Relevance of a single dose of 270 μg/kg recombinant factor VIIa for the treatment of patients with haemophilia and inhibitors

Summary

Recombinant activated factor VII (rFVIIa; Novo Seven^®) is, besides other indications, authorised for the treatment of bleeding episodes in patients with hereditary haemophilia A or B and inhibitors. Based on the results of three clinical studies, marketing authorisation was granted for the single dose of 270 μg/kg body weight rFVIIa for the treatment of mild-to-moderate bleeding episodes in patients with haemophilia A or B with inhibitors in March 2007. Thereupon, an expert group analysed the relevance of this additional treatment option for clinical routine. Compared with the repeated application of 90 μg/kg body weight rFVIIa, quality of life may be improved if the single dose of 270 μg/kg body weight rFVIIa reduces the number of injections. The single dose has a benefit for those patients who require several rFVIIa applications or who do not respond adequately to low doses. Moreover, patients with poor venous access or who fear injections or reject them (especially children) may benefit from the single dose. The prescription of 270 μg/kg body weight rFVIIa as a single dose instead of multiple dosing of 90 μg/kg body weight is basically an individual and indication-related decision.

Keywords

Recombinant factor VIIa - single dose - haemophilia - inhibitors

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