Adverse events reported in association with the use of monoclonal antibody purified factor VIIIC--Monoclate.
In the 2-year period between October 1987 and October 1989, during which an estimated 3,000 to 4,000 hemophiliacs were treated with Monoclate, spontaneous reports were received on 43 patients who experienced 134 adverse events. The symptomatic adverse events reported have been remarkably few in number and similar in nature to those reported with use of other factor VIII preparations. Monoclate has been shown to have an excellent safety profile and there have been no reports of viral transmission or of unexpected adverse events related to its administration.
Brown
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Medical Affairs, Rorer Central Research, Horsham, PA 19044.
D000293:Adolescent; D000707:Anaphylaxis / Q000209:etiology; D000911:Antibodies, Monoclonal; D002648:Child; D005169:Factor VIII / Q000009:adverse effects*; D006467:Hemophilia A / Q000188:drug therapy; D006801:Humans; D008297:Male; D008875:Middle Aged
D000911:Antibodies, Monoclonal; D005169:Factor VIII