Your body can also make antibodies called "inhibitors," against Kogenate FS, which may stop Kogenate FS from working properly.
Several studies looked at the inhibitor rates of Kogenate® FS Antihemophilic Factor (Recombinant).
Previously Untreated Patients Inhibitor Registry Data
Post marketing registries in previously untreated patients taking Kogenate FS have shown inhibitor development rates of 31-50% which is comparable to previously-reported inhibitor rates for FVIII products. Some of these registries showed a trend towards an increased risk of inhibitor development in PUPs taking Kogenate FS, as compared to another rFVIII product.3
In clinical studies of PUPs and MTPs (N=60), 15% of patients (9 of 60) developed inhibitors2*
*In clinical trials with PUPs and MTPs, 88% of patients (53 of 60) achieved 20 or more exposure days.
In a clinical study of patients (N=64), 12.5% of patients (8 of 64) developed de novo inhibitors in the Joint Outcome Study1†
†2 patients developed high-titer (>5 BU) inhibitors and were withdrawn from the study.1
Product safety and quality – from the start
Our manufacturing process exemplifies Bayer's dedication to the quality and safety of your treatment – from fermentation to purification to filling and freeze drying to packaging.