For patients on
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
1.Connect with Bayer Access Solutions, to verify coverage of Kogenate FS and find out if you're eligible for co-pay assistance.*
8:00 AM–8:00 PM (ET)
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.
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|
Watch the Vial Adapter in action
Please see full Prescribing Information for Kogenate FS.
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.
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.