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Important Safety Information

CONTRAINDICATIONS: ELOCTATE is contraindicated in patients who have had life-threatening hypersensitivity reactions to ELOCTATE or its excipients.

WARNINGS AND PRECAUTIONS: Hypersensitivity reactions have been reported with ELOCTATE. Allergic-type hypersensitivity reactions, including anaphylaxis, have been reported with Factor VIII replacement products. Immediately discontinue ELOCTATE and initiate appropriate treatment if hypersensitivity reactions occur. Formation of neutralizing antibodies (inhibitors) to Factor VIII has been reported following administration of ELOCTATE, including in previously untreated patients. Patients using ELOCTATE should be monitored for the development of Factor VIII inhibitors. Clotting assays (e.g., one-stage) may be used to confirm that adequate Factor VIII levels have been achieved and maintained.

ADVERSE REACTIONS: The most frequently occurring adverse reactions (>0.5% of subjects) in clinical trials were arthralgia, malaise, myalgia, headache, and rash.

INDICATIONS

ELOCTATE® [Antihemophilic factor (recombinant), Fc fusion protein] is a recombinant DNA derived, antihemophilic factor indicated in adults and children with Hemophilia A (congenital Factor VIII deficiency) for: on-demand treatment and control of bleeding episodes, perioperative management of bleeding, and routine prophylaxis to reduce the frequency of bleeding episodes.

Limitation of Use
ELOCTATE is not indicated for the treatment of von Willebrand disease.

References: 1. ELOCTATE® [package insert]. Waltham, MA: Sanofi Genzyme, 2017. 2. Nolan B, et al. Haemophilia. 2016;22:72-80. 3. Data on file, Bioverativ Therapeutics Inc., an affiliate of Sanofi. 4. Blanchette VS, et al. J Thromb Haemost. 2014;12(11):1935-1939. 5. Mahlangu JN, et al. Thromb Haemost. 2016;116:1-8. 6. Nolan B, et al. Haemophilia. 2016;22(1)(suppl):1-10. 7. Mahlangu J, et al. Blood. 2014;123(3):317-325. 8. Clinicaltrials.gov. NCT01454739. https://clinicaltrials.gov/ct2/show/NCT01454739. Accessed April 25, 2018. 9. Young G, et al. J Thromb Haemost. 2015;13:1-11. 10. Clinicaltrials.gov. NCT02234323. https://clinicaltrials.gov/ct2/show/NCT02234323. Accessed April 25, 2018. 11. Shapiro A. Expert Opin Biol Ther. 2013;13(9):1287-1297. 12. Kaneko Y, et al. Science. 2006;313:670-673. 13. ADVATE® [package insert]. Westlake Village, CA: Baxalta US Inc.; 2016. 14. ADYNOVATE® [package insert]. Westlake Village, CA: Baxalta US Inc.; 2016. 15. AFSTYLA® [package insert]. Kankakee, IL: CSL Behring LLC; 2017. 16. ALPHANATE® [package insert]. Los Angeles, CA: Grifols Biologicals Inc.; 2015. 17. HEMOFIL M® [package insert]. Westlake Village, CA: Baxalta US Inc.; 2016. 18. HUMATE-P® [package insert]. Kankakee, IL: CSL Behring LLC; 2014. 19. KOATE®-DVI [package insert]. Research Triangle Park, NC: Grifols Therapeutics Inc.; 2012. 20. KOGENATE FS® [package insert]. Whippany, NJ: Bayer HealthCare LLC; 2016. 21. KOVALTRY® [package insert]. Whippany, NJ: Bayer HealthCare LLC; 2016. 22. MONOCLATE-P® [package insert]. Kankakee, IL: CSL Behring LLC; 2014. 23. NOVOEIGHT® [package insert]. Plainsboro, NJ: Novo Nordisk Inc.; 2016. 24. NUWIQ® [package insert]. Hoboken, NJ: Octapharma USA, Inc.; 2015. 25. RECOMBINATE® [package insert]. Westlake Village, CA: Baxalta US Inc.; 2017. 26. REFACTO® [package insert]. Philadelphia, PA: Wyeth Pharmaceuticals Inc.; 2007. 27. XYNTHA® [package insert]. Philadelphia, PA: Wyeth Pharmaceuticals Inc.; 2014. 28. Lara M, Duncan N, Andres R. Effect of hemophilia treatment center digital monitoring on bleeding rates: 12 month study. Am J Hematol. 2016;91(9):E408.