Important safety information for flublok quadrivalent and fluzone high-dose vaccines

Flublok Quadrivalent and Fluzone High-Dose vaccines should not be administered to anyone who has had a severe allergic reaction (eg, anaphylaxis) to any component (including egg protein for Fluzone High-Dose vaccine) or previous dose of the respective vaccine. In addition, Fluzone High-Dose vaccine should not be administered to anyone who has had a severe allergic reaction to a previous dose of any influenza vaccine.

If Guillain-Barré syndrome has occurred within 6 weeks following previous influenza vaccination, the decision to give Flublok Quadrivalent or Fluzone High-Dose vaccine should be based on careful consideration of the potential benefits and risks.

The most common local and systemic adverse reactions to Flublok Quadrivalent and Fluzone High-Dose vaccines include pain at the injection site; headache and myalgia. Other adverse reactions may occur. Vaccination with Flublok Quadrivalent or Fluzone High-Dose vaccine may not protect all individuals.

Indication for flublok quadrivalent and
fluzone high-dose vaccines

Flublok Quadrivalent and Fluzone High-Dose vaccines are indicated for active immunization for the prevention of influenza disease caused by influenza A subtype viruses and type B virus(es) contained in each vaccine. Flublok Quadrivalent vaccine is approved for use in persons 18 years of age and older. Fluzone High-Dose vaccine is approved for use in persons 65 years of age and older.

Before administration, please see the full Prescribing Information for
Flublok Quadrivalent or Fluzone High-Dose vaccine.

Fluzone High-Dose and Fluzone vaccines are manufactured and distributed by Sanofi Pasteur Inc. Flublok Quadrivalent vaccine is manufactured by Protein Sciences Corporation, a Sanofi company, and distributed by Sanofi Pasteur Inc.

References: 1. . Centers for Disease Control and Prevention (CDC). Influenza (flu): people at high risk of developing flu-related complications. http://www.cdc.gov/flu/about/disease/high_risk.htm. Accessed April 11, 2018. 2. Wang C-S, Wang S-T, Lai C-T, Lin L-J, Chou P. Impact of influenza vaccination on major cause-specific mortality. Vaccine. 2007;25:1196-1203. 3. Warren-Gash C, Blackburn R, Whitaker H, McMenamin J, Hayward AC. Laboratory-confirmed respiratory infections as triggers for acute myocardial infarction and stroke: a self-controlled case series analysis of national linked datasets from Scotland. Eur Respir J. 2018;51(3):1701794. doi.10.1183/13993003.01794-2017. 4. Fluzone High-Dose vaccine [Prescribing Information]. Swiftwater, PA: Sanofi Pasteur Inc. 5. Flublok Quadrivalent vaccine [Prescribing Information]. Meriden, CT: Protein Sciences Corporation. 6. DiazGranados CA, Dunning AJ, Kimmel M, et al. Efficacy of high-dose versus standard-dose influenza vaccine in older adults. N Engl J Med. 2014;371:635-645. 7. Dunkle LM, Izikson R, Patriarca P, et al. Efficacy of recombinant influenza vaccine in adults 50 years of age or older. N Engl J Med. 2017;376:2427-2436.

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