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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 {{accTitle}} {{accFname}} {{accLname}},
At Bayer, we recognize that changes in healthcare law can raise new concerns about insurance coverage. We are dedicated to helping find answers to the questions that may arise.
Bayer’s Factor Solutions offers assistance to help you and your patients navigate difficult insurance issues and find potential sources of financial assistance. Trained case specialists are available to help; call 1-800-288-8374 from 8:30 AM to 5:30 PM (ET), Monday through Friday. Spanish-speaking case specialists are also available.
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Factor Solutions can also help patients enroll in the $0 Co-pay Program. With this program, eligible patients can be covered for up to $12,000 in co-pay assistance for their Kogenate FS therapy, regardless of income.†
Connect with a Factor Solutions case specialist today: call 1-800-288-8374 or visit factorsolutionssupport.com.
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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 with no pre-existing joint damage1
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On-demand treatment for active bleeds in adults and children1
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For a closer look at the data, visit kogenatefs.com.
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The reimbursement helpline does not guarantee your patients will be successful in obtaining reimbursement.
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†
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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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INDICATIONS
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Kogenate® FS antihemophilic factor (recombinant) is a recombinant factor VIII 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 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.
Reference: 1.Kogenate® FS with Vial Adapter {package insert}. Whippany, NJ: Bayer HealthCare LLC; 2014.
Bayer, the Bayer Cross, and Kogenate are registered trademarks of Bayer.
© 2014 Bayer HealthCare Pharmaceuticals Inc. All rights reserved. 9/14 PP-575-USD-1210
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