Experience with the “Off Label” Use of Recombinant Factor VIIa in a University Hospital.

Abstract

Recombinant factor VIIa (rFVIIa), NovoSeven@ (Denmark), is a bypass agent approved in the United States for patients with hemophilia and inhibitors. The off-label use of this medication (non approved use) is becoming common in large institutions. Its main use seems to be for excessive bleeding due to trauma and surgery. Here we report our 2 year experience with the off-label use of this product and describe a protocol that is followed at our teaching hospital. Administration of rFVIIa was based on the described protocol. The medication is controlled by the hospital pharmacy and authorization for its use has to be given by the hematologists in collaboration with the clinical pharmacist. To be eligible for the use of rFVIIa the patient has to have received at least 10 units of red pack cells and fresh frozen plasma. In addition, the patient should have fibrinogen level greater than 100 mg/dl, platelet count greater than 70,000/mm3 and fibrin split products less than 80 mcg/ml. A total of 25 patients where treated off-label for excessive bleeding and 4 patients where given rFVIIa preoperative for prevention of bleeding. The doses ranged from 35 to 120 micrograms/kg of body weight with an average of 2 doses given per patient. The use of Factor VIIa was more common in the neurosurgical (NS) setting (7), followed by cardiovascular (CV) (6), gastrointestinal (GI) surgery (6), trauma (6) and others (4). Overall 62% of the patients had adequate hemostasis after the administration of rFVIIa. Successful hemostasis with rFVIIa by diagnosis was 100% for preoperative prophylaxis and GI, for NS 57%, for trauma 50% and for CV 17%. All the patients in the CV group where admitted with acute dissecting aortic aneurysms. No evidence of thromboembolic events where described. The “off-label” use of rFVIIa continues to be widely used with variable results. Until further randomized or controlled, double blind, clinical trials are done, no definitive recommendations can be given. Although this report includes a small cohort of patients, we will consider revising our protocol for bleeding following cardiovascular surgery and trauma.