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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. Continue reading below 

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Inhibitor rates

 

Your body can also make antibodies called "inhibitors," against Kogenate FS, which may stop Kogenate FS from working properly.

 

Several studies looked at the inhibitor rates of Kogenate® FS Antihemophilic Factor (Recombinant).

 

Previously Untreated Patients Inhibitor Registry Data

Post marketing registries in previously untreated patients taking Kogenate FS have shown inhibitor development rates of 31-50% which is comparable to previously-reported inhibitor rates for FVIII products. Some of these registries showed a trend towards an increased risk of inhibitor development in PUPs taking Kogenate FS, as compared to another rFVIII product.3

 

In clinical studies of PUPs and MTPs (N=60), 15% of patients (9 of 60) developed inhibitors2*

 

*In clinical trials with PUPs and MTPs, 88% of patients (53 of 60) achieved 20 or more exposure days.

 

In a clinical study of patients (N=64), 12.5% of patients (8 of 64) developed de novo inhibitors in the Joint Outcome Study1

 

†2 patients developed high-titer (>5 BU) inhibitors and were withdrawn from the study.1

 

Product safety and quality – from the start

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Find Your Local Rep

Get support. Be connected.

Our support program is designed to connect you to people, resources, and personalized information related to hemophilia A.

Sign up now

Your treatment for the adventures ahead.

Learn more

  Indications

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.

References

1. 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.

 

2. Kreuz W, Gill JC, Rothschild C, et al; the International Kogenate-FS Study Group. Full-length sucrose-formulated recombinant factor VIII for treatment of previously untreated or minimally treated young children with severe hemophilia A: results of an international clinical investigation. Thromb Haemost. 2005;93(3):457-467

 

3. Kogenate FS with Vial Adapter [package insert]. Whippany, NJ: Bayer LLC; 2016.