International Journal of Hematology

, Volume 95, Issue 1, pp 57–63

Recombinant activated factor VII (rFVIIa/NovoSeven®) in the management of severe postpartum haemorrhage: initial report of a multicentre case series in Japan

  • Takao Kobayashi
  • Masao Nakabayashi
  • Akira Yoshioka
  • Makoto Maeda
  • Tsuyomu Ikenoue
Original Article

DOI: 10.1007/s12185-011-0974-9

Cite this article as:
Kobayashi, T., Nakabayashi, M., Yoshioka, A. et al. Int J Hematol (2012) 95: 57. doi:10.1007/s12185-011-0974-9


Only a limited number of case reports documenting the off-label use of recombinant factor VIIa (rFVIIa) in Japanese patients with postpartum haemorrhage (PPH) have been published. Data on Japanese cases with severe PPH in which rFVIIa was administered were collected. Data of obstetric haemorrhage patients treated with rFVIIa between 2005 and 2010 were retrospectively collected throughout Japan. The data included patients’ background information, blood product requirements, dose/timing of rFVIIa, and adverse effects. Treating clinicians subjectively assessed the effect of rFVIIa on bleeding at each administration using four categories: “Stopped”, “Decreased”, “Unchanged”, and “Increased”. A total of 25 women received rFVIIa for the treatment of obstetric haemorrhage in 18 institutions. After the final administration, bleeding was “stopped” in 16 patients (64%), “decreased” in eight patients (32%), and “unchanged” in one patient (4%). A significant reduction in blood product requirement was observed following the first rFVIIa administration. Hysterectomy was required in two patients (15.4%) after rFVIIa administration. Four asymptomatic thrombotic events were reported in three patients. These results suggest that rFVIIa can be a beneficial therapeutic option that can reduce blood loss and prevent hysterectomy in Japanese patients with massive obstetric bleeding.


HysterectomyPostpartum haemorrhageRecombinant activated factor VII

Copyright information

© The Japanese Society of Hematology 2011

Authors and Affiliations

  • Takao Kobayashi
    • 1
  • Masao Nakabayashi
    • 2
  • Akira Yoshioka
    • 3
  • Makoto Maeda
    • 4
  • Tsuyomu Ikenoue
    • 5
  1. 1.Hamamatsu Medical CenterHamamatsuJapan
  2. 2.Aiiku Maternal and Child Health CenterTokyoJapan
  3. 3.Nara Medical UniversityKashiharaJapan
  4. 4.Department of Obstetrics and GynecologyMie Chuo Medical CenterTsuJapan
  5. 5.University of Miyazaki HospitalMiyazakiJapan