Clinical experience with recombinant factor VIIa.

Abstract

Recombinant factor VIIa (rFVIIa) represents a major therapeutic advance in the treatment of haemophilia patients with inhibitors. The efficacy and safety of rFVIIa has been extensively studied in over 1900 surgical and non-surgical bleeding episodes in over 400 patients with haemophilia A or B (with or without inhibitors) or acquired haemophilia. Of 103 evaluable surgical bleeding episodes, the response to treatment with rFVIIa was considered to be either excellent or effective in 81%, 86% and 92% of major, minor and dental bleeding episodes, respectively. Treatment has been evaluated in 518 serious bleeding episodes and the response was considered either excellent or effective in 62% of muscle, 80% of ear, nose and throat, 88% of central nervous system, 76% of joint, and 75% of internal or retroperitoneal bleeding episodes. An excellent safety profile has also been demonstrated: of 1957 treatments with rFVIIa, only 16 serious adverse events have been reported that were considered to be possibly, but not necessarily, related to treatment.

• Authors: J Lusher, J Ingerslev, H Roberts, U Hedner
• Journal: Blood coagulation & fibrinolysis : an international journal in haemostasis and thrombosis (Blood Coagul Fibrinolysis) Vol. 9 Issue 2 Pg. 119-28 (Mar 1998) ISSN: 0957-5235 [Print] England
• PMID: 9622209 (Publication Type: Journal Article, Research Support, Non-U.S. Gov't)

Chemical References

• Recombinant Proteins
• Factor VIIa

Topics

• Clinical Trials as Topic
• Dose-Response Relationship, Drug
• Drug Monitoring
• Factor VIIa (adverse effects, therapeutic use)
• Hemophilia A (drug therapy)
• Hemophilia B (drug therapy)
• Humans
• Recombinant Proteins (adverse effects, therapeutic use)