Kogenate® FS: Therapy For Hemophilia A
Real safety is multidimensional
- State of the art purification process
- Low inhibitor rates*
- Exclusive tamper-evident/anticounterfeiting packaging features
- The most common adverse reactions observed in clinical trials were inhibitor formation in previously untreated or minimally treated patients, skin-associated hypersensitivity reactions, infusion site reactions, and central venous access device (CVAD) line-associated infections.
Real efficacy is long-standing
- Proven protection, with 20 years of clinical experience§
- 93.5% of bleeding episodes managed with 1 to 2 infusions†1
- Now approved as routine prophylaxis in children (0-16 years old) with no pre-existing joint damage
Real life demands convenience
- BIO-SET® self-contained needleless rFVIII reconstitution system
- Small volume diluent for fast, easy treatment‡
- Grab & Go packaging—compact, complete, convenient
* 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.
§ With the Kogenate® product line.
† During clinical trials with previously treated patients; n=2585 mild, moderate or severe bleeding episodes.
‡2.5 mL for 250 IU, 500 IU, and 1000 IU product sizes; 5.0 mL for 2000 IU and 3000 IU product sizes
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.
