Off-label use of recombinant factor VIIa in two tertiary hospitals in Queensland

Donovan, Peter J., Iedema, Joel, McLeod, Donald S., Kubler, Paul and Pillans, Peter (2013) Off-label use of recombinant factor VIIa in two tertiary hospitals in Queensland. ANZ Journal of Surgery, 83 3: 149-154. doi:10.1111/ans.12005

Author Donovan, Peter J.
Iedema, Joel
McLeod, Donald S.
Kubler, Paul
Pillans, Peter
Title Off-label use of recombinant factor VIIa in two tertiary hospitals in Queensland
Journal name ANZ Journal of Surgery   Check publisher's open access policy
ISSN 1445-1433
Publication date 2013-03
Year available 2012
Sub-type Article (original research)
DOI 10.1111/ans.12005
Open Access Status
Volume 83
Issue 3
Start page 149
End page 154
Total pages 6
Place of publication Richmond, VIC, Australia
Publisher Wiley-Blackwell
Collection year 2013
Language eng
Formatted abstract
Background: Recombinant factor VIIa (rFVIIa) is used for many off-label indications without high quality evidence to support its efficacy. The aim of this study was to determine indications for use of off-label rFVIIa, efficacy and safety, and adherence to institutional guidelines.

We performed a retrospective review of off-label rFVIIa at two tertiary hospitals from 2007 to 2010.

Results: One hundred forty-five administrations were identified and analysed. Haemorrhage associated with cardiac surgery made up one-third of all rFVIIa usage, with trauma (20%) and other surgery (11%) the next most frequent indications. Compared with all others, cardiac surgery patients were older (60.0 years versus 47.4 years, P < 0.001) and had lower pre-rFVIIa transfusion requirements, a higher subjective response rate (88% versus 46%, P < 0.001) and lower mortality rates (6.1% versus 33%, P < 0.001), but higher rates of arterial thrombormbolic events (16.7% versus 2.1%, P = 0.002). Most patients received only one or two doses (n = 137; 95%), with no subject receiving a third or subsequent dose having an appreciable reduction in bleeding. Only a small number of patients (n = 15; 10.3%) had rFVIIa administered in accordance with our institutions' guidelines.

Conclusion: Patients administered rFVIIa for haemorrhage not associated with cardiac surgery were severely unwell. Despite lack of evidence, administration of rFVIIa may be justified by the high mortality rate, but more than two doses are unlikely to provide further benefit. The high rate of arterial thromboembolism in cardiac surgical patients raises risk-benefit considerations. Adherence to our institutions' guidelines was poor.
Keyword Adverse drug event
Therapeutic use
Off-label use
Recombinant FVIIa
Q-Index Code C1
Q-Index Status Confirmed Code
Institutional Status UQ
Additional Notes Article first published online: 9 November 2012.

Document type: Journal Article
Sub-type: Article (original research)
Collections: Official 2013 Collection
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