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SELECTED IMPORTANT SAFETY INFORMATION
FOR KOVALTRY®, Antihemophilic Factor (Recombinant)
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You should not use KOVALTRY® if you are allergic to rodents (like mice and hamsters) or any ingredients in KOVALTRY®. Continue reading below
SELECTED IMPORTANT SAFETY INFORMATION FOR HELIXATE® FS, Antihemophilic Factor (Recombinant)
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You should not use Helixate® FS if you are allergic to rodents (like mice and hamsters) or are allergic to any ingredients in Helixate® FS. Continue reading below
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Dear {{accTitle}} {{accFname}} {{accLname}},
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{{customText[I just wanted to follow up with you. You mentioned that you wanted to know more about the upcoming changes for Helixate FS and KOVALTRY. I wanted to send that information along.|It was great seeing you recently. I would like to share some additional information about Helixate FS and KOVALTRY that may be useful to you.|It was great seeing you recently. You said you had some questions about Helixate FS and KOVALTRY. I think you'll find this information useful.|I hope you are having a great day. I am following up on our previous conversation with the information you requested about Helixate FS and KOVALTRY.|It was great seeing you at the NHF meeting. I would like to share some additional information about Helixate FS and KOVALTRY.|It was great seeing you at the HFA meeting. I would like to share some additional information about Helixate FS and KOVALTRY.|It was great seeing you at the Texas Bleeds meeting. I would like to share some additional information about Helixate FS and KOVALTRY.|It was great seeing you at the FAM Ohio meeting. I would like to share some additional information about Helixate FS and KOVALTRY.]}}
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Because you or your loved one take Helixate® FS
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There are some important facts you should know about an upcoming change in the availability of Helixate® FS.
Important facts about Helixate® FS
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Under a current supply agreement, Bayer manufactures all Helixate® FS and provides it to CSL Behring |
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This supply agreement between Bayer and CSL Behring will end after December 31, 2017, at which point Helixate® FS will no longer be manufactured by Bayer |
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Consider transitioning to KOVALTRY®, which is based on the same primary protein structure as Helixate® FS
Bayer has been committed to the treatment of hemophilia A for over 20 years and will continue to offer a family of treatments, including KOVALTRY®
KOVALTRY®
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Is an unmodified, full length rFVIII |
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Is designed to closely match your body's natural FVIII |
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Uses 20-nm filtration, and no human- or animal-derived raw materials are added in the cell culture, purification, or formulation processes |
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Is covered by all major national insurance companies |
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Learn more about what KOVALTRY® has to offer you> |
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Sign up to receive the latest updates on KOVALTRY®, as well as information and resources about hemophilia A |
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Talk with your doctor to see if transitioning to KOVALTRY® is right for you
FVIII=Factor VIII.
rFVIII=recombinant Factor VIII.
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| INDICATIONS FOR KOVALTRY® |
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KOVALTRY® is a medicine used to replace clotting factor (Factor VIII or antihemophilic factor) that is missing in people with hemophilia A. |
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KOVALTRY® is used to treat and control bleeding in adults and children with hemophilia A. KOVALTRY® can reduce the number of bleeding episodes in adults and children with hemophilia A when used regularly (prophylaxis). Your healthcare provider may give you KOVALTRY® when you have surgery. |
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KOVALTRY® is not used to treat von Willebrand Disease. |
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| IMPORTANT SAFETY INFORMATION FOR KOVALTRY® |
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You should not use KOVALTRY® if you are allergic to rodents (like mice and hamsters) or any ingredients in KOVALTRY®. |
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Tell your healthcare provider if you have heart disease or are at risk for heart disease. |
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The common side effects of KOVALTRY® are headache, fever, and itchy rash. |
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Allergic reactions may occur with KOVALTRY®. Call your healthcare provider right away and stop treatment if you get tightness of the chest or throat, dizziness, decrease in blood pressure, and nausea. |
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Your body can also make antibodies, called "inhibitors," against KOVALTRY®, which may stop KOVALTRY® from working properly. Consult with your healthcare provider to make sure you are carefully monitored with blood tests for the development of inhibitors to Factor VIII. |
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Tell your healthcare provider about any side effect that bothers you or that does not go away. |
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Call your healthcare provider right away if bleeding is not controlled after using KOVALTRY®. |
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| INDICATIONS FOR HELIXATE® FS |
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Helixate® FS Antihemophilic Factor (Recombinant) is a medicine used to replace clotting factor (factor VIII or antihemophilic factor) that is missing in people with hemophilia A. |
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Helixate® FS is used to treat and control bleeding in adults and children with hemophilia A. Your healthcare provider may give you Helixate® FS when you have surgery. Helixate® FS can reduce the number of bleeding episodes in adults and children when used regularly (prophylaxis). Helixate® FS can reduce the risk of joint damage in children without pre-existing joint damage when used regularly. |
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Helixate® FS is not used to treat von Willebrand disease. |
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| IMPORTANT SAFETY INFORMATION FOR HELIXATE® FS |
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You should not use Helixate® FS if you are allergic to rodents (like mice and hamsters) or are allergic to any ingredients in Helixate® FS. |
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Tell your healthcare provider if you have been told you have heart disease or are at risk for heart disease. |
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You could have an allergic reaction to Helixate® FS. Call your healthcare provider right away and stop treatment if you get rash or hives, itching, tightness of the chest or throat, difficulty breathing, light-headed, dizziness, nausea or a decrease in blood pressure. |
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Your body can make antibodies, called "inhibitors," against Helixate® FS, which may stop Helixate® FS from working properly. Consult with your healthcare provider to make sure you are carefully monitored with blood tests for the development of inhibitors to factor VIII. |
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Other common side effects of Helixate® FS are local injection site reactions (pain, swelling, irritation at infusion site) and infections from implanted injection device. Tell your healthcare provider about any side effect that bothers you or does not go away. |
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Call your healthcare provider right away if bleeding is not controlled after using Helixate® FS. |
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For additional important risk and use information, please see full Prescribing Information for KOVALTRY® and Helixate® FS.
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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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{{customText[If you have any questions on Bayer support services, feel free to reply to this email or give me a call.|I hope this information helps. Please don't hesitate to call or email me if you are interested in more information or have any questions.|If you have any questions about KOVALTRY, I would be happy to talk with you. Feel free to contact me at the number below or reply to this email.]}}
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Sincerely,
{{userName}}
{{User.Phone}}
Bayer Hematology
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| Reference: KOVALTRY® [prescribing information]. Whippany, NJ: Bayer HealthCare LLC; 2016.
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Bayer, the Bayer Cross, and KOVALTRY are registered trademarks of Bayer.
Helixate FS is a registered trademark of CSL Behring LLC.
| © 2017 Bayer. |
All rights reserved. |
08/17 |
PP-675-US-1101 |
If you would like to contact us, please visit our Contact Us section online.
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