In-Hospital, Off-Label Uses for rFVIIa1Evidence on Benefits vs. Usual CareEvidence on Harms vs. Usual Care
Spontaneous intracranial hemorrhage*No effect on mortality or functional status. Image clinrfviiafu2.jpg
Attenuation of hematoma expansion. Image clinrfviiafu2.jpg
Increased risk for arterial thromboembolic events, particularly at doses >40 μg/kg of patient body weight. Image clinrfviiafu2.jpg
Adult cardiac surgeryNo effect on mortality, RBC transfusion requirements, or ICU length of stay. Image clinrfviiafu3.jpgIncreased risk for thromboembolic events when compared to usual care. Image clinrfviiafu2.jpg
Body trauma*No consistent effect on mortality. Image clinrfviiafu3.jpg
Possible reduction in acute respiratory distress syndrome. Image clinrfviiafu3.jpg
No effect on thromboembolic events. Image clinrfviiafu3.jpg
Brain traumaNo effect on mortality, Glasgow coma scale, or hematoma volume change. Image clinrfviiafu3.jpgNo effect on thromboembolic events. Image clinrfviiafu3.jpg
Liver transplantation*No effect on mortality, OR time, or ICU length of stay. Image clinrfviiafu3.jpg
Possible reduction in 24-hr RBC transfusion requirements. Image clinrfviiafu3.jpg
No effect on thromboembolic events. Image clinrfviiafu3.jpg
1

In January 2010, an FDA-required warning statement regarding the serious thrombotic events associated with the use of rFVIIa (NovoSeven® RT) outside labeled indications was added to the product insert. This warning was similar to that issued in 2005 for the original formulation of rFVIIa (NovoSeven®).

*

Current evidence does not provide a connection between improvements in indirect outcomes (e.g., reversal of bleeding) with those of direct outcomes (e.g., mortality). Explanations include: 1) bleeding control by itself is not enough to influence direct outcomes, or 2) the risk of overall harms outweighs the potential benefits from indirect outcomes.

Even though the effect of treating spontaneous intracranial hemorrhage with rFVIIa at doses ≤40 μg/kg of patient body weight was not statistically different from zero, there may have been insufficient statistical power to detect a difference.

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

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Comparative Effectiveness Review Summary Guides for Clinicians [Internet].

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