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Utilization and Clinical Data on In-Hospital, Off-Label Uses of Recombinant Factor VIIa.


John M. Eisenberg Center for Clinical Decisions and Communications Science.


Comparative Effectiveness Review Summary Guides for Clinicians [Internet]. Rockville (MD): Agency for Healthcare Research and Quality (US); 2007-.
AHRQ Comparative Effectiveness Reviews.
2010 Oct 29.


Off-label use of recombinant activated factor VII (rFVIIa) in the hospital setting has increased despite limited comparative data on its effectiveness and safety. How is it being used, and what is the evidence of benefits and harms for treated patients? The U.S. Food and Drug Administration has approved rFVIIa for the treatment and prevention of bleeding in patients with hemophilia A or B with inhibitors, acquired hemophilia, or congenital factor VII deficiency. However, in recent years the off-label use of rFVIIa has increased in the hospital setting to prevent or manage uncontrolled bleeding. The most common in-hospital, off-label uses of rFVIIa are for spontaneous intracranial hemorrhage, bleeding secondary to trauma, and cardiac surgery (see Fig. 1 on the reverse).

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