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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. Continue reading below
Dear {{accTitle}} {{accFname}} {{accLname}},
{{customText[ Thank you for taking time to meet with me to discuss KOVALTRY®. You requested some information about KOVALTRY®, and I wanted to follow up with some relevant materials. | I'm sorry we missed each other when I stopped by your office. I have some information about KOVALTRY® I would like to share with you. | It's been a while since our last meeting, so I wanted to share some information you might find interesting about KOVALTRY®. | Hello, I'm a Bayer Representative. I would like to share some information with you about KOVALTRY® that may be useful for you and your hemophilia A patients. | Although we have not yet had the opportunity to meet in person, I wanted to send you some relevant information about KOVALTRY® for your hemophilia A patients. | It was great to see you recently at the NHF meeting. I wanted to share some information you might find interesting about KOVALTRY®. | It was great to see you recently at the HFA meeting. I wanted to share some information you might find interesting about KOVALTRY®. | It was great to see you recently at the chapter meeting. I wanted to share some information you might find interesting about KOVALTRY®. | It was great to see you recently at the community event. I wanted to share some information you might find interesting about KOVALTRY®. | It was great to see you recently at the meeting. I wanted to share some information you might find interesting about KOVALTRY®.]}}
Reimbursement Support, Coverage, and Financial Solutions
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Free Trial Program✱: Talk to your patients about requesting a free trial of KOVALTRY® with Vial Adapter
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Patient Access to Therapy: Patients may be able to receive KOVALTRY® at no cost if they experience challenges getting insurance coverage for KOVALTRY®†
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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 1-800-288-8374 for answers to any insurance coverage questions†
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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 additional important risk and use information, click here for 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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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 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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{{customText[ I would be glad to provide further information to help you and your hemophilia A patients with their KOVALTRY® 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 KOVALTRY®. 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,
{{userName}}
{{User.Phone}}
Bayer Hematology
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Bayer, the Bayer Cross, and KOVALTRY are registered trademarks of Bayer.
© 2016 Bayer. All rights reserved. 03/16 PP-675-US-0284
Please note: this e-mail is not monitored for replies. If you would like to contact us, please visit our Contact Us section online.
100 Bayer Boulevard, PO Box 915, Whippany, NJ 07981-0915 USA
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