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

Abstract

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.

Evaluation and management of postpartum hemorrhage: consensus from an international expert panel

“…The off‐label use of rFVIIa, which was originally developed for the treatment of hemophilia, has been reported for the management of PPH . Existing data are retrospective but cessation of bleeding is reported in some women with major hemorrhage . The Australian and New Zealand Haemostasis Registry reported improvement (cessation or significant slowing) in bleeding in 76% of women (n = 71/94) who were administered rFVIIa (median dose, 92 μg/kg) for the treatment of acute PPH and a Northern European registry reported improvements in 80% of women with major PPH (n = 92).…”

Successful management of maternal factor VII deficiency in a cesarean section

“…In postpartum hemorrhage, common non-operative management involves the use of uterine stimulants, bimanual compression of the uterus and uterine artery embolization [12]. More recently, rFVIIa has also been used to prevent or control bleeding in postpartum hemorrhage [13]. However, it has thrombotic risks, and there are no definitive target FVII levels or optimal treatment regimens to maintain hemostasis [14].…”

Recombinant human FVIIa for reducing the need for invasive second‐line therapies in severe refractory postpartum hemorrhage: a multicenter, randomized, open controlled trial

“…After the formal beginning of this randomized controlled trial (RCT), Welsh et al and Phillips et al published, based on their experience and on the published cases series, guidelines and an algorithm for the use of rhuFVIIa at 90 lg kg À1 in patients with PPH after surgical intervention (arterial embolization, arterial ligatures and peripartum hysterectomy) [18,19]. A recent systematic review of 272 patients suggested that rhuFVIIa might be useful for the management of severe refractory PPH compared with standard treatment [20,21].…”