip to Main Content Log in / Register Log In E-Mail Address Password Forgotten Password?

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You have full text access to this OnlineOpen articleTen-year experience of recombinant activated factor VII use in surgical patients with congenital haemophilia with inhibitors or acquired haemophilia in JapanH. Takedani1, M. Shima2,*, Y. Horikoshi3, T. Koyama4, K. Fukutake5, M. Kuwahara6 andN. Ishiguro7Article first published online: 18 DEC 2014

DOI: 10.1111/hae.12611

© 2014 The Authors. Haemophilia Published by John Wiley & Sons Ltd.

This is an open access article under the terms of the Creative Commons Attribution-NonCommercial License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited and is not used for commercial purposes.

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HaemophiliaEarly View (Online Version of Record published before inclusion in an issue)

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How to CiteTakedani, H., Shima, M., Horikoshi, Y., Koyama, T., Fukutake, K., Kuwahara, M. and Ishiguro, N. (2014), Ten-year experience of recombinant activated factor VII use in surgical patients with congenital haemophilia with inhibitors or acquired haemophilia in Japan. Haemophilia. doi: 10.1111/hae.12611

Author Information1

Hospital of the Institute of Medical Science of the University of Tokyo (IMSUT), Tokyo, Japan

2

Nara Medical University, Kashihara, Japan

3

Shizuoka Children's Hospital, Shizuoka, Japan

4

Tokyo Medical and Dental University, Tokyo, Japan

5

Tokyo Medical University, Tokyo, Japan

6

Novo Nordisk Pharma Ltd., Tokyo, Japan

7

Nagoya University School of Medicine, Nagoya, Japan

* Correspondence: Midori Shima, Nara Medical University, 840 Shijo-cho, Kashihara, Nara 634-8522, Japan.
Tel.: 0744 22 3051; fax: 0744 24 9222;
e-mail: mshima@naramed-u.ac.jp

Publication HistoryArticle first published online: 18 DEC 2014Manuscript Accepted: 10 NOV 2014Funded byNovo Nordisk Pharma Ltd SEARCH Search Scope All contentPublication titlesIn this journalIn this issue Search String Advanced >Saved Searches > SEARCH BY CITATION Volume: Issue: Page: ARTICLE TOOLSGet PDF (107K)Save to My ProfileE-mail Link to this ArticleExport Citation for this ArticleGet Citation AlertsRequest Permissions AbstractArticleReferencesSupporting InformationCited By View Full Article with Supporting Information (HTML) Enhanced Article (HTML) Get PDF (107K) Keywords:continuous infusion;haemophilia with inhibitors;Japan;postmarketing surveillance;recombinant factor VIIa;surgerySummary

Patients with congenital haemophilia with inhibitors or acquired haemophilia are at risk of bleeding complications during surgery. In these patients, replacement therapy for the missing coagulation factor is ineffective, and a bypassing agent such as recombinant activated factor VII (rFVIIa) is required to manage bleeding. To evaluate the safety and haemostatic efficacy of rFVIIa treatment in Japanese patients with congenital haemophilia with inhibitors to FVIII/FIX or acquired haemophilia undergoing surgery. Postmarketing surveillance data from May 2000 to March 2010 were analysed to assess the haemostatic efficacy of 38 procedures in 22 patients with congenital haemophilia A, 13 procedures in seven patients with congenital haemophilia B, and five procedures in five patients with acquired haemophilia. Postoperative bleeding control was judged to be effective (bleeding was stopped completely or reduced considerably) for 34/38 procedures (89%) in patients with congenital haemophilia A, 10/13 procedures (77%) in patients with congenital haemophilia B, and 4/5 procedures (80%) in patients with acquired haemophilia. Tranexamic acid was used concomitantly for 36/56 procedures (64%). Safety was analysed for 66 procedures in 37 patients. Adverse effects potentially related to rFVIIa treatment included mild superficial thrombophlebitis, mild decrease in platelet count, and mild elevation of the serum alanine transaminase level in one patient each. All adverse effects resolved without treatment. Administration of rFVIIa provided adequate haemostasis without serious adverse effects in the majority of cases. The efficacy and safety data in Japanese patients were similar to previously published data from other countries.

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