Kogenate(R) FS Antihemophilic Factor (Recombinant)   BAYER

SELECTED IMPORTANT SAFETY INFORMATION
Kogenate® FS Antihemophilic Factor (Recombinant) is contraindicated in patients who have life-threatening hypersensitivity reactions, including anaphylaxis to mouse or hamster protein or other constituents of the product. Continue reading below
 
Dear {{accTitle}} {{accFname}} {{accLname}},
 
{{customText[It was nice speaking with you recently. As a follow-up to our discussion, I am reaching out to inform you of an upcoming opportunity to learn more about the treatment of hemophilia A.|Thank you for attending our recent educational information session. As a follow-up to that program, I would like to invite you to attend an additional program that may be useful to you and your practice in the treatment of hemophilia A.|As your dedicated Clinical Support Specialist, I am pleased to invite you to attend an educational information session about the treatment of hemophilia A.]}}

Bayer is presenting the program "Treatment of Hemophilia A." This program will provide a broad overview of hemophilia A treatment methods and strategies, from a healthcare provider perspective. It will cover the role of the hemophilia treatment center (HTC), the use of prophylaxis and on-demand treatment, and the potential barriers to compliance.

This program will also provide information on treatment with Kogenate® FS, Antihemophilic Factor (Recombinant). Kogenate® FS is indicated for routine prophylaxis to reduce the frequency of bleeding episodes in adults with hemophilia A. It is also indicated for 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. The program will cover dosing for Kogenate® FS, and present the results of two major clinical trials—SPINART (Secondary Prophylaxis in Adults: A Randomized Trial) and JOS (Joint Outcome Study).

I hope to see you at this educational information session. Please see below for additional details.
 
Date: {{customText(50)}}

Time: {{customText(50)}}

Location: {{customText(255)}}

Speaker: {{customText[Judy Kauffman, RN, MS, CPNP|Angela Lambing, MSN, ANPC, GNPC|Linda Peacock, RN, BSN, MBA|Jennifer Harris, RN, BSN|Joni Osip, APRN, CNP|Jessica Walker, RN, BSN]}}
 
To confirm your participation in this program, please reply directly to this email.
 
  
   
INDICATIONS
   
■ Kogenate® FS is an Antihemophilic Factor (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 is not indicated for the treatment of von Willebrand disease.
 
IMPORTANT SAFETY INFORMATION
■ Kogenate FS Antihemophilic Factor (Recombinant) is contraindicated in patients who have life-threatening hypersensitivity reactions, including anaphylaxis to mouse or hamster protein or other constituents of the product.
 
■ Hypersensitivity reactions, including anaphylaxis have been reported with Kogenate 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 if symptoms occur and seek immediate emergency treatment.
 
■ Neutralizing antibodies (inhibitors) have been reported following administration of Kogenate 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 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 click here for full Prescribing Information.

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.

Regards,
 
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Bayer Clinical Support Specialist
 
 
Kogenate(R) FS Antihemophilic Factor (Recombinant) BAYER
 
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