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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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Preparing and administering Kogenate® FS, Antihemophilic Factor (Recombinant)

Kogenate FS offers user-friendly features to help make factor preparation easy for you and your child:

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A self-contained, needleless rFVIII reconstitution system.

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Has no exposed needles during reconstitution.

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Comes in a wide range of product sizes and one of the smallest diluent volumes available – for flexibility in dose preparation:

 

 

  • 2.5 mL for 250 IU, 500 IU and 1000 IU vial sizes
  • 5.0 mL for 2000 IU and 3000 IU vial sizes

How should I take Kogenate FS?

Do not attempt to self-infuse unless you have been taught how by your healthcare provider or hemophilia center.

 

See the step-by-step instructions for reconstituting Kogenate FS with Vial Adapter.

 

You should always follow the specific instructions given by your healthcare provider. The steps listed below are general guidelines for using Kogenate FS. If you are unsure of the procedures, please call your healthcare provider before using.

 

  • Call your healthcare provider right away if bleeding is not controlled after using Kogenate FS.
  • Your healthcare provider will prescribe the dose that you should take.
  • Your healthcare provider may need to take blood tests from time to time.
  • Talk to your healthcare provider before traveling. You should plan to bring enough Kogenate FS for your treatment during this time.
  • Carefully handle Kogenate FS. Dispose of all materials, including any leftover reconstituted Kogenate FS product, in an appropriate container.

Understanding vial sizes and dosing Kogenate FS

Kogenate FS comes in a wide range of vial sizes because different types of bleeds and circumstances require different dosages.

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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.