Safety and Efficacy of Activated Recombinant FVII in Uncontrolled Bleeding Episodes.

Activated recombinant FVII (rFVIIa, NovoSeven) has been successfully used to control bleeding episodes in a variety of medical and surgical conditions including bleeding episodes secondary to over-anticoagulation, trauma, intracerebral hemorrhage, post operative bleeding and other refractory bleeding disorders. We report our experience in the use of rFVIIa to control bleeding episodes after failure of conventional measures.

A total of 5 patients (Behcet’s disease 1, over-anticoagulation with warfain and asprin 2, tuberculosis 1, and acute lymphoblastic leukaemia 1) were included in this analysis. The median age of the patients is 41. The bleeding episodes included massive hemoptysis 1, subdural hematoma 2, hemothorax and injury to intercostal artery following pleural biopsy 1 and cytomegalovirus-induced gastroenteritis in 1 patient. All patients failed to respond to conventional therapies prior to rFVIIa. The bleedings stopped with an average dose of 75 mcg/kg and with the average number of 2 doses of rFVIIa. No safety issues were encountered.

Conclusion: The use of rFVIIa is effective in the control of refractory bleeding episodes in patients with a variety of underlying medical or surgical conditions. In this small experience, a dose similar to that approved for patients with hemophilia and inhibitors appears to be effective to control bleeding within a short period of time after administration of rFVIIa. No safety issues were encountered in this group of patients. Further studies to evaluate the utility and appropriate dose and frequency of rFVIIa in refractory bleeding disorders are warranted.