J. Oldenburg et al., REPORT ON EXPERIENCES WITH 2 RECOMBINANT FACTOR-VIII CONCENTRATES - KOGENATE(R) (BAYER) AND RECOMBINATE(R) (BAXTER), Infusionstherapie und Transfusionsmedizin, 22, 1995, pp. 60-62
Recently two recombinant factor VIII concentrates, Kogenate(R) (Bayer)
and Recombinate(R) (Baxter), were licensed. The results obtained in c
linical trials of nearly 300 patients over a time period up to 5 years
and our own experience from 112 patients, receiving a total of 29 mil
lion units, showed a good clinical and laboratory parameter response i
n prophylactic substitution, therapy of bleeding episodes and during o
perations. Side-effects were rare and predominantly were of mild chara
cter. Inhibitor incidence was not increased. Recombinant factor VIII c
oncentrates obviously did not affect the patients' immune systems. The
results should encourage a stepwise increase in the number of patient
s treated with recombinant factor VIII concentrates.