Home > Search Results

Results: 2

Comparative Effectiveness of In-Hospital Use of Recombinant Factor VIIa for Off-Label Indications vs. Usual Care [Internet]

Comparative Effectiveness of In-Hospital Use of Recombinant Factor VIIa for Off-Label Indications vs. Usual Care [Internet]

Comparative Effectiveness Reviews - Agency for Healthcare Research and Quality (US)

Version: May 2010

Introduction

This report evaluates the level of evidence currently available to support the effectiveness and safety of using recombinant activated coagulation factor VII (rFVIIa) for clinical indications beyond those approved by the Food and Drug Administration (FDA). rFVIIa is approved for a variety of uses in hemophilia patients who have developed antibody inhibitors that compromise the use of standard factor replacement. Use of this costly biologic product has expanded beyond these hemophilia-related indications to encompass a range of off-label uses that differ from the drug’s FDA approved label. The purpose of this report is two-fold: (1) To profile the full range of clinical indications for which rFVIIa is being used and the types of studies available to evaluate these uses, and (2) To provide a comparative effectiveness review of rFVIIa versus usual care for several clinical indications: intracranial hemorrhage, massive bleeding secondary to trauma, and the selected surgical procedures of cardiac surgery, liver transplantation, and prostatectomy.

Recent Activity

    Your browsing activity is empty.

    Activity recording is turned off.

    Turn recording back on

    See more...