Comparative Effectiveness of In-Hospital Use of Recombinant Factor VIIa for Off-Label Indications vs. Usual Care
FDA Approved Indications for rFVIIa
Since 1999, the FDA has approved four separate applications that have gradually expanded the scope of rFVIIa use in hemophilia:
1.Hemophilia A or B with inhibitors for bleeding episodes (March 25, 1999).
2.Bleeding and surgery in congenital factor VII deficiency (July 11, 2005).
3.Surgery and invasive procedures in hemophilia A or B with inhibitors (August 12, 2005).
4.Bleeding and surgery in acquired hemophilia (October 13, 2006).
- Yank V, Tuohy CV, Logan AC, et al. Comparative Effectiveness of In-Hospital Use of Recombinant Factor VIIa for Off-Label Indications vs. Usual Care, Comparative Effectiveness Review 21 (Prepared by Stanford–UCSF Evidence-based Practice Center under Contract No. 290-02-0017). Rockville, MD: Agency for Healthcare Research and Quality; May 2010. AHRQ Publication No. 10-EHC030-EF.
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