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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 [Insert Name],
Kogenate® FS is available with the Vial Adapter reconstitution system. Vial Adapter is a needleless reconstitution system that contains a sterile vial adapter with a built-in 15-micrometer filter and a prefilled diluent syringe.1
For your patients with hemophilia A, Kogenate FS offers:
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Routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adults1
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Joint protection with routine prophylaxis in children (0-16 years) with no pre-existing joint damage1
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On-demand treatment for active bleeds in adults and children1
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To take a closer look at the data, visit kogenatefs.com
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For the efficacy your patients with hemophilia A need, consider Kogenate FS antihemophilic factor (recombinant)
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INDICATIONS
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Kogenate® FS antihemophilic factor (recombinant) is a recombinant factor VIII treatment indicated for:
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Control and prevention of bleeding episodes in adults and children with hemophilia A.
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Surgical prophylaxis in adults and children with hemophilia A.
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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.
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Routine prophylactic treatment to prevent or reduce the frequency of bleeding episodes in adults with hemophilia A.
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Kogenate FS is not indicated for the treatment of von Willebrand disease.
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IMPORTANT SAFETY INFORMATION
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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.
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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.
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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.
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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.
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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.
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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.
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For important risk and use information, please click here for the full Prescribing Information.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.
Please note this email is not monitored. If you would like to contact us, please visit our website.
Reference: 1. Kogenate® FS with Vial Adapter [package insert]. Tarrytown, NY: Bayer HealthCare LLC; 2014.
Bayer, the Bayer Cross, and Kogenate are registered trademarks of Bayer.
© 2014 Bayer HealthCare Pharmaceuticals Inc. All rights reserved. 7/14 KN56005514
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