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Safety of high doses of a monoclonal antibody‐purified factor IX concentrate
Author(s) -
Warrier Indira,
Kasper Carol K.,
White Gilbert C.,
Shapiro Amy D.,
Bergman Garrett E.
Publication year - 1995
Publication title -
american journal of hematology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 2.456
H-Index - 105
eISSN - 1096-8652
pISSN - 0361-8609
DOI - 10.1002/ajh.2830490117
Subject(s) - factor ix , medicine , monoclonal antibody , hemostasis , prothrombin complex concentrate , coagulation , antibody , clinical trial , monoclonal , factor v , factor vii , prothrombin complex , coagulopathy , pharmacology , gastroenterology , immunology , thrombosis , warfarin , atrial fibrillation
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. © 1995 wiley‐Liss, Inc.