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Permanent, unique KOVALTRY® J-Code: J7211
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SELECTED IMPORTANT SAFETY INFORMATION
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[I would like to share some information about KOVALTRY that you may find useful.|I wanted to follow up on some information I left with you recently.|Here is some additional information regarding our recent discussion.|Thank you for taking the time to meet with me to discuss KOVALTRY. I wanted to follow up with some relevant information.|I'm sorry we missed each other recently. 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.|Although we have not yet had the opportunity to meet in person, I wanted to send you some relevant information about KOVALTRY.|It was great to see you recently. I wanted to share some information you may find interesting about KOVALTRY.]}}
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KOVALTRY® has a permanent, unique J-code that can be used on or after January 1, 2018 to identify KOVALTRY® on healthcare claims forms. Be sure to share this J-Code with members of your staff responsible for billing and coding.
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Unique, permanent
KOVALTRY® J-Code:
J7211
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Healthcare Common Procedure Coding System (HCPCS) Code
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Description
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J7211
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Injection, factor viii, (antihemophilic factor, recombinant), (Kovaltry), 1 i.u.
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Vial Size and Diluent
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Billing NDC#
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250 IU; 2.5 mL diluent
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0026-3821-25
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500 IU; 2.5 mL diluent
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0026-3822-25
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1000 IU; 2.5 mL diluent
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0026-3824-25
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2000 IU; 5.0 mL diluent
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0026-3826-50
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3000 IU; 5.0 mL diluent
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0026-3828-50
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Bayer Access Solutions can provide your patients with information about reimbursement support, coverage, and financial solutions. For more information, click here or reach out to Bayer Access Solutions at 1‑800‑288‑8374 from 8:00 am-8:00 pm (ET) Monday to Friday.
For more information on ordering KOVALTRY®, click here.
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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, 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.
{{customText[I would be glad to provide further information to help you and your patients. If you'd like to speak more, please feel free to contact me at the number below or reply to this email.|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 or reply to this email.|Thank you for reviewing this information on KOVALTRY. I hope it was helpful. Please don't hesitate to call or email me if you have any questions about the information provided or if you need additional materials.|If you have any questions, I would be happy to speak further or 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.
© 2017 Bayer. All rights reserved. 12/17 PP‑675‑US‑1225
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