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.

Abstract

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.

• Authors: S Arkin, H A Cooper, J J Hutter, S Miller, M L Schmidt, N L Seibel, A Shapiro, I Warrier
• Journal: Haemostasis (Haemostasis) 1998 Mar-Apr Vol. 28 Issue 2 Pg. 93-8 ISSN: 0301-0147 [Print] Switzerland
• PMID: 10087434 (Publication Type: Clinical Trial, Journal Article)

Chemical References

• Recombinant Proteins
• Factor VIIa

Topics

• Adult
• Cerebral Hemorrhage (drug therapy, etiology)
• Child, Preschool
• Factor VIIa (administration & dosage, adverse effects)
• Hemophilia A (complications)
• Hemophilia B (complications)
• Humans
• Infant
• Injections, Intravenous
• Male
• Recombinant Proteins (administration & dosage)