IMPORTANT SAFETY INFORMATION You should not use Kogenate FS or Helixate FS if you are allergic to rodents (like mice and hamsters) or are allergic to any ingredients in Kogenate FS or Helixate FS. Continue reading below >

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For patients on
Helixate® FS
Antihemophilic Factor (Recombinant)

You can continue Factor VIII treatment with Kogenate® FS
Antihemophilic Factor (Recombinant)

Important facts about Helixate FS and Kogenate FS

Kogenate FS and Helixate FS contain the same factor (active pharmaceutical ingredient and formulation) and are manufactured by Bayer in the same facility

Bayer has an agreement to supply this factor to CSL Behring, who markets it as Helixate FS

Bayer's supply agreement with CSL Behring will continue through December 31, 2017, at which point Helixate FS will no longer be manufactured

Bayer will continue to manufacture Kogenate FS

Kogenate FS and Helixate FS have different reconstitution systems

Kogenate FS is covered by all major insurance companies

CVS/Caremark and United Healthcare announced that Helixate FS will no longer be covered under some of their commercial prescription plans as of January 1, 2017

You can check with your insurance provider for any recent changes to the coverage status of Helixate FS

Talk to your healthcare provider to see if Kogenate FS may be appropriate for you.

Follow the 3 steps below to switch to Kogenate FS

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1.Connect with Bayer Access Solutions, to verify coverage of Kogenate FS and find out if you're eligible for co-pay assistance.*

Bayer Access Solutions logo

CALL
1-800-288-8374
NOW!

8:00 AM–8:00 PM (ET)
Monday–Friday

Spanish-speaking Case Specialists are also available.

*Some restrictions may apply. Please visit kogenate.com or call 1-800-288-8374 for more information about the restrictions.

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2.See the features of the Kogenate FS reconstitution system1:

Vial Adapter with built-in 15-micrometer filter

2.5 mL or 5.0 mL prefilled diluent syringe

25-gauge butterfly needle

Identical vial sizes as those offered with Helixate FS:

250 IU 2000 IU
500 IU 3000 IU
1000 IU

Watch the Vial Adapter in action

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3.Talk to your doctor to see if Kogenate FS may be appropriate for you.

Talk to your healthcare provider about your Factor VIII treatment

Visit the links below for additional resources on Kogenate FS:

Learn more about Kogenate FS

Meet your local Bayer Rep

Register for updates

Indications

Kogenate® FS Antihemophilic Factor (Recombinant) and Helixate® FS Antihemophilic Factor (Recombinant) are medicines used to replace clotting factor (factor VIII or antihemophilic factor) that is missing in people with hemophilia A.

Kogenate FS and Helixate FS are used to treat and control bleeding in adults and children with hemophilia A. Your healthcare provider may give you Kogenate FS or Helixate FS when you have surgery. Kogenate FS and Helixate FS can reduce the number of bleeding episodes in adults and children when used regularly (prophylaxis). Kogenate FS and Helixate FS can reduce the risk of joint damage in children without pre-existing joint damage when used regularly.

Kogenate FS and Helixate FS are not used to treat von Willebrand disease.

Important Safety Information

You should not use Kogenate FS or Helixate FS if you are allergic to rodents (like mice and hamsters) or are allergic to any ingredients in Kogenate FS or Helixate 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 or Helixate 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 or Helixate FS, which may stop Kogenate FS or Helixate 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 and Helixate 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 or Helixate FS.

For important risk and use information, please see the full Prescribing Information for Kogenate FS and Helixate FS.

You are encouraged to report negative side effects or quality complaints of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

Reference: 1. Kogenate FS with Vial Adapter [prescribing information]. Whippany, NJ: Bayer HealthCare LLC; 2016.