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The Judicious Use of Recombinant Factor VIIa.

Publication ,  Other
Goodnough, LT; Levy, JH
Published in: Semin Thromb Hemost
March 2016

Recombinant activated factor VIIa (rFVIIa) is a prohemostatic agent initially approved for use in hemophilia patients with inhibitors and recently for Glanzmann thrombasthenia. Despite its approval indications, rFVIIa has also been used for a diverse range of off-label indications to treat bleeding related to traumatic injury, major hemorrhage following surgery, intracranial hemorrhage, and for uncontrolled bleeding as a prothrombotic hemostatic agent. Despite its off-label use, the benefit of rFVIIa in most nonhemophilia settings remains uncertain as the majority of clinical trials have not consistently demonstrated beneficial effects as determined by reduced bleeding, decreased blood product utilization, or have not demonstrated a mortality benefit. As with any prohemostatic agent, the risk of thromboembolic events is increased when rFVIIa is used off-label. Pooled data from randomized nonhemophilia studies report an increased risk in the elderly for arterial thromboses, although most individual trials have been underpowered to determine adverse thrombotic events. The causes of thrombotic adverse events associated with off-label use of rFVIIa may be due to an increased risk of adverse events due to critical illness or due to higher doses of rFVIIa used in off-label trials. Without clearly supportive data, physicians should consider risk versus benefit and exercise restraint using rFVIIa in off-label settings. Further, evidence-based guidelines should be developed by professional organizations, and additional randomized controlled clinical trials are needed to further assess the efficacy and safety of off-label rFVIIa use.

Duke Scholars

Published In

Semin Thromb Hemost

DOI

EISSN

1098-9064

Publication Date

March 2016

Volume

42

Issue

2

Start / End Page

125 / 132

Location

United States

Related Subject Headings

  • Thrombosis
  • Recombinant Proteins
  • Randomized Controlled Trials as Topic
  • Off-Label Use
  • Humans
  • Hemorrhage
  • Factor VIIa
  • Cardiovascular System & Hematology
  • 3201 Cardiovascular medicine and haematology
  • 1103 Clinical Sciences
 

Citation

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Goodnough, L. T., & Levy, J. H. (2016). The Judicious Use of Recombinant Factor VIIa. Semin Thromb Hemost. United States. https://doi.org/10.1055/s-0035-1569068
Goodnough, Lawrence Tim, and Jerrold H. Levy. “The Judicious Use of Recombinant Factor VIIa.Semin Thromb Hemost, March 2016. https://doi.org/10.1055/s-0035-1569068.
Goodnough LT, Levy JH. The Judicious Use of Recombinant Factor VIIa. Vol. 42, Semin Thromb Hemost. 2016. p. 125–32.
Goodnough, Lawrence Tim, and Jerrold H. Levy. “The Judicious Use of Recombinant Factor VIIa.Semin Thromb Hemost, vol. 42, no. 2, Mar. 2016, pp. 125–32. Pubmed, doi:10.1055/s-0035-1569068.
Goodnough LT, Levy JH. The Judicious Use of Recombinant Factor VIIa. Semin Thromb Hemost. 2016. p. 125–132.
Journal cover image

Published In

Semin Thromb Hemost

DOI

EISSN

1098-9064

Publication Date

March 2016

Volume

42

Issue

2

Start / End Page

125 / 132

Location

United States

Related Subject Headings

  • Thrombosis
  • Recombinant Proteins
  • Randomized Controlled Trials as Topic
  • Off-Label Use
  • Humans
  • Hemorrhage
  • Factor VIIa
  • Cardiovascular System & Hematology
  • 3201 Cardiovascular medicine and haematology
  • 1103 Clinical Sciences