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Important Safety Information Medical Information

Please see full Prescribing Information for Fluzone® High-Dose (Influenza Vaccine), Flublok® (Influenza Vaccine), and Fluzone® (Influenza Vaccine).

FLUZONE HIGH-DOSE AND FLUBLOK CAN HELP PREVENT FLU-RELATED HOSPITALIZATIONS

Fluzone High-Dose and Flublok are the only higher-dose flu shots proven to prevent more flu in older adults than a standard-dose influenza vaccine in RCTs.3,6,8

In a randomized controlled trial, Fluzone High-Dose (Influenza Vaccine) trivalent formulation provided 24% (95% CI: 10-37) better protection against influenza due to any lab-confirmed circulating strains vs a standard-dose influenza vaccine in adults 65 years of age and older.2,8

Solicited injection-site reactions and systemic adverse reactions were more frequent after vaccination with Fluzone High-Dose compared to Fluzone.2

Click here for full efficacy and safety data.

In a randomized controlled trial, Flublok (quadrivalent) provided 30% (95% CI: 10-47) better protection against influenza due to any PCR-confirmed circulating strains vs a standard-dose quadrivalent inactivated influenza vaccine in adults 50 years of age and older.1,3

THE MOST COMMON ADVERSE REACTIONS FOR FLUBLOK ARE STATED BELOW PER THE PRESCRIBING INFORMATION

In adults 18 through 49 years of age, the most common (≥10%) injection-site adverse reaction was pain (37%); the most common (≥10%) solicited systemic adverse reactions were headache (15%), fatigue (15%) and muscle pain (11%).1

In adults 50 through 64 years of age, the most common (≥10%) injection site adverse reaction was pain (32%); the most common (≥10%) solicited systemic adverse reactions were headache (17%), fatigue (13%), and muscle pain (11%).1

In adults 65 years of age and older, the most common (≥10%) injection site adverse reaction was pain (19%); the most common (≥10%) solicited systemic adverse reactions were fatigue (13%) and headache (10%).1

The efficacy of the quadrivalent formulation is relevant to Flublok since both vaccines are manufactured according to the same process and have overlapping compositions.1

Click here for full efficacy and safety data.

PCR=polymerase chain reaction.
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vaccine icon These vaccines and their administration are covered by Medicare and most commercial insurers.a

aThe information above is available at CMS.gov. The information is provided for informational purposes only and is not a guarantee of coverage. The information is gathered from various resources and is subject to change.

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INDICATIONS

Fluzone, Flublok, and Fluzone High-Dose are vaccines indicated for active immunization for the prevention of disease caused by influenza A subtype viruses and type B virus contained in the vaccine. Fluzone is approved for use in persons 6 months of age and older. Flublok is approved for use in persons 18 years of age and older. Fluzone High-Dose is approved for use in persons 65 years of age and older.

IMPORTANT SAFETY INFORMATION

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Do not administer Fluzone, Flublok, or Fluzone High-Dose to anyone with a history of a severe allergic reaction (e.g., anaphylaxis) to any component of the vaccine (including egg protein for Fluzone and Fluzone High-Dose). Fluzone and Fluzone High-Dose should not be administered to anyone who has had a severe allergic reaction after previous dose of any influenza vaccine.

Appropriate medical treatment must be immediately available to manage potential anaphylactic reactions following administration of the vaccine.

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

If Fluzone, Flublok, or Fluzone High-Dose are administered to immunocompromised persons, including those receiving immunosuppressive therapy, the expected immune response may not be attained.

Vaccination with Fluzone, Flublok, or Fluzone High-Dose may not protect all recipients.

Syncope (fainting) has been reported following vaccination with Fluzone, Flublok and Fluzone High-Dose. Procedures should be in place to avoid injury from fainting.

For Fluzone, in children 6 months through 8 years of age, the most common injection-site adverse reactions were pain or tenderness and redness; the most common solicited systemic adverse reactions were irritability, drowsiness (6 months through 35 months), and myalgia (3 years through 8 years). In adults 18 through 64 years of age, the most common injection-site adverse reaction was pain; the most common solicited systemic adverse reactions were headache and myalgia. In adults over 65 years of age, the most common injection-site adverse reaction was pain; the most common solicited systemic adverse reactions were headache, myalgia, and malaise.

For Flublok, in adults 18 through 64 years of age, the most common injection site adverse reaction was pain; the most common solicited systemic adverse reactions were headache, fatigue, and myalgia. In adults 65 years of age and older, the most common injection-site adverse reaction was pain; the most common solicited systemic adverse reactions were fatigue and headache.

For Fluzone High-Dose, in adults 65 years of age and older, the most common injection-site reaction was pain; the most common solicited systemic adverse reactions were myalgia, malaise, and headache.

For Fluzone, Flublok, and Fluzone High-Dose, other adverse reactions may occur.

Before administration, please see the full Prescribing Information for Fluzone, Flublok, or Fluzone High-Dose. Also, please see complete Patient Information for Fluzone or Fluzone High-Dose.

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MAT-US-2019703-v4.0-07/2024
MAT-US-2019703-v4.0-07/2024