Because product safety and quality are important
Our manufacturing process exemplifies Bayer's dedication to the quality and safety of your treatment – from fermentation to purification to filling and freeze drying to packaging. For example:
We produce Kogenate® FS, Antihemophilic Factor (Recombinant), using continuous perfusion technology to obtain the factor. This continuous harvesting allows FVIII proteins to spend less time in the fermenter, leading to a consistent and high-quality FVIII molecule.
Multistep purification process
We use a multistep purification process designed to purify rFVIII and remove contaminating substances.
Filling and freeze-drying in a high sterility environment
In the fill room, we fill our vials with the proper amount of Kogenate FS and then freeze-dry it to create a powder. The fill room meets the high sterility standards set by the pharmaceutical industry.
Twice-inspected vials in exclusive tamper-evident cartons
We personally inspect the glass vials that contain Kogenate FS twice to ensure quality. Then, we place them into cartons with exclusive anti-counterfeiting and tamper-evident features for protection from the factory all the way to your use.
Speed, ease and convenience
One compact box is small enough to fit in your backpack, briefcase or purse with ease, so you can infuse on the go.
Kogenate® FS Antihemophilic Factor (Recombinant) is a medicine used to replace clotting factor (factor VIII or antihemophilic factor) that is missing in people with hemophilia A.
Kogenate FS is used to treat and control bleeding in adults and children with hemophilia A. Your healthcare provider may give you Kogenate FS when you have surgery. Kogenate FS can reduce the number of bleeding episodes in adults and children when used regularly (prophylaxis). Kogenate FS can reduce the risk of joint damage in children without pre-existing joint damage when used regularly.
Kogenate FS is not used to treat von Willebrand disease.
Important Safety Information
You should not use Kogenate FS if you are allergic to rodents (like mice and hamsters) or are allergic to any ingredients in Kogenate FS.
Tell your healthcare provider if you have been told you have heart disease or are at risk for heart disease.
You could have an allergic reaction to Kogenate FS. Call your healthcare provider right away and stop treatment if you get rash or hives, itching, tightness of the chest or throat, difficulty breathing, light-headed, dizziness, nausea or a decrease in blood pressure.
Your body can make antibodies, called “inhibitors,” against Kogenate FS, which may stop Kogenate FS from working properly. Consult with your healthcare provider to make sure you are carefully monitored with blood tests for the development of inhibitors to factor VIII.
Other common side effects of Kogenate FS are local injection site reactions (pain, swelling, irritation at infusion site) and infections from implanted injection device. Tell your healthcare provider about any side effect that bothers you or does not go away.
Call your healthcare provider right away if bleeding is not controlled after using Kogenate FS.
For important risk and use information, please see full prescribing information.