Recombinant factor VIIa: safety and efficacy.
OBJECTIVE
Recombinant factor VIIa has been increasingly used to provide hemostasis in nonapproved indications. This trend has resulted in concerns about safety, efficacy and costs.


RESULTS
Recombinant factor VIIa seems to have hemostatic effects in posttrauma and perisurgery excessive bleeding, although further studies are required. Recombinant factor VIIa may be used to reverse the effect of warfarin or other vitamin K-antagonist therapy following vitamin K administration. Some beneficial effects have also been suggested in a limited number of patients with liver disease and hemorrhagic stroke. Recombinant factor VIIa should be used with caution in cases with known hypercoagulability, excessive bleeding in the setting of disseminated intravascular coagulation or other states of generalized activation of the hemostatic system. In most of the nonapproved cases, a 4.8-mg vial administered to an adult patient weighing 50-100 kg to achieve a 50-100 microg/kg dose is recommended.


CONCLUSIONS
While consensus recommendations on the use of recombinant factor VIIa in nonapproved settings have been developed, more studies are needed to define dose and timing in these diverse patient populations. For now, decisions about off-label use of recombinant factor VIIa remain at the physician's discretion, assisted by hospital pharmacotherapeutic or transfusion committees.
Goodnough
Lawrence T
LT
Department of Pathology and Medicine, Stanford University, Stanford, California 94305-5626, USA. LTgoodno@stanford.edu
Shander
Aryeh S
AS
D000328:Adult; D032921:Consensus; D004211:Disseminated Intravascular Coagulation / Q000139:chemically induced; D004336:Drug Antagonism; D064420:Drug-Related Side Effects and Adverse Reactions; D015942:Factor VIIa / Q000008:administration & dosage* / Q000009:adverse effects* / Q000037:antagonists & inhibitors; D006487:Hemostasis / Q000187:drug effects; D006761:Hospitals; D006801:Humans; D010606:Pharmacy and Therapeutics Committee; D011994:Recombinant Proteins / Q000008:administration & dosage / Q000009:adverse effects / Q000037:antagonists & inhibitors; D020521:Stroke / Q000188:drug therapy*; D014812:Vitamin K / Q000008:administration & dosage / Q000037:antagonists & inhibitors; D014859:Warfarin / Q000008:administration & dosage / Q000009:adverse effects / Q000037:antagonists & inhibitors
D011994:Recombinant Proteins; D014812:Vitamin K; D014859:Warfarin; D015942:Factor VIIa