Inhibitor rates

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5 BU) inhibitors and were withdrawn from the study.1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

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