Recombinant Factor VIIA in the Treatment of Bleeding

Madhu V. Midathada, MD; Paulette Mehta, MD; Milton Waner, MD; Louis M. Fink, MD


Am J Clin Pathol. 2004;121(1) 

In This Article


Off-label use of rFVIIa has been reported following bone marrow transplantation.[89] Blatt et al[89] reported the use of rFVIIa in 3 patients (ages 8.8 to 19 years) with pulmonary hemorrhage (1 patient), hemorrhagic cystitis (3 patients), and gastrointestinal bleeding (2 patients). Transient clinical responses in gross hematuria in 2 patients and in pulmonary hemorrhage were noted within several days of starting rFVIIa, but bleeding in a new site in 2 patients and renewed bleeding of the initial site in the third patient resulted in discontinuation of the drug. No toxic or adverse effects were observed after rFVIIa administration. A case report describes the use of rFVIIa in a man with acute myeloid leukemia following bone marrow transplantation. He had severe persistent bleeding with a low platelet count, abnormal PT and PTT, and did not respond to the conventional treatment. Immediate resolution of bleeding was observed after 2 doses of rFVIIa.[90]

rFVIIa was studied in 6 patients undergoing orthotopic liver transplantation for Child B or C cirrhosis.[91] rFVIIa was given at a dose of 80 µg/kg at the start of the operation. Blood loss and perioperative transfusion requirements were compared with those for matched control subjects. The study group had significantly lower blood loss and transfusion requirements. The effect of rFVIIa on blood loss was evaluated in patients with cirrhosis undergoing orthotopic liver transplantation. Thrombin generation was enhanced in a localized and time-limited matter, but there was no difference in fibrinolysis and no evidence of intravascular coagulation.[92]


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