• Indications and Usage

    FLUARIX QUADRIVALENT is a vaccine indicated for active immunization for the prevention of disease caused by influenza A subtype viruses and type B viruses contained in the vaccine. FLUARIX QUADRIVALENT is approved for use in persons 3 years of age and older.

  • Dosage and Administration

    For intramuscular injection only.

    • 3 to 8 years old (not previously vaccinated with influenza vaccine) – Two doses (0.5 ml each) at least 4 weeks apart
    • 3 to 8 years old (vaccinated with influenza vaccine in a previous season)  – One or two doses (0.5 ml each)
    • 9 years old up – One dose (0.5 ml)
  • Dosage Forms and Strengths

    Suspension for injection supplied in 0.5-mL single-dose prefilled syringes.

  • Contraindications

    History of severe allergic reactions (e.g., anaphylaxis) to any component of the vaccine, including egg protein, or following a previous dose of any influenza vaccine.

  • Warnings and Precaution

    • If Guillain-Barré syndrome has occurred within 6 weeks of receipt of a prior influenza vaccine, the decision to give FLUARIX QUADRIVALENT should be based on careful consideration of potential benefits and risks.
    • The tip caps of the prefilled syringes of FLUARIX QUADRIVALENT may contain natural rubber latex which may cause allergic reactions in latex-sensitive individuals.
    • Syncope (fainting) can occur in association with administration of injectable vaccines, including FLUARIX QUADRIVALENT. Procedures should be in place to avoid falling injury and to restore cerebral perfusion following syncope.
  • Adverse Reactions

    • In adults, the most common (>10%) injection site adverse reaction was pain (36%); the most common systemic adverse events were muscle aches (16%), headache (16%), and fatigue (16%).
    • In children 3 through 17 years of age, the injection site adverse reactions were pain (44%), redness (23%), and swelling (19%).
    • In children 3 through 5 years of age, the most common (>10%) systemic adverse events were drowsiness (17%), irritability (17%), and loss of appetite (16%); in children 6 through 17 years of age, the most common systemic adverse events were fatigue (20%), muscle aches (18%), headache (16%), arthralgia (10%), and gastrointestinal symptoms (10%).
  • Use in Specific Populations

    • Safety and effectiveness of FLUARIX QUADRIVALENT have not been established in pregnant women or nursing mothers.
    • Geriatric Use: Antibody responses were lower in geriatric subjects who received FLUARIX QUADRIVALENT than in younger subjects.