title: Activated recombinant human coagulation factor VII (rFVIIa) therapy for abdominal bleeding in patients with inhibitory antibodies to factor VIII.
abstract: Eight patients with inhibitors to factor VIII (4 hemophilia A and 4 nonhemophilic) were treated with recombinant activated factor VII (rFVIIa) to control severe abdominal bleeding. The recombinant factor was supplied under an open-label, emergency-use program to patients previously unresponsive to one or more alternative therapies. Therapy with rFVIIa was administered for nine separate bleeding events; one patient was treated for two separate bleeding episodes. Patients were treated for an average of 9 days and received a mean total dose of 5.2 mg of rFVIIa for control of bleeding. Treatment was considered successful and hemostasis adequate in 7 of the 9 episodes (78%). Treatment with rFVIIa was partially successful in one other episode. Four patients in this series experienced serious adverse events; all the adverse events were considered unrelated to rFVIIa therapy. The results of this limited series indicate that rFVIIa is an effective means of managing life-threatening abdominal bleeding in individuals with hemophilia or acquired antibodies to factor VIII.
authors.affiliation: University of Southern California School of Medicine, Division of Hematology, Los Angeles, California 90033, USA. liebman@hsc.usc.edu
authors.forename: H A
authors.initials: HA
authors.lastname: Liebman
authors.forename: J
authors.initials: J
authors.lastname: Chediak
authors.forename: K I
authors.initials: KI
authors.lastname: Fink
authors.forename: A G
authors.initials: AG
authors.lastname: Galvez
authors.forename: P C
authors.initials: PC
authors.lastname: Shah
authors.forename: R L
authors.initials: RL
authors.lastname: Sham
mesh_terms: D000005:Abdomen; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001323:Autoantibodies / Q000097:blood; D002648:Child; D020147:Coagulation Protein Disorders / Q000188:drug therapy* / Q000276:immunology; D004334:Drug Administration Schedule; D005164:Factor IX / Q000276:immunology; D005167:Factor VII / Q000627:therapeutic use*; D005168:Factor VII Deficiency / Q000188:drug therapy; D005169:Factor VIII / Q000276:immunology; D015942:Factor VIIa; D005260:Female; D006467:Hemophilia A / Q000188:drug therapy; D002836:Hemophilia B / Q000188:drug therapy; D006470:Hemorrhage / Q000188:drug therapy / Q000209:etiology* / Q000276:immunology; D006801:Humans; D007275:Injections, Intravenous; D008297:Male; D008875:Middle Aged; D011994:Recombinant Proteins / Q000627:therapeutic use; D016896:Treatment Outcome
chemical_list: D001323:Autoantibodies; D011994:Recombinant Proteins; D005167:Factor VII; D005169:Factor VIII; D005164:Factor IX; C103587:recombinant FVIIa; D015942:Factor VIIa