Efficacy and safety of recombinant factor VIIa preparation (NovoSeven) for patients with congenital factor VII deficiency

DOI 6 Citations 62 References
  • HANABUSA Hideji
    Department of Hematology, Department of Pediatrics, Ogikubo Hospital
  • OYAMA Kazushige
    Department of Pediatrics, Hachinohe Red Cross Hospital
  • WATANABE Satoshi
    Department of Surgery, Fujita General Hospital
  • SAKAKIBARA Yuzuru
    Department of Cardiovascular Surgery, Institute of Clinical Medicine, University of Tsukuba
  • HIRAMATSU Yuji
    Department of Cardiovascular Surgery, Institute of Clinical Medicine, University of Tsukuba
  • SHIMPUKU Genji
    Department of Emergency Care Unit, Yokohama City University Hospital
  • TAKAGI Hiroyuki
    Department of Surgery, Hata General Hospital
  • SATO Koji
    Section of Oral Surgery, Dental Department, Fujita Health University
  • SAKABE Hideaki
    Department of Internal Medicine, Kohka Public Hospital
  • NAKATANI Hiroshi
    Department of Urology, Coop Osaka Hospital
  • HIGASA Satoshi
    Department of Hematology, Hyogo College of Medicine
  • SAWADA Akihiro
    Department of Hematology, Hyogo College of Medicine
  • NISHIKAWA Tetsuo
    Department of Orthopaedic Surgery, Kobe University Graduate School of Medicine, Nishikawa Orthopaedics & Rehabilitation Clinic
  • ITO Keijiro
    Department of Obstetrics and Gynecology , National Hospital Organization Hiroshima-Nishi Medical Center
  • TAKAMIYA Osamu
    Laboratory of Hematology, Department of Biomedical Laboratory Sciences, School of Health Sciences, Shinshu University
  • YOSHIOKA Akira
    Department of Pediatrics, Nara Medical University

Bibliographic Information

Other Title
  • 先天性第ＶＩＩ因子欠乏症患者に対する遺伝子組換え活性型第ＶＩＩ因子製剤（注射用ノボセブン）の有効性と安全性

Search this article

Abstract

The efficacy and the safety of a recombinant activated factor VII preparation (rFVIIa, NovoSeven®) were retrospectively analyzed in 13 patients with congenital factor VII(FVII) deficiency including 6 males and 7 females. Their age ranged from 60 days after birth to 78 years, and their plasma FVIIc levels were <3% in 7, 3-10% in 2 and > 10 in 4 patients. The bleeding episodes included hypermenorrhea in 2, joint bleeding in 3, bleeding related to minor surgery in 2 and major surgery in 6 patients. The rFVIIa was administered at an initial dose of 10-35 μg/kg of body weight and this dose was further added at every 2-8 hours as required to achieve efficient hemostasis. The rFVIIa preparation was found to be effective for the control of bleedings in all these patients, and no severe adverse events including thromboembolic complications were recorded except abnormal laboratory findings noted in a single patient. In Europe and USA, the dose of 15-30 μg/kg of body weight has been recommended for the control of bleeding in patients with FVII deficiency, and this recommendation seems to be legitimate based on our analysis data. The efficacy and the safety of this rFVIIa preparation were confirmed in this study as well.

Journal

Citations (6)*help

See more

References(62)*help

See more

Keywords

Details 詳細情報について

Report a problem

Back to top