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

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.