Two years' experience with two recombinant factor VIII concentrates.
Transmission of infectious diseases via the use of plasma concentrates has lent special significance to the manufacture of recombinant coagulation factor concentrates. At present, two factor VIII concentrates manufactured by recombinant DNA technology, produced by Baxter (Recombinate) and Bayer/Miles (Kogenate), are undergoing clinical trials. At the haemophilia centres in Bonn and Frankfurt am Main a total of 4.1 million IU have been used by twelve patients for prophylaxis and treatment for bleeding between 1989 and 1990. The clinical efficacy, particularly in the treatment of bleeding episodes was good and corresponded with that of plasma-derived concentrates. There were no allergic reactions, development of inhibitors or other serious side effects. In laboratory investigations no adverse results were encountered.
Brackmann
H H
HH
Institute of Experimental Haematology and Transfusion Medicine, University of Bonn, Germany.
Aygören
E
E
Scharrer
I
I
Schwaab
R
R
Hammerstein
U
U
Oldenburg
J
J
D000328:Adult; D004341:Drug Evaluation; D005169:Factor VIII / Q000493:pharmacokinetics / Q000627:therapeutic use*; D006467:Hemophilia A / Q000150:complications / Q000188:drug therapy*; D006470:Hemorrhage / Q000188:drug therapy / Q000209:etiology / Q000517:prevention & control; D006801:Humans; D008297:Male; D008875:Middle Aged; D011994:Recombinant Proteins / Q000493:pharmacokinetics / Q000627:therapeutic use; D012449:Safety
D011994:Recombinant Proteins; C078147:F8 protein, human; D005169:Factor VIII