Safety of high doses of a monoclonal antibody-purified factor IX concentrate. The Mononine Study Group.
This report summarizes safety and efficacy information among patients treated with high doses (> 75 U/kg) of a monoclonal antibody-purified factor IX concentrate [coagulation factor IX (human) monoclonal antibody purified)] in two clinical trials. One hundred infusions of this factor 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 patients was rated as "excellent," and there were no thrombotic complications.
Warrier
I
I
Division of Hematology/Oncology, Wayne State University, Detroit, Michigan, USA.
Kasper
C K
CK
White
G C
GC
Shapiro
A D
AD
Bergman
G E
GE
D000328:Adult; D000911:Antibodies, Monoclonal; D004305:Dose-Response Relationship, Drug; D005164:Factor IX / Q000009:adverse effects* / Q000302:isolation & purification / Q000627:therapeutic use*; D006487:Hemostasis; D006801:Humans; D013927:Thrombosis / Q000150:complications / Q000188:drug therapy
D000911:Antibodies, Monoclonal; D005164:Factor IX