Concomitant use of the
monoclonal antibody-purified
factor IX concentrate (
Mononine, Armour
Pharmaceutical Company, Collegeville, Pa.) and two
antifibrinolytic agents,
epsilon-aminocaproic acid (EACA;
Amicar, Immunex, Seattle, Wash.) or
tranexamic acid (
AMCA;
Cyklokapron, Kabi Pharmacia, Piscataway, N.J.) was examined for safety and efficacy in patients with
hemophilia B. In a retrospective review of 19 patients treated with
monoclonal antibody-purified
factor IX and EACA on 35 occasions,
bleeding was successfully controlled and no instances of clinical thrombotic complications were reported; one instance of
urticaria resolved without additional treatment. The use of EACA or
AMCA in combination with
monoclonal antibody-purified
factor IX was also examined prospectively in a study of 9 patients.
Bleeding was effectively controlled and no thrombotic events were detected clinically with either
antifibrinolytic agent. No significant changes in hematocrit or
hemoglobin were detected, and there was no evidence of
thrombosis as evaluated clinically and by sensitive molecular markers. It was concluded from both the retrospective and prospective data that
monoclonal antibody-purified
factor IX concentrate in combination with an
antifibrinolytic agent does not activate the coagulation cascade and is a safe and effective treatment for prevention and control of oral
bleeding in
hemophilia B patients.