Rational Use of Recombinant Factor VIIa in Clinical Practice

Abstract

In the United States, the FDA-approved indications for recombinant factor VIIa is for bypassing inhibitors to factors VIII and IX in patients with hemophilia A and B respectively and for treatment of congenital factor VII deficiency. In European countries, rFVIIa is licensed for the above indications as well as for Glanzmann's thrombasthenia. In absence of high-quality data favoring off-label use of this agent and laboratory test to predict response to this agent, and in view of high cost of rFVIIa, off-label use of recombinant factor VIIa should be restricted to only when hemorrhage has not responded to transfusion or other conventional therapy. It appears, two such conditions where recombinant factor VIIa may be beneficial are traumatic and postpartum hemorrhages.

Use of low dose of rFVIIa (recombinant Factor VII activated) to control late bleeding after percutaneous dilational tracheostomy

“…Thrombosis is one of the most serious complications. However, it has been shown that even high doses as 346 mcg/kg may be well tolerated in hemophilic patients . The reported incidence of thromboembolic event ranged from 1% to 2% up to 9.8% .…”

“…6,8,9 It is not associated with the risk of blood-transmitted diseases, as a recombinant product is not derived from human or animal plasma. 10 Thrombosis is one of the most serious complications. However, it has been shown that even high doses as 346 mcg/kg may be well tolerated in hemophilic patients.…”

“…However, it has been shown that even high doses as 346 mcg/kg may be well tolerated in hemophilic patients. 10 The reported incidence of thromboembolic event ranged from 1% to 2% up to 9.8%. 11 A retrospective study analyzing the use of rFVIIa between 2000 and 2008 showed that in 97% of the time it was used "off label".…”

Anesthetic Care of a Patient With Bernard-Soulier Syndrome for Posterior Spinal Fusion

“…In addition, we chose to use recombinant factor VIIa (rFVIIa), a synthetic hemostatic agent originally used to treat bleeding in hemophilia A patients who had developed inhibitors to factor VIII [22,23]. Given its integral effect of coagula- tion function, rFVIIa has also been used to treat bleeding of various other etiologies in many clinical scenarios.…”

Successful synthesis of active human coagulation factor VII by co-expression of mammalian gamma-glutamyl carboxylase and modification of vit.K cycle in Drosophila Schneider S2 cells

“…Recombinant activated FVII (rFVIIa) has been approved for the treatment of hemophilia and congenital FVII deficiency, and can also restore coagulopathy in traumatic or postoperative bleeding and postpartum hemorrhage (Dutta and Verma 2014). Several mammalian cell lines including HEK293 human embryonic kidney, Chinese hamster ovary, and baby hamster kidney cells have been used to synthesize recombinant FVII and other vit.K-dependent proteins (Bohm et al 2015); however, as the yield is low, a more efficient large-scale culture system is needed.…”