Real safety is multidimensional
Kogenate® FS, Antihemophilic Factor (Recombinant) with BIO-SET®
Low Inhibitor Rates
- In clinical studies, 0% inhibitor formation observed in (PTPs)1*
- Low incidence (15%)* of inhibitor formation was observed in published clinical trials with previously untreated patients (PUPs) and minimally treated patients (MTPs)2*
*No FVIII inhibitors have developed in the 72 previously treated patients with severe hemophilia A who have received Kogenate FS for a mean of 54 exposure days. In trials with previously untreated and minimally treated patients, half of the patients have achieved 20 or more exposure days, and the incidence of inhibitor formation (15%) is consistent with that observed in other pediatric studies using plasma-derived and recombinant FVIII products.
From the Factory: State-of-the-Art Manufacturing
Multistep Purification Process
- Anion exchange chromatography1
- Solvent/detergent virus inactivation process
- Immunoaffinity chromatography
- Metal chelate chromatography
- Gelatin-sepharose/cation exchange chromatography
- Anion exchange chromatography2
For the family: Exclusive Packaging Features
- Kogenate FS with BIO-SET offers exclusive anticounterfeiting and tamper-evident features, for protection from factory to patient use
- Bayer HealthCare is the first and the only rFVIII manufacturer to provide these important links in the chain of protection
References:
- Abshire TC, Brackmann HH, Scharrer I, et al. Sucrose formulated recombinant human antihemophilic factor VIII is safe and efficacious for treatment of hemophilia A in home therapy—International Kogenate-FS Study Group. Thromb Haemost. 2000; 83(6):811-816.
- Kreuz W, Gill JC, Rothschild C, et al; International Kogenate-FS Study Group. Full-length sucrose-formulated recombinant factor VIII for treatment of previously untreated or minimally treated young children with severe haemophilia A: results of an international clinical investigation. Thromb Haemost. 2005; 9(3):457-467.
