Arkin S. Blei F. Fetten J. Foulke R. Gilchrist GS. Heisel MA. Key N. Kisker CT. Kitchen C. Shafer FE. Shah PC. Strickland D., Human coagulation factor FVIIa (recombinant) in the management of limb-threatening bleeds unresponsive to alternative therapies: results from the NovoSeven emergency-use program in patients with severe hemophilia or with acquired inhibitors. Blood Coagulation & Fibrinolysis. 11(3):255-9, 2000.
This open-label, emergency-use study evaluated the efficacy and safety of activated human coagulation factor VIIa (recombinant) (rFVIIa) (NovoSeven; Novo Nordisk Pharmaceuticals, Inc) in treating limb-threatening joint or muscle bleeds in 17 patients with hemophilia A or B and six patients with acquired inhibitors to factor VIII or factor IX. All patients had previously failed on one or more alternative therapies. rFVIIa administration was effective or partially effective in controlling joint or muscle bleeds in 34 out of 35 (97%) bleeding episodes; in 23 patients, 14 of 17 (82%) muscle bleeds and 16 of 18 (89%) joint bleeds were effectively controlled. These findings suggest that rFVIIa is an effective and well-tolerated therapeutic option in the management of joint or muscle hemorrhage in patients with hemophilia and in patients with acquired inhibitors.