Healthcare Providers

His life is real. Give him real protection.

Real efficacy in routine prophylaxis and on-demand treatment

• Real joint protection when used as routine prophylaxis in children (0-16years) with no preexisting joint damage ^{1, 2}
• 92.7% of bleeding episodes in PTPs managed with 1 to 2 infusions^1†
• 88.1% of bleeding episodes in PUPs and MTPs managed with 1 to 2 infusions¹**

Real safety is multidimensional

• The most serious adverse reactions are systemic hypersensitivity reactions and the development of hightiter inhibitors necessitating alternative treatments to AHF. 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
  • Central venous access device (CVAD) line-associated infections
• State of the art manufacturing process
• Low inhibitor rate formation in clinical studies*
• Exclusive tamper-evident/anticounterfeiting packaging features

For important risk and use information, please see the full prescribing information.

Real life demands convenience

• BIO-SET^® self-contained needleless rFVIII reconstitution system
• One of the smallest diluent volumes available
  • 2.5 mL for 250 IU, 500 IU, and 1000 IU product sizes
  • 5.0 mL for 2000 IU and 3000 IU product sizes
• Grab & Go packaging—compact and convenient

 

* No FVIII inhibitors developed in 72 PTPs who received Kogenate FS for up to 54 exposure months. In trials with PUPs and MTPs, 88% of patients (53 of 60) achieved 20 or more exposure days, and the incidence of inhibitor formation (15%) is consistent with that observed in other pediatric studies using FVIII products.³ In the pediatric prophylaxis clinical trials, de novo inhibitor development was observed in 8 of 64 patients with negative baseline values (12.5%) ; 2 patients developed high-titer inhibitors and were withdrawn from the study.¹ For important risk and use information, please see the full prescribing information.

^†During clinical trials with previously treated patients; n=5684 mild, moderate or severe bleeding episodes.
**During clinical trials with previously untreated or minimally treated patients; n=1047 mild, moderate or severe bleeding episodes.

References:

1. Kogenate FS with Bio-Set [package insert]. Tarrytown, NY: Bayer HealthCare LLC; 2009.
2. Manco-Johnson MJ, Abshire TC, Shapiro AD, et al. Prophylaxis versus episodic treatment to prevent joint disease in boys with severe hemophilia. N Engl J Med. 2007;357(6):535-44.
3. 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.