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Activated recombinant human coagulation factor VII (rFVIIa) is a promising new therapeutic agent for patients with hemophilia A or B with inhibitors who experience serious bleeding episodes or who need coverage during surgical procedures. This open-label, uncontrolled, emergency-use study evaluated the efficacy and safety of rFVIIa in 11 hemophiliac patients and 1 FVII-deficient patient with life-threatening intracranial hemorrhage previously unresponsive to one or more alternative therapies. rFVIIa effectively controlled intracranial hemorrhage in 10 of the 12 patients. Patients with hemophilia A or B received an average of 96.9 rFVIIa injections over 14.7 days with a mean total administration of 153.3 mg, corresponding to 8.1 mg/kg. Most reported adverse events were considered to be unrelated to rFVIIa therapy. These findings suggest that rFVIIa is an effective and well-tolerated therapeutic option in the management of central nervous system bleeding in patients with hemophilia A or B with inhibitors.
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- Eyster ME, Gill FM, Blatt PM, Hilgartner MW, Ballard JO, Kinney TR, the Hemophilia Study Group: Central nervous system bleeding in hemophiliacs. Blood 1978;51:1179–1188.
- Bray GL, Luban NL: Hemophilia presenting with intracranial hemorrhage. Am J Dis Child 1987;141:1215–1220.
- Yoffe G, Buchanan GR: Intracranial hemorrhage in newborn and young infants with hemophilia. J Pediatr 1988;113:333–336.
- Martinowitz U, Heim M, Tadmor R, Eldor A, Rider I, Findler G, Sahar A, Ramot B: Intracranial hemorrhage in patients with hemophilia. Neurosurgery 1986;18:538–541.
- Lusher JM: Management of hemophiliacs with inhibitors; in Hilgartner MW, Pochedly C (eds): Hemophilia in the Child and Adult, ed 3. New York, Raven Press, 1989.
- Hedner U, Glazer S: Management of hemophilia patients with inhibitors. Hematol Oncol Clin North Am 1992;6:1035.
- Ingerslev J, Freidman D, Gastineau D, Gilchrist G, Johnsson H, Lucas G, McPherson J, Preston E, Scheibel E, Shuman M: Major surgery in haemophilic patients with inhibitors using recombinant factor VIIa. Haemostasis 1996;26(suppl 1):118–123.
- Schmidt ML, Gamerman S, Smith HE, Scott JP, DiMichele DM: Recombinant activated factor VII (rFVIIa) therapy for intracranial hemorrhage in hemophilia A patients with inhibitors. Am J Hematol 1994;47:36–40.
- Hedner U: Experiences with recombinant factor VIIa in haemophiliacs. Curr Stud Hematol Blood Transfus 1991;58:63–68.
- Maliekel K, Rana N, Green D: Recombinant factor VIIa in the management of a pseudotumor in acquired hemophilia. Haemophilia 1997;3:54–58.
- Doughty HA, Northeast A, Sklair L, Roques T, Young AE, Savidge GF, Hunt BJ: The use of recombinant factor VIIa in a patient with acquired hemophilia A undergoing surgery. Blood Coagul Fibrinolysis 1995;6:125–128.
- Macik BG, Lindley CM, Lusher J, Sawyer WT, Bloom AL, Harrison JF, Baird-Cox K, Birch K, Glazer S, Roberts HR: Safety and initial clinical efficacy of three dose levels of recombinant activated factor VII (rFVIIa): Results of a phase I study. Blood Coagul Fibrinolysis 1993;4:521–527.
- Majumdar G, Phillips JK, Lavallee H, Savidge GF: Recombinant factor VIIa for intracranial hemorrhage in a Jehovah’s Witness with severe hemophilia A and factor VIII inhibitors. Blood Coagul Fibrinolysis 1993;4:1031–1033.