Consider Switching to Kogenate® FS
Kogenate FS offer rFVIII users a safe, reliable alternative when you need to change your rFVIII therapy.
If your supplier no longer offers the recombinant factor VIII product you use, or you're looking for a product that offers real convenience and protection, consider Kogenate FS antihemophilic factor (recombinant) with BIO-SET® needleless reconstitution system.
Real efficacy and safety
- Proven protection, with 20 years of clinical experience*
- Now approved as routine prophylaxis in children with no pre-existing joint damage
- The first rFVIII indicated for use as routine prophylaxis to reduce the frequency of bleeding episodes and risk of joint damage in children (0 – 16 years old) with no pre-existing joint damage3
- Low rate of inhibitor development in clinical studies with PUPs, PTPs and MTPs †, ‡, +++, §
- Documented history of efficacy in PUPs, PTPs and MTPs1, 2
- Multistep purification process with 2 virus inactivation steps
- Exclusive anti-counterfeiting and tamper-evident features for protection
- Bayer HealthCare is the first rFVIII manufacturer to provide these important links in the chain of protection
- Most adverse events were associated with central venous access, and there were no differences between the routine prophylaxis group and the episodic group in the study.
§ 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.
Real convenience
- The only self-contained, needleless rFVIII reconstitution system
- Convenient Grab & Go packaging containing the materials necessary for safe and fast rFVIII treatment
- Low reconstitution volume**
- May be administered over 1-15 minutes; based on individual patient tolerability
- Should be stored under refrigeration, or can be stored at room temperature for up to 3 months
- Kogenate® FS with BIO-SET® is widely covered on commercial insurance plans and by Medicare and Medicaid
Please consult with your healthcare provider to determine if Kogenate FS is appropriate for you.
Now you can try Kogenate FS with BIO-SET at no cost, to see if it’s right for you.€
To find out more about the real life protection of Kogenate FS, contact a local hematology account executive.
* With the Kogenate® product line.
† PUPS=previously untreated patients
‡ PTPs=previously treated patients
+++ MTPs=minimally treated patients
** 2.5 mL for 250 IU, 500 IU and 1000 IU product sizes; 5.0 mL for 2000 IU and 3000 IU product sizes.
€ Please note that patients previously enrolled in the Kogenate FS Free Trial program and patients currently receiving Kogenate FS therapy are not eligible to participate in the program.
References:
1. 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.
2.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.
3. For important risk and use information, please see the full prescribing information.