Safety profile of recombinant factor VIIa.

Abstract:

:Recombinant factor VIIa (rFVIIa; NovoSeven(R), Novo Nordisk, Bagsvaerd, Denmark) has been used for many years in the successful management of bleeding episodes in patients with hemophilia and inhibitors. More recently, rFVIIa has also shown considerable success as a hemostatic agent in trauma and surgery patients without pre-existing coagulopathy. Despite extensive and varied usage of rFVIIa, the incidence of serious adverse events associated with its use is less than 1%; however, there remain concerns regarding the agent's potential to induce thrombosis. This paper will review the safety profile of rFVIIa by examining existing clinical evidence, and will demonstrate that the isolated thrombotic events reported following rFVIIa treatment are due primarily to an improvement in the coagulation mechanism rather than rFVIIa treatment per se. The demonstrated safety of rFVIIa is probably due to its localization to injured areas of the vascular tree by binding to tissue factor (TF) and activated platelets at the bleeding site, thus avoiding systemic activation of coagulation. Finally, those situations in which rFVIIa therapy may not be safe, such as disseminated intravascular coagulation (DIC) and sepsis, will also be discussed.

journal_name

Semin Hematol

journal_title

Seminars in hematology

authors

Roberts HR,Monroe DM 3rd,Hoffman M

doi

10.1053/j.seminhematol.2003.11.019

subject

Has Abstract

pub_date

2004-01-01 00:00:00

pages

101-8

issue

1 Suppl 1

eissn

0037-1963

issn

1532-8686

pii

S0037196303003135

journal_volume

41

pub_type

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