Safety update on the use of recombinant activated factor VII in approved indications

This updated safety review summarises the large body of safety data available on the use of recombinant activated factor VII (rFVIIa) in approved indications: haemophilia with inhibitors, congenital factor VII (FVII) deficiency, acquired haemophilia and Glanzmann's thrombasthenia. Accumulated data up to 31 December 2013 from clinical trials as well as post-marketing data (registries, literature reports and spontaneous reports) were included. Overall, rFVIIa has shown a consistently favourable safety profile, with no unexpected safety concerns, in all approved indications.

Source: Blood Reviews - June 1, 2015 Category: Hematology Authors: Ellis J Neufeld, Claude Négrier, Per Arkhammar, Soraya Benchikh el Fegoun, Mette Duelund Simonsen, Anders Rosholm, Stephanie Seremetis Source Type: research