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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}},
To learn more about Bayer Access Solutions programs, you and your patients with hemophilia A can call the Live Helpline at
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Dedicated Case Specialists are available to provide support, and to help answer your and your patients' questions. Spanish-speaking Case Specialists are also available.
Bayer Access Solutions offers a variety of programs that can help you assist your patients.
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Bayer Access Solutions programs include all of the following:
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$0 Co-pay Program*: Eligible patients can receive up to $12,000 in assistance per year
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Live Helpline Support: Patients can call for answers to any insurance coverage questions†
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Free Trial Program‡: Talk to your patients about requesting a free trial of Kogenate FS with Vial Adapter
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If you'd like to learn more, please contact your Bayer Representative.
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| INDICATIONS |
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Kogenate® FS is an Antihemophilic Factor (Recombinant) indicated for:
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On-demand treatment and control of bleeding episodes in adults and children with hemophilia A.
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Perioperative management of bleeding in adults and children with hemophilia A.
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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.
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Routine prophylaxis to 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 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.
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People with private, commercial health insurance may receive Kogenate FS co-pay or co-insurance assistance based on eligibility requirements. The program is on a first-come, first-served basis. Financial support is available for up to 12 months. Eligible patients can re-enroll for additional 12-month courses. The program is not for patients receiving prescription reimbursement under any federal-, state-, or government-funded insurance programs, or where prohibited by law. All people who meet these criteria are encouraged to apply. Bayer reserves the right to determine eligibility, monitor participation, determine equitable distribution of product, and modify or discontinue the $0 Co-pay Program at any time.
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The Bayer Reimbursement Helpline does not guarantee that patients will be successful in obtaining reimbursement. The support medication provided through Bayer's assistance programs is complimentary and it is not contingent on future Kogenate FS purchases. Reselling or billing any third-party payer for free product provided by Bayer's assistance programs is prohibited by law. Bayer reserves the right to modify, change, or terminate any of the Bayer Access Solutions programs. Additional terms and conditions apply.
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The Kogenate FS Free Trial Program is available to newly diagnosed patients and patients who are currently using other 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.
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Bayer, the Bayer Cross, and Kogenate are registered trademarks of Bayer.
© 2017 Bayer. All rights reserved. 03/17 PP-575-US-2855
Please note: this email is not monitored for replies. If you would like to contact us, please visit our Contact Us section online.
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