View the SPINART study data

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 Dr. {{accTitle}} {{accFname}} {{accLname}},       We are excited to share data from SPINART (Secondary Prophylaxis in Adults: A Randomized Trial), the study that was used to support our indication for routine prophylaxis to reduce the frequency of bleeding episodes in adults with hemophilia A. SPINART compared on-demand treatment and prophylaxis treatment to determine bleeding frequency after all participants had completed at least 1 year of treatment. Results showed that adults using Kogenate FS as prophylaxis experienced 15.2 times fewer bleeds compared to those treating on demand (95% CI: 8.5, 27.2; P<0.0001).1,2*   *P<0.0001 using negative binomial model.2               In the 42 examined patients treated with prophylaxis, the mean ABR was 2 bleeds per year. In the 42 examined patients treated on demand, the mean ABR was 37 bleeds per year. The P value was less than 0.0001, calculated using ANOVA.1,2   Efficacy assessments were performed after a median follow-up period of 1.4 years.1       SPINART Study Design: A prospective, open-label, randomized, parallel-group study of 84 males aged 15 to 50 years. All patients had severe hemophilia A (FVIII level <1 IU/dL). Forty-two patients received Kogenate FS as prophylaxis, 25 IU/kg 3 times per week, with escalation by 5 IU/kg (to 30 or 35 IU/kg at years 1 and 2, respectively) allowed. Forty-two patients received Kogenate FS on demand following a bleed. The primary endpoint was bleeding frequency after all participants had completed at least 1 year of treatment.1,2       Consider Kogenate FS for your patients with hemophilia A.       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 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.     References: 1. Kogenate® FS with Vial Adapter [prescribing information]. Whippany, NJ: Bayer HealthCare LLC; 2016. 2. Manco-Johnson MJ, Kempton CL, Reding MT, et al. Randomized, controlled, parallel-group trial of routine prophylaxis vs. on-demand treatment with sucrose-formulated recombinant factor VIII in adults with severe hemophilia A (SPINART) [published erratum appears in J Thromb Haemost. 2014;12(1):119-122]. J Thromb Haemost. 2013;11(6):1119-1127.       Bayer, the Bayer Cross, and Kogenate are registered trademarks of Bayer. © 2017 Bayer.  All rights reserved.  03/‌17  PP-575-US-2854       Please note: This email is not monitored for replies. If you would like to contact us, please visit our Contact Us section online.