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SELECTED IMPORTANT SAFETY INFORMATION |
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KOVALTRY® Antihemophilic Factor (Recombinant) is contraindicated in patients who have a history of hypersensitivity reactions to the active substance, to any of the excipients, or to mouse or hamster proteins. Continue reading below |
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Bayer Access Solutions: Reimbursement Support, Coverage, and Financial Solutions |
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| KOVALTRY® Free Trial Program* |
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Patients can receive up to 6 free doses† |
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KOVALTRY® is delivered to your patient's home |
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Any patient who has not experienced KOVALTRY® is able to participate, regardless of type of insurance or if you have insurance |
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| Access to Therapy |
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| Concerned about your patients maintaining access to treatment? |
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| We might be able to provide KOVALTRY® at no cost to your patients if they are‡: |
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Experiencing challenges getting coverage for KOVALTRY® |
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Uninsured or underinsured |
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Between jobs and experiencing a gap between insurance coverage |
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| $0 Co-pay Program§ |
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| If your patients have private insurance, they may be eligible for the $0 Co-pay Program. |
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Eligible patients may receive up to $12,000 in assistance per year, regardless of income |
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Assistance is awarded per patient. Multiple members of the same household can apply |
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Enrollment can be started and completed in one short phone call |
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Live Helpline Support |
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Consult with an expert in insurance |
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Multiple languages, including Spanish, are spoken |
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| CALL 1-800-288-8374! |
| 8:00 AM–8:00 PM (ET) Monday–Friday |
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INDICATIONS |
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KOVALTRY® Antihemophilic Factor (Recombinant) is a recombinant human DNA sequence derived, full length Factor VIII concentrate indicated for use in adults and children with hemophilia A for: |
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On-demand treatment and control of bleeding episodes |
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Perioperative management of bleeding |
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Routine prophylaxis to reduce the frequency of bleeding episodes |
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KOVALTRY® is not indicated for the treatment of von Willebrand disease. |
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IMPORTANT SAFETY INFORMATION |
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KOVALTRY® is contraindicated in patients who have a history of hypersensitivity reactions to the active substance, to any of the excipients, or to mouse or hamster proteins. |
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Hypersensitivity reactions, including anaphylaxis, are possible with KOVALTRY®. Early signs of hypersensitivity reactions, which can progress to anaphylaxis, may include chest or throat tightness, dizziness, mild hypotension and nausea. Discontinue KOVALTRY® if symptoms occur and seek immediate emergency treatment. |
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KOVALTRY® may contain trace amounts of mouse and hamster proteins. Patients treated with this product may develop hypersensitivity to these non-human mammalian proteins. |
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Neutralizing antibody (inhibitor) formation can occur following administration of KOVALTRY®. Previously untreated patients (PUPs) are at greatest risk for inhibitor development with all Factor VIII products. 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 as expected with administered dose, suspect the presence of an inhibitor. |
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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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Catheter-related infections may occur when KOVALTRY® is administered via central venous access devices (CVADs). These infections have not been associated with the product itself. |
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The most frequently reported adverse reactions in clinical trials (≥3%) were headache, pyrexia, and pruritus. |
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For important risk and use information, please click here for full Prescribing Information. |
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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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The KOVALTRY® Free Trial Program is available to newly diagnosed patients and patients who are currently using other therapy. Patients currently using KOVALTRY® are not eligible for the Free Trial Program. Participation in the KOVALTRY® 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 KOVALTRY® in the future. Reselling or billing any third party for the free product is prohibited by law. |
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The KOVALTRY® Free Trial Program includes up to 6 free doses to a maximum of 5,000 IU for new patients and 40,000 IU for previously treated patients. |
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The program does not guarantee that patients will be successful in obtaining reimbursement. Support medication provided through Bayer's assistance programs is complimentary and is not contingent on future KOVALTRY® purchases. Reselling or billing any third party for free product provided by Bayer's patient assistance programs is prohibited by law. Bayer reserves the right to determine eligibility, monitor participation, determine equitable distribution of product, and modify or discontinue the program at any time. |
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People with private, commercial health insurance may receive KOVALTRY® 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 discontinue the program at any time. |
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Bayer, the Bayer Cross, and KOVALTRY are registered trademarks of Bayer. © 2017 Bayer. All rights reserved. 03/17 PP-675-US-0772 |
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Please note: this e-mail is not monitored for replies. If you would like to contact us, please visit our Contact Us section online. |
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