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

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 pa...

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Bibliographic Details
Published in:International journal of hematology 2012, Vol.95 (1), p.57-63
Main Authors: Kobayashi, Takao, Nakabayashi, Masao, Yoshioka, Akira, Maeda, Makoto, Ikenoue, Tsuyomu
Format: Article
Language:English
Subjects:
Adult
Biological and medical sciences
Coagulants - therapeutic use
Factor VIIa - therapeutic use
Female
Hematologic and hematopoietic diseases
Hematology
Humans
Japan
Medical sciences
Medicine
Medicine & Public Health
Off-Label Use
Oncology
Original Article
Postpartum Hemorrhage - drug therapy
Postpartum Hemorrhage - physiopathology
Pregnancy
Recombinant Proteins - therapeutic use
Retrospective Studies
Severity of Illness Index
Young Adult
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Summary: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.
ISSN:0925-5710
1865-3774
DOI:10.1007/s12185-011-0974-9