SELECTED 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 {{accTitle}} {{accFname}} {{accLname}},   {{customText[Thank you for taking time to meet with me to discuss Kogenate FS. You requested some information about Kogenate FS, and I wanted to follow up with some relevant materials. | I’m sorry we missed each other when I stopped by your office. I have some information about Kogenate FS 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 Kogenate FS. | Hello, I’m a Bayer HealthCare representative. I would like to share some information with you about Kogenate FS that may be useful for you and your hemophilia A patients. | Although we have not yet had the opportunity to meet in person, I wanted to send you some relevant information about Kogenate FS for your hemophilia A patients. | It was great to see you recently at the NHF meeting. I wanted to share some information you might find interesting about Kogenate FS. | It was great to see you recently at the HFA meeting. I wanted to share some information you might find interesting about Kogenate FS. | It was great to see you recently at the chapter meeting. I wanted to share some information you might find interesting about Kogenate FS. | It was great to see you recently at the community event. I wanted to share some information you might find interesting about Kogenate FS. | It was great to see you recently at the meeting. I wanted to share some information you might find interesting about Kogenate FS.]}}   As you are aware, Kogenate FS is a treatment for routine prophylaxis in children with hemophilia A and no pre-existing joint damage. In this population, Kogenate FS has been shown to reduce the frequency of bleeding episodes and the risk of joint damage.1,2 The Joint Outcome Study (JOS) demonstrated the effectiveness of Kogenate FS in children’s prophylaxis.1   Kogenate FS offers proven results for prophylaxis in children (0-16 years).                             93% (25 of 27) of children with no pre-existing joint damage treated with Kogenate or Kogenate FS for routine prophylaxis up to 5.5 years had no joint damage as measured by MRI, compared with 55% (16 of 29) of children given enhanced episodic treatment with Kogenate or Kogenate FS (P=0.002)1,2       The difference between the 2 groups was statistically significant when using MRI but not when using x-ray alone2       There were no life-threatening bleeds in the routine prophylaxis group (0 of 32 patients) compared with approximately 10% (3 of 33) in the episodic group1         Most adverse events were associated with central venous access, and there were no statistically significant differences between the 2 study groups1,2       Overall, 12.5% (8 of 64) of study patients developed any level of inhibitors over the 5.5-year study2         Two patients developed high-titer inhibitors and were withdrawn from the study1,2       Previously Untreated Patient (PUP) Inhibitor Registry Data:     Postmarketing registries in previously untreated patients taking Kogenate FS have shown inhibitor development rates of 31-50% which is comparable to previously reported inhibitor rates for FVIII products. Some of these registries showed a trend towards an increased risk of inhibitor development in PUPs taking Kogenate FS, as compared to another rFVIII product2     Joint Outcome Study description: A total of 65 boys <30 months of age with severe hemophilia A (FVIII level <2 IU/dL) and with <2 bleeds into each index joint and normal baseline joint imaging, were observed for up to 5.5 years in a multicenter, open-label, prospective, randomized, controlled clinical study. Patients received either 25 IU/kg every other day (primary prophylaxis; n=32) or at least 3 doses totaling a minimum of 80 IU/kg at the time of a bleeding episode (enhanced episodic; n=33). Joint damage was evaluated by magnetic resonance imaging (MRI) or radiography, and the frequency of bleeding episodes was assessed.1,2       INDICATIONS       Kogenate FS antihemophilic factor (recombinant) is a recombinant factor VIII indicated for:     Control and prevention of bleeding episodes in adults and children with hemophilia A.     Surgical prophylaxis in adults and children with hemophilia A.     Routine prophylactic treatment to prevent or 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 prophylactic treatment to prevent or 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 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 hemophilia A patients with their Kogenate FS treatment. If you’d like to speak more, please feel free to contact me at the number below. | 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. | Thank you for reviewing this information on Kogenate FS. 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. | 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. | 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         References: 1. Manco-Johnson MJ, Abshire TC, Shapiro AD, et al. Prophylaxis versus episodic treatment to prevent joint disease in boys with severe hemophilia. N Engl J Med. 2007;357(6):535-544. 2. Kogenate® FS with Vial Adapter [package insert]. Whippany, NJ: Bayer HealthCare LLC; 2015.       Bayer, the Bayer Cross, and Kogenate are registered trademarks of Bayer. © 2015 Bayer HealthCare Pharmaceuticals Inc. All rights reserved.  12/15  PP-575-US-2113   Please note: this e-mail is not monitored for replies. 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