Transfusion medicine service policies for recombinant factor VIIa administration.
Recombinant FVIIa (rFVIIa) has been approved for treatment of bleeding in hemophilia patients with inhibitors. It has also been successfully used in nonhemophilia patients with acquired antibodies against FVIII (acquired hemophilia). Pharmacological doses of rFVIIa have been found to enhance the thrombin generation on already activated platelets and, therefore, may also likely be of benefit in providing hemostasis in other situations characterized by profuse bleeding and impaired thrombin generation, such as patients with thrombocytopenia and in those with functional platelet defects. Additionally, it has been used successfully in a variety of less well-characterized bleeding situations, as well as in patients with impaired liver function. To date, case reports, anecdotal experience, and limited clinical trials describe these uses; data from randomized clinical trials are limited. Because of the recent trends in rFVIIa usage in non-approved settings among physicians from various disciplines, significant concerns about its safety, efficacy, and costs have arisen. Additionally, dosing of rFVIIa for these potentially broad clinical applications is not standardized. Currently, the decision on when and where to use rFVIIa for patients with uncontrolled bleeding continues to be one that must be made by individual physicians, assisted by their hospital pharmacotherapeutics and transfusion committees.
Goodnough
Lawrence Tim
LT
Department of Medicine, Washington University School of Medicine Barnes-Jewish Hospital, St. Louis, Missouri, USA. goodnough@pathbox.wustl.edu
Lublin
Douglas M
DM
Zhang
Lini
L
Despotis
George
G
Eby
Charles
C
D001771:Blood Banks / Q000592:standards; D016063:Blood Loss, Surgical; D001791:Blood Platelet Disorders / Q000150:complications; D005164:Factor IX / Q000037:antagonists & inhibitors; D005167:Factor VII / Q000008:administration & dosage* / Q000009:adverse effects / Q000494:pharmacology / Q000627:therapeutic use; D005169:Factor VIII / Q000037:antagonists & inhibitors; D015942:Factor VIIa; D006467:Hemophilia A / Q000150:complications; D002836:Hemophilia B / Q000150:complications; D006470:Hemorrhage / Q000188:drug therapy / Q000209:etiology; D006801:Humans; D007518:Isoantibodies / Q000276:immunology; D017410:Practice Guidelines as Topic; D011994:Recombinant Proteins / Q000008:administration & dosage* / Q000009:adverse effects / Q000494:pharmacology / Q000627:therapeutic use; D013917:Thrombin / Q000096:biosynthesis; D014947:Wounds and Injuries / Q000150:complications
D007518:Isoantibodies; D011994:Recombinant Proteins; D005167:Factor VII; D005169:Factor VIII; D005164:Factor IX; C103587:recombinant FVIIa; D015942:Factor VIIa; D013917:Thrombin