View Kogenate® FS Antihemophilic Factor (Recombinant) with Vial Adapter               IMPORTANT SAFETY INFORMATION Kogenate® FS Antihemophilic Factor (Recombinant) 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 [Insert Name],   Kogenate FS is available with the Vial Adapter reconstitution system. Vial Adapter is a needleless reconstitution system that contains a sterile vial adapter with a built-in 15-micrometer filter.   The Kogenate FS needleless reconstitution system contains:   1. Product vial   2. Prefilled diluent syringe and separate plunger rod   3. Vial Adapter with built-in filter   4. Butterfly needle administration set       Kogenate FS can be stored at room temperature (up to 77°F for up to 1 year)           Store Kogenate FS at 36°F to 46°F for up to 30 months from the date of manufacture. Do not freeze. Within this period, Kogenate FS may be stored for a single period of up to 12 months at temperatures up to 77°F. Record the starting date of room-temperature storage on the unopened product carton. Once stored at room temperature, do not return the product to the refrigerator. The shelf-life then expires after storage at room temperature for 12 months or after the expiration date on the product vial, whichever is earlier.       For your patients with hemophilia A, Kogenate FS offers:   ■ Routine prophylaxis to reduce the frequency of bleeding episodes in adults   ■ Routine prophylaxis in children with no pre-existing joint damage to help reduce the risk of joint damage   ■ On-demand treatment for active bleeds in adults and children           Consider Kogenate FS for your patients with hemophilia A.   Contact your Bayer Representative for more information.   INDICATIONS   ■ Kogenate® FS is an Antihemophilic Factor (Recombinant) indicated for:     ■ On-demand treatment and control of bleeding episodes in adults and children with hemophilia A.     ■ Perioperative management of bleeding in adults and children with hemophilia A.     ■ 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.     ■ Routine prophylaxis to reduce the frequency of bleeding episodes in adults with hemophilia A.   ■ Kogenate FS is not indicated for the treatment of von Willebrand disease.   IMPORTANT SAFETY INFORMATION   ■ Kogenate FS Antihemophilic Factor (Recombinant) is contraindicated in patients who have life-threatening hypersensitivity reactions, including anaphylaxis to mouse or hamster protein or other constituents of the product.   ■ Hypersensitivity reactions, including anaphylaxis have been reported with Kogenate 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 Kogenate FS if symptoms occur and seek immediate emergency treatment.   ■ Neutralizing antibodies (inhibitors) have been reported following administration of Kogenate 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.   ■ 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.   ■ Serious adverse reactions seen with Kogenate 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.   ■ 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.       For important risk and use information, please click here for the 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: Kogenate® FS with Vial Adapter [prescribing information]. Whippany, NJ: Bayer HealthCare LLC; 2016.   Bayer, the Bayer Cross, and Kogenate are registered trademarks of Bayer. © 2017 Bayer.   All rights reserved.   03/‌17   PP-575-US-2862   Please note this email is not monitored. If you would like to contact us, please visit our website.