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Vol. 28, No. 2, 1998
Issue release date: March–April 1998
Haemostasis 1998;28:93–98

Activated Recombinant Human Coagulation Factor VII Therapy for Intracranial Hemorrhage in Patients with Hemophilia A or B with Inhibitors

Results of the NovoSeven Emergency-Use Program

Arkin S. · Cooper H.A. · Hutter J.J. · Miller S. · Schmidt M.L. · Seibel N.L. · Shapiro A. · Warrier I.
aMount Sinai Medical Center, Mount Sinai School of Medicine, New York, N.Y., bUniversity of North Carolina, Chapel Hill, N.C., cDepartment of Pediatric Hematology/Oncology, University of Arizona, Tucson, Ariz., dChildren’s Medical Center of Brooklyn, Brooklyn, N.Y., eDivision of Hematology/Oncology, University of Illinois, Urbana, Ill., fChildren’s National Medical Center, Washington, D.C., gDepartment of Pediatrics, Indiana University, Indianapolis, Ind., and hDepartment of Hematology/Oncology, Children’s Hospital of Michigan, Detroit, Mich., USA

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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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Drug Dosage: The authors and the publisher have exerted every effort to ensure that drug selection and dosage set forth in this text are in accord with current recommendations and practice at the time of publication. However, in view of ongoing research, changes in goverment regulations, and the constant flow of information relating to drug therapy and drug reactions, the reader is urged to check the package insert for each drug for any changes in indications and dosage and for added warnings and precautions. This is particularly important when the recommended agent is a new and/or infrequently employed drug.
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