Reversal of warfarin-induced excessive anticoagulation with recombinant human factor VIIa concentrate.
BACKGROUND
Bleeding associated with warfarin anticoagulation correlates directly to duration and degree of international normalized ratio (INR) elevation above the therapeutic range. Safe and rapid reversal of excessive anticoagulation is occasionally needed to treat or avoid hemorrhagic complications.


OBJECTIVE
To evaluate the efficacy and safety of human recombinant factor VIIa (rFVIIa) concentrate in persons requiring rapid reversal of the effects of warfarin.


METHODS
Uncontrolled case series.


METHODS
Academic medical center.


METHODS
13 patients with critically increased INRs requiring immediate reversal of warfarin-induced anticoagulation.


METHODS
Prothrombin time and INR were measured before and after administration of varying doses of rFVIIa.


RESULTS
Critically prolonged INR and bleeding complications were treated successively and rapidly in all patients, regardless of rFVIIa dose (range, 15 to 90 microg/kg of body weight). Indications for use of rFVIIa included an INR greater than 10 in high-risk persons (n = 5), clinical hemorrhage (n = 4), and diagnostic or therapeutic procedures (n = 4).


CONCLUSIONS
Safe, rapid, and effective administration of rFVIIa corrects critically prolonged INRs and can avert or reverse bleeding associated with warfarin anticoagulation.
Deveras
Ruby Anne E
RA
Division of Hematology and Oncology, Georgetown University Medical Center, 3800 Reservoir Road NW, Washington, DC 20007-2197, USA. rad@georgetown.edu
Kessler
Craig M
CM
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000925:Anticoagulants / Q000009:adverse effects*; D001777:Blood Coagulation / Q000187:drug effects*; D005167:Factor VII / Q000627:therapeutic use*; D015942:Factor VIIa; D005260:Female; D006470:Hemorrhage / Q000517:prevention & control*; D006801:Humans; D019934:International Normalized Ratio; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D011517:Prothrombin Time; D011994:Recombinant Proteins / Q000627:therapeutic use*; D014859:Warfarin / Q000009:adverse effects*
D000925:Anticoagulants; D011994:Recombinant Proteins; D014859:Warfarin; D005167:Factor VII; C103587:recombinant FVIIa; D015942:Factor VIIa