FVIII treatment update

IMPORTANT SAFETY INFORMATION Kogenate^® FS, Antihemophilic Factor (Recombinant) and Helixate^® FS, Antihemophilic Factor (Recombinant) are contraindicated in patients who have life-threatening hypersensitivity reactions, including anaphylaxis to mouse or hamster protein or other consituents of the products. Continue reading below

Dear Healthcare Professional,

Since Kogenate FS contains the same factor (active pharmaceutical ingredient and formulation) as Helixate FS, it presents a proven option for your Helixate FS patients who are looking to stay on their factor. This email contains specific information that you may find helpful as you transition your Helixate FS patients to Kogenate FS.

As you may already know, under a current supply agreement, Bayer manufactures Helixate FS and provides it to CSL Behring to market and distribute. However, this supply agreement between Bayer and CSL Behring will end after Dec‍ember 31‍, 201‍7, at which point Helixate FS will no longer be manufactured by Bayer.

For your patients on Helixate FS, they can continue FVIII treatment with Kogenate FS

Kogenate FS was prescribed for 7 out of 10 patients who have transitioned from Helixate FS*

Some important information to know when considering this transition

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

■	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 and is preferred by CVS/Caremark,^† Express Scripts,^‡ and UnitedHealthcare^†

We recognize that a change in treatment can be difficult for patients and may take some time, and that patients may have questions regarding these changes.

Bayer is committed to supporting the hemophilia A community with a variety of patient and community support programs.

Your Bayer Representative can provide you with cover letters and educational materials about Kogenate FS to send to your Helixate FS patients to help with the transition. To contact your Bayer Representative to request these materials, please click here.

Coverage questions about Kogenate FS?

■	Bayer Access Solutions^§ offers insurance, financial support, and trained Case Specialists to allow for a seamless transition

■	Loyalty Program^\|\|: Can assist patients during gaps in insurance coverage. Patients who enroll today will receive a bonus of 12 points

■	You or your patients can call 1-800-288-8374 8‍:‍00 AM‍–‍8‍:‍00 PM (ET) Mon‍day‍–‍Fri‍day for more information or to enroll

Your patients can learn more at
ContinueFactor.com

*	Sources: Symphony Health claim database; specialty pharmacy aggregate data; 1/‍17 ‍–‍ 5‍/1‍7. Percentage is derived from actual data from an existing data set, which may underestimate or overestimate actual percentage.
^†	On some commercial prescription plans.
^‡	This pertains to Express Scripts's National Preferred and Basic Formularies.
^§	Restrictions apply. Please call 1-800-288-8374 for more information about the restrictions.
^\|\|	Patients who have government insurance are not eligible for the loyalty and co-pay support programs.

INDICATIONS

■	Kogenate^® FS and Helixate^® FS are Antihemophilic Factors (Recombinant) indicated for:

	■	On-demand treatment and control of bleeding episodes in adults and children with hemophilia A.

	■	Perioperative management of bleeding in adults and children with hemophilia A.

	■	Routine prophylaxis to reduce the frequency of bleeding episodes in children with hemophilia A and to reduce the risk of joint damage in children without pre-existing joint damage.

	■	Routine prophylaxis to reduce the frequency of bleeding episodes in adults with hemophilia A.

■	Kogenate FS and Helixate FS are not indicated for the treatment of von Willebrand disease.

IMPORTANT SAFETY INFORMATION


■	Kogenate FS and Helixate FS Antihemophilic Factors (Recombinant) are contraindicated in patients who have life-threatening hypersensitivity reactions, including anaphylaxis to mouse or hamster protein or other constituents of the products.

■	Hypersensitivity reactions, including anaphylaxis have been reported with Kogenate FS and Helixate FS. Reported symptoms included facial swelling, flushing, hives, decrease in blood pressure, nausea, rash, restlessness, shortness of breath, tachycardia, tightness of the chest, tingling, urticaria, and vomiting. Discontinue Kogenate FS or Helixate FS if symptoms occur and seek immediate emergency treatment.

■	Neutralizing antibodies (inhibitors) have been reported following administration of Kogenate FS and Helixate FS predominately in previously untreated patients. Carefully monitor patients for the development of factor VIII inhibitors, using appropriate clinical observations and laboratory tests. If expected plasma factor VIII activity levels are not attained, or if bleeding is not controlled with an expected dose, perform an assay that measures factor VIII inhibitor concentration.

■	Hemophilic patients with cardiovascular risk factors or diseases may be at the same risk to develop cardiovascular events as non-hemophilic patients when clotting has been normalized by treatment with factor VIII.

■	Serious adverse reactions seen with Kogenate FS and Helixate FS are systemic hypersensitivity reactions including bronchospastic reactions and/or hypotension and anaphylaxis, and the development of high-titer inhibitors necessitating alternative treatments to factor VIII.

■	The most common adverse reactions (≥4%) observed in clinical trials were inhibitor formation in previously untreated and minimally treated patients, skin-related hypersensitivity reactions, infusion site reactions, and central venous access device (CVAD) associated infections.

For additional important risk and use information, please see 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.

If you have any questions about Kogenate FS, you can reach out to your Bayer Representative.

Bayer, the Bayer Cross, and Kogenate are registered trademarks of Bayer.
Helixate FS is a registered trademark of CSL Behring LLC.

08/17

PP-575-US-2907