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FVIII treatment update
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SELECTED IMPORTANT SAFETY INFORMATION FOR KOVALTRY®, Antihemophilic Factor (Recombinant)
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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
SELECTED IMPORTANT SAFETY INFORMATION FOR HELIXATE® FS, Antihemophilic Factor (Recombinant)
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Helixate® FS 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}},
{{customText[
1. Thank you for taking time to meet with me to discuss Helixate FS and KOVALTRY. You requested some information and I wanted to follow up with some relevant materials.
2. I'm sorry we missed each other when I stopped by your office. I have some information about Helixate FS and KOVALTRY that I would like to share with you.
3. It's been a while since our last meeting, so I wanted to share some information about Helixate FS and KOVALTRY that you might find interesting.
4. Hello, I'm a Bayer Representative. I would like to share some information with you about Helixate FS and KOVALTRY that may be useful for you and your patients with hemophilia A.
5. Although we have not yet had the opportunity to meet in person, I wanted to send you some relevant information about Helixate FS and KOVALTRY for your patients with hemophilia A.
6. It was great to see you recently at the NHF meeting. I wanted to share some information about Helixate FS and KOVALTRY that you might find interesting.
7. It was great to see you recently at the HFA meeting. I wanted to share some information about Helixate FS and KOVALTRY that you might find interesting.
8. It was great to see you recently at the chapter meeting. I wanted to share some information about Helixate FS and KOVALTRY that you might find interesting.
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10. It was great to see you recently at the meeting. I wanted to share some information that you might find interesting about Helixate FS and KOVALTRY.
]}}
Recently there have been changes announced regarding Factor VIII treatment that will affect the hemophilia A community.
As you may already know, under a current supply agreement, Bayer manufactures Helixate® FS and provides it to CSL Behring. However, this supply agreement between Bayer and CSL Behring is ending after December 31, 2017, at which point Helixate® FS will no longer be manufactured by Bayer.
For your patients on Helixate® FS, consider transitioning them to KOVALTRY®
Bayer has been committed to the treatment of hemophilia A for over 20 years and will continue to offer 2 treatments, one of which is KOVALTRY®. KOVALTRY® has the same primary protein structure as Helixate® FS.
| KOVALTRY® |
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Is an unmodified, full length rFVIII
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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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Offers the potential for 2x/week dosing. Recommended dosing for KOVALTRY®:
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For children ≤12 years of age: 25–50 IU/kg 2x/week, 3x/week, or every other day
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For adolescents and adults: 20–40 IU/kg 2x/week or 3x/week
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Is covered by all major national insurance companies
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Includes Express Scripts, CVS/Caremark, OptumRx, Prime Therapeutics, Magellan, Aetna, Humana, UnitedHealthcare, Anthem, and Cigna
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| Coverage questions about KOVALTRY®? |
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Bayer Access Solutions offers insurance, financial support, and trained Case Specialists to allow for a seamless transition*
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Loyalty Program†: Patients can redeem points to receive KOVALTRY® at no cost if they experience gaps or challenges with insurance coverage
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You and your patients can call 1-800-288-8374, 8:00 AM–8:00 PM (ET) Monday through Friday to learn more or enroll
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Restrictions apply. Please click here or call 1-800-288-8374 for more information about the restrictions.
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Patients who have government insurance are not eligible for the loyalty and co-pay support programs.
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| INDICATIONS FOR KOVALTRY® |
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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 FOR KOVALTRY® |
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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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| INDICATIONS FOR HELIXATE® FS |
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Helixate® 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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Helixate® FS is not indicated for the treatment of von Willebrand disease.
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| IMPORTANT SAFETY INFORMATION FOR HELIXATE® FS |
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Helixate® FS 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 Helixate® 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 Helixate® FS if symptoms occur and seek immediate emergency treatment.
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Neutralizing antibodies (inhibitors) have been reported following administration of Helixate® 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 Helixate® 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 important risk and use information, please see full Prescribing Information for KOVALTRY® and Helixate® FS.
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[
1. I would be glad to provide further information to help you and your patients with hemophilia A with their KOVALTRY treatment. If you'd like to speak more, please feel free to contact me at the number below.
2. 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.
3. Thank you for reviewing this information about 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.
4. 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.
5. 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
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-1076
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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