These highlights do not include all the information needed to use Fluzone ® Quadrivalent safely and effectively. See full prescribing information for Fluzone Quadrivalent.
Fluzone Quadrivalent (Influenza Vaccine)
Suspension for Intramuscular Injection
2019-2020 Formula
Initial U.S. Approval (Fluzone Quadrivalent): 2013
RECENT MAJOR CHANGES
Dosage and Administration (2.1) 01/2019
INDICATIONS AND USAGE
Fluzone Quadrivalent is a vaccine indicated for active immunization for the prevention of influenza disease caused by influenza A subtype viruses and type B viruses contained in the vaccine. (1)
Fluzone Quadrivalent is approved for use in persons 6 months of age and older. (1)
DOSAGE AND ADMINISTRATION
For intramuscular use only (2)
Age Vaccination Status Dose Schedule
"-" Indicates information is not applicable
*
The schedule can be completed as two 0.25-mL doses ≥4 weeks apart, two 0.5-mL doses ≥4 weeks apart, or any combination of 2 doses (either 0.25 mL or 0.5 mL) administered ≥4 weeks apart.
†
To determine if 1 or 2 doses are required, refer to Advisory Committee on Immunization Practices annual recommendations on prevention and control of influenza with vaccines.
6 months through 35 months Not previously vaccinated with influenza vaccine or unknown vaccination history Two doses, either 0.25 mL or 0.5 mL* Administer at least 4 weeks apart
Previously vaccinated with influenza vaccine One or two doses†, either 0.25 mL or 0.5 mL* If two doses, administer at least 4 weeks apart
36 months through 8 years Not previously vaccinated with influenza vaccine or unknown vaccination history Two 0.5 mL doses Administer at least 4 weeks apart
Previously vaccinated with influenza vaccine One or two 0.5 mL doses† If two doses, administer at least 4 weeks apart
9 years and older - One 0.5 mL dose -
DOSAGE FORMS AND STRENGTHS
Suspension for injection supplied in 4 presentations: prefilled single-dose syringe (pink plunger rod), 0.25 mL; prefilled single-dose syringe (clear plunger rod), 0.5 mL; single-dose vial, 0.5 mL; multi-dose vial, 5 mL. (3)
CONTRAINDICATIONS
Severe allergic reaction (e.g., anaphylaxis) to any component of the vaccine, including egg protein, or after previous dose of any influenza vaccine. (4)
WARNINGS AND PRECAUTIONS
If Guillain-Barré syndrome (GBS) has occurred within 6 weeks following previous influenza vaccination, the decision to give Fluzone Quadrivalent should be based on careful consideration of the potential benefits and risks. (5.1)
ADVERSE REACTIONS
In children 6 months through 35 months of age, the most common (≥10%) injection-site reactions were pain (57%) or tenderness (47%�"54%), erythema (23%�"37%), and swelling (13%�"22%); the most common solicited systemic adverse reactions were irritability (47%�"54%), abnormal crying (33%�"41%), malaise (38%), drowsiness (31%�"38%), appetite loss (27%�"32%), myalgia (27%), vomiting (10%�"15%), and fever (11%�"14%). (6.1)
In children 3 years through 8 years of age, the most common (≥10%) injection-site reactions were pain (67%), erythema (34%), and swelling (25%); the most common solicited systemic adverse reactions were myalgia (39%), malaise (32%), and headache (23%). (6.1)
In adults 18 years and older, the most common (≥10%) injection-site reaction was pain (47%); the most common solicited systemic adverse reactions were myalgia (24%), headache (16%), and malaise (11%). (6.1)
In adults 65 years of age and older, the most common (≥10%) injection-site reaction was pain (33%); the most common solicited systemic adverse reactions were myalgia (18%), headache (13%), and malaise (11%). (6.1)
To report SUSPECTED ADVERSE REACTIONS, contact Sanofi Pasteur Inc., at 1-800-822-2463 (1-800-VACCINE) or VAERS at 1-800-822-7967 or www.vaers.hhs.gov.
USE IN SPECIFIC POPULATIONS
Pregnancy: Pregnancy exposure registry available. Call Sanofi Pasteur Inc. at 1-800-822-2463.
Antibody responses to Fluzone Quadrivalent are lower in persons ≥65 years of age than in younger adults. (8.5)
See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling.
Revised: 7/2019