Recombinant Factor VIIa [rFVIIa - NovoSeven®] for Diffuse Intractable Bleedings

Recombinant factor VIIa as an adjunctive therapy for patients requiring large volume transfusion: a pharmacoeconomic evaluation

“…Clinical evidence to support rFVIIa use to control haemorrhage in the non‐haemophilia population is limited largely to case reports 11–19 . These reports reflect current off‐label practice of using this product as a last resort when usual techniques to control bleeding have failed.…”

“…This model was based on several key assumptions about rFVIIa dose and effect. Published case reports on use of rFVIIa for critical haemorrhage describe doses ranging from 30 µg/kg to 210 µg/kg 11–19 . We hypothesized a dose of 100 µg/kg (the dose used in current trauma studies) and assumed an average weight of 70 kg, giving a single rFVIIa dose of 7.2 mg, for which a cost of $NZ8467.89 (GST incl.)…”

“…was assigned according to current retail drug cost in New Zealand. Our first key assumption was that a single rFVIIa dose would control bleeding, based on published reports of a single dose effect for trauma‐associated bleeding 11–19 . According to this assumption, at whatever time point in the transfusion episode rFVIIa was used, bleeding would stop and no further blood products would be required.…”