Permanent, unique KOVALTRY® J-Code: J7211       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       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.         Unique, permanent KOVALTRY® J-Code: J7211         Healthcare Common Procedure Coding System (HCPCS) Code     Description   J7211     Injection, factor viii, (antihemophilic factor, recombinant), (Kovaltry), 1 i.u.           Vial Size and Diluent     Billing NDC#   250 IU; 2.5 mL diluent     0026‌-‌3821‌-‌25     500 IU; 2.5 mL diluent     0026‌-‌3822‌-‌25     1000 IU; 2.5 mL diluent     0026‌-‌3824‌-‌25     2000 IU; 5.0 mL diluent     0026‌-‌3826‌-‌50     3000 IU; 5.0 mL diluent     0026‌-‌3828‌-‌50           Download the KOVALTRY Billing and Coding Guide, which contains additional information and resources, including NDCs and CPT Codes.       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.       INDICATIONS   • 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:     • On-demand treatment and control of bleeding episodes     • Perioperative management of bleeding     • Routine prophylaxis to reduce the frequency of bleeding episodes   • KOVALTRY® is not indicated for the treatment of von Willebrand disease.   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.   • 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.   • KOVALTRY® may contain trace amounts of mouse and hamster proteins. Patients treated with this product may develop hypersensitivity to these non-human mammalian proteins.   • 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.   • 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.   • 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.   • The most frequently reported adverse reactions in clinical trials (≥3%) were headache, pyrexia, and pruritus.       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.             Bayer, the Bayer Cross, and KOVALTRY are registered trademarks of Bayer. © 2017 Bayer.   All rights reserved.   12/‌17   PP‑675‑US‑1201       If you would like to contact us, please visit our Contact Us section online.