Bayer Kogenate FS

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	© 2008 Bayer HealthCare LLC BAYER, the Bayer Cross, and Kogenate are registered trademarks of Bayer BIO-SET is a trademark of Biodome SAS

Product Comparison

The charts below compare information about the available recombinant FVIII treatments for hemophilia A. These charts demonstrate why Kogenate^® FS offers your patients with hemophilia A all of the benefits of a recombinant therapy without the need for a large reconstitution volume. Bayer uses innovative manufacturing processes to enhance the safety of Kogenate^® FS as compared to the processes used to manufacture most other factor VIII products.

	Kogenate^® FS* Antihemophilic Factor (Recombinant) Formulated with Sucrose¹	Recombinate™ Antihemophilic Factor (Recombinant)²	Advate™ Antihemophilic Factor (Recombinant) Plasma/Albumin- Free Method⁴	ReFacto^® Antihemophilic Factor (Recombinant)³	Helixate FS^® ⁵** Antihemophilic Factor (Recombinant) Formulated with Sucrose
Distributor	Bayer HealthCare	Baxter International, Inc.	Baxter International, Inc.	Wyeth Pharmaceuticals, Inc.	ZLB Behring
Reconstituted Volume	2.5 mL	10 mL	5 mL	4 mL	2.5 mL
Diluent Type	Water	Water	Water	Normal Saline	Water
Number of Virus Inactivation Steps	2	1	2	2	2
Molecular Structure	Similar to natural molecule	Similar to natural molecule	Similar to natural molecule	B-domain deleted	Similar to natural molecule
Assay	One stage	One stage	Not described in Prescribing Information	Chromogenic assay	One stage
Half-life (hours)	13.3±1.6	14.6±4.9	11.98±4.28	14.5±5.3	13.3±1.6
Storage	Refrigeration or room temperature up to 3 months***	Refrigeration or room temperature	Refrigeration or room temperature up to 6 months	Refrigeration or room temperature up to 3 months	Refrigeration or room temperature up to 3 months***
Cell Nutrient	Human serum albumin	Bovine serum albumin	No human albumin	Human serum albumin	Human serum albumin
Final Formulation	No Human Albumin	Human Albumin	No Human Albumin	No Human Albumin	No Human Albumin
Stabilizer	Sucrose	Human serum albumin	Trehalose (similar to sucrose)	Sucrose	Sucrose
Patient Assistance Program	Yes	Yes	Yes	Yes	Yes
Patient Coupon Program	Yes	Yes	Yes	No	Yes
Electronic Treatment Diary	Yes	Yes	Yes	No	No

*Also distributed as Helixate^® FS (ZLB Behring)

**Manufactured by Bayer HealthCare

***Refrigerate at 36°F- 46°F (2°C- 8°C). Storage of lyophilized powder at room temperature (up to 25°C or 77°F) for 3 months, such as in home treatment situations, may be done. Do not use after expiration date. Do not freeze. Protect from light.

Volume of Diluent Needed for 100% FVIII Increase

Kogenate^® FS offers your patients with hemophilia A all of the benefits of a recombinant therapy without the need for a large reconstitution volume

Body Weight	Dose (IUs)	Kogenate^® FS	Recombinate™	Advate™	ReFacto^®	Helixate^® FS
100 kg	5000	12.5 mL	50 mL	20 mL	12 mL	12.5 mL
70 kg	3500	10 mL	40 mL	15 mL	12 mL	10 mL
40 kg	2000	5 mL	20 mL	10 mL	4 mL	5 mL
15 kg	750	5 mL	20 mL	10 mL	8 mL	5 mL
7 kg	350	2.5 mL	10 mL	5 mL	4 mL	2.5 mL

Volume of Diluent Needed for 50% FVIII Increase

Body Weight	Dose (IUs)	Kogenate^® FS	Recombinate™	Advate™	ReFacto^®	Helixate^® FS
100 kg	2500	7.5 mL	30 mL	10 mL	8 mL	7.5 mL
70 kg	1750	7.5 mL	30 mL	10 mL	4 mL	7.5 mL
40 kg	1000	2.5 mL	10 mL	5 mL	4 mL	2.5 mL
15 kg	375	2.5 mL	10 mL	5 mL	4 mL	2.5 mL
7 kg	175	2.5 mL	10 mL	5 mL	4 mL	2.5 mL

¹ Kogenate^® FS [package insert]. Elkhart IN: Bayer HealthCare; 2001. Kogenate^® is a registered trademark of Bayer AG, Germany.
² Recombinate™ [package insert]. Glendale CA: Baxter Healthcare Corporation; 2001. Recombinate™ is a trademark of Baxter International, Inc.
³ ReFacto^® [package insert]. Cambridge, MA: Genetics Institute, Inc.; 2001. ReFacto^® is a registered trademark of Genetics Institute, Inc.
⁴ Advate™ [package insert]. Glendale, CA: Baxter Healthcare Corporation; 2003. Advate™ is a registered trademark of Baxter International, Inc.
⁵ Helixate^® [package insert]. Kankakee, IL: Aventis Behring; 2002. Helixate^® is a registered trademark of Aventis Behring LLC.

Kogenate® FS, Antihemophilic Factor (Recombinant), is a recombinant factor VIII treatment indicated for the treatment of hemophilia A. The most frequently reported adverse events were local injection site reactions, dizziness, and rash. Known intolerance or allergic reactions to constituents of the preparation is a contraindication to the use of Kogenate® FS. Known hypersensitivity to mouse or hamster protein may be a contraindication to the use of Kogenate® FS. For important safety and use information, please see the full prescribing information.

Please consult your health care provider prior to making any lifestyle changes. The images used on this site do not necessarily represent actual Hemophilia patients.