SAFETY OF HIGH-DOSES OF A MONOCLONAL ANTIBODY-PURIFIED FACTOR-IX CONCENTRATE

This report summarizes safety and efficacy information among patients treated with high doses (>75 U/kg) of a monoclonal antibody-purified f actor IX concentrate [coagulation factor IX (human) monoclonal antibod y purified)] in two clinical trials, One hundred infusions of this fac tor IX concentrate at doses >75 U/kg were administered to 35 patients, six of whom had experienced thrombotic complications during previous treatment with prothrombin complex concentrate, Hemostasis in all pati ents was rated as ''excellent,'' and there were no thrombotic complica tions. (C) 1995 Wiley-Liss, Inc.