This article describes an analysis of the long-term safety and efficacy of recombinant activated factor VII (rFVIIa) over a 10-year period. From the data of 1,718 bleeding episodes in 142 congenital hemophilia patients with inhibitors, 65% showed improved clinical symptoms within 12 hours after rFVIIa injection. Overall, 88% of bleeding episodes improved following treatment with rFVIIa. Median treatment was dosing period of 1.0 day with 3.0 injections of 103 μg/kg rFVIIa in the patient group without concomitant use of other hemostatic agents. Joint bleeds were most common (63%), followed by muscle bleeds (14%) and subcutaneous hemorrhages (9%). The dosing period was significantly longer for intracranial hemorrhage and gastrointestinal bleeds, and hematuria. Out of 8,097 bleeding episodes and a total of 24,778 injections in 144 patients, 5 thromboembolic events were reported in 4 patients.
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