See the results for KOVALTRY® Antihemophilic Factor (Recombinant)               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® Give him the opportunity to explore the possibilities           • KOVALTRY® is an unmodified, full-length recombinant Factor VIII manufactured using state-of-the-art techniques1     • Heat shock protein 70 (HSP70) to help ensure proper FVIII folding1     • No human- or animal-derived raw materials are added to the cell culture, purification, or formulation processes1     • 20-nanometer filtration step designed to remove potential small viruses1   • KOVALTRY® has proven efficacy and safety in adolescents and adults with prophylaxis using as few as 2 infusions per week1   • KOVALTRY® continues Bayer's more than 20 years of commitment to the hemophilia A community         Explore what's possible for your patients—see the results of the LEOPOLD I trial >         Find your local Bayer Representative >       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, 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.       Reference: 1. KOVALTRY® [prescribing information]. Whippany, NJ: Bayer HealthCare LLC; 2016           Bayer, the Bayer Cross, and KOVALTRY are registered trademarks of Bayer. © 2016 Bayer.       All rights reserved.       0‌7/16       PP-675-US-0450   Please note: this e-mail is not monitored for replies. If you would like to contact us, please visit our Contact Us section online.