Recombinant factor VIIa to manage major bleeding from newer parenteral anticoagulants.
OBJECTIVE
To evaluate the use of recombinant factor VIIa (rFVIIa) to reverse major bleeding from newer parenteral anticoagulant therapy.


METHODS
MEDLINE/PubMed was searched from January 2000 through December 2009 using the terms recombinant factor VIIa, rFVIIa, NovoSeven, enoxaparin, argatroban, fondaparinux, lepirudin, bivalirudin, idraparinux, nadroparin, hirudin, and desirudin. References of identified articles were reviewed.


RESULTS
Data evaluating the role of rFVIIa to reverse major bleeding from newer parenteral anticoagulant therapy is limited to case reports and small laboratory investigations. Laboratory investigations suggest that rFVIIa may be effective in reversing the hemostatic effects of newer parenteral anticoagulants. In most case reports analyzed, standard interventions for bleeding (eg, fresh frozen plasma, packed red blood cells) were attempted prior to using rFVIIa. Sixteen published cases describe the use of rFVIIa to reverse major bleeding from low-molecular-weight heparins, synthetic pentasaccharides, and direct thrombin inhibitors. Initial doses ranged from 20 to 120 mug/kg. rFVIIa was considered effective or partially effective based upon clinical response in 13 cases. Use was not effective in 3 cases because of a thrombotic event, no change in hemostasis, and death from bleeding complications. As thrombosis is the major safety concern, an individualized risk-benefit assessment is required prior to the use of rFVIIa therapy to restore hemostasis.


CONCLUSIONS
rFVIIa may be considered to manage major refractory bleeding from newer parenteral anticoagulant agents when the benefit is thought to outweigh the thrombotic risk.
Pharmacy Department, Kaiser Permanente Colorado, Aurora, USA.
Kellie A
KA
Vavra
Mark F
MF
Lutz
Maureen A
MA
Smythe
D000925:Anticoagulants / Q000009:adverse effects*; D015942:Factor VIIa / Q000009:adverse effects / Q000627:therapeutic use*; D000077425:Fondaparinux; D006470:Hemorrhage / Q000139:chemically induced* / Q000517:prevention & control*; D006490:Hemostatics / Q000037:antagonists & inhibitors / Q000627:therapeutic use; D006495:Heparin, Low-Molecular-Weight / Q000009:adverse effects / Q000627:therapeutic use; D006801:Humans; D009844:Oligosaccharides / Q000009:adverse effects / Q000627:therapeutic use; D011134:Polysaccharides / Q000009:adverse effects / Q000627:therapeutic use; D011994:Recombinant Proteins / Q000009:adverse effects / Q000627:therapeutic use; D013917:Thrombin / Q000037:antagonists & inhibitors
D000925:Anticoagulants; D006490:Hemostatics; D006495:Heparin, Low-Molecular-Weight; D009844:Oligosaccharides; D011134:Polysaccharides; D011994:Recombinant Proteins; C479958:idraparinux; C103587:recombinant FVIIa; D015942:Factor VIIa; D013917:Thrombin; D000077425:Fondaparinux