Kogenate(R) FS BAYER

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
 
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The Kogenate FS Free Trial Program* can help introduce your hemophilia A patients to treatment with Kogenate FS. Enrollment in the program is fast and simple.
   
• Offers up to 6 free doses to a maximum of 5,000 IU for people who are newly diagnosed and 40,000 IU for people who have previously been treated
   
• Delivered directly to the selected destination
   
• No obligation to purchase Kogenate FS before or after participating in the Free Trial Program
 
For more information on the Kogenate FS Free Trial Program, please call 1-866-329-3449 Monday through Friday, 8:30 AM to 5:30 PM ET, or visit www.kogenatefs.com
 

 
 
* The Kogenate FS Free Trial Program is available to newly diagnosed patients and patients who are currently using other FVIII therapy. Patients currently using Kogenate FS are not eligible for the Free Trial Program. Participation in the Kogenate FS Free Trial Program is limited to 1 time only. The medication provided through this program is complimentary and is not an obligation to purchase or use Kogenate FS in the future. Reselling or billing any third party for the free product is prohibited by law.
 
For your patients with hemophilia A, Kogenate FS offers:
   
• Joint protection with routine prophylaxis in children with no pre-existing joint damage1
   
• On-demand treatment for active bleeds in adults and children1

Click here for a look at the data.
 
 
INDICATIONS
   
• Kogenate® FS antihemophilic factor (recombinant) is a recombinant factor VIII indicated for:
   
  • Control and prevention of bleeding episodes in adults and children with hemophilia A.
   
  • Surgical prophylaxis in adults and children with hemophilia A.
   
  • Routine prophylactic treatment to prevent or 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 prophylactic treatment to prevent or 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.
 
{{customText[I would be glad to provide further information to help you and your hemophilia A patients with their Kogenate FS treatment. If you’d like to speak more, please feel free to contact me at the number below. | Since we haven’t met in a while, I would welcome the opportunity to talk with you in person about this information. If you’re interested, please feel free to contact me at the number below. | Thank you for reviewing this information on Kogenate FS. I hope it was helpful. Please don’t hesitate to call me if you have any questions about the information provided, or if you need additional materials. | Since you requested this information, I want to answer any questions you may have. Please don’t hesitate to call me if there is anything else I can help with. | If you have any questions, I would be happy to speak further, or to set up a visit at your convenience.]}}
 
 
 
Sincerely,
 
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Bayer Hematology
 
 
 
 
Reference: 1. Kogenate FS with Vial Adapter [package insert]. Whippany, NJ: Bayer HealthCare LLC; 2014.
 
 
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