Kogenate^® FS

Real safety is multidimensional

Important safety information

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

Low Inhibitor Rates in clinical studies

In clinical studies, 0% (0 of 72 patients) inhibitor formation observed in previously treated patients (PTPs)^1*
15% (9 of 60 patients) inhibitor formation observed in previously untreated patients (PUPs) and minimally treated patients (MTPs)^1†
In the pediatric prophylaxis clinical trials, de novo inhibitor development was observed in 8 of 64 patients with negative baseline values (12.5%);
Two patients developed high-titer inhibitors and were withdrawn from the study.³

0^%

(0 of 72 patients)

inhibitor formation observed in PTPs^1*

15^%

(9 of 60 patients)

inhibitor formation observed in PUPs
and MTPs^1†

12.5^%

(8 of 64 patients)

developed de novo inhibitors in the
Joint Outcomes Study^3‡

*No FVIII inhibitors developed in 72 who received Kogenate^® FS, antihemophilic factor (recombinant), 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 is consistent with that observed in other pediatric studies using FVIII products.²

‡ 2 patients developed high tier (>5 BU) inhibitors and were withdrawn from the study.³

References

Kogenate FS with Bio-Set [package insert]. Tarrytown, NY: Bayer HealthCare LLC; 2009.
Kreuz W, Gill JC, Rothschild C, et al. Full-length sucrose-formulated recombinant factor VIII for treatment of previously untreated or minimally treated young children with severe haemophilia A. Thromb Haemost. 2005;93(3):457-467.
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):535-544.