AFLURIA QUADRIVALENT® Influenza Vaccine

The first FDA-approved quadrivalent influenza vaccine with needle-free option1

About AFLURIA QUADRIVALENT

AFLURIA QUADRIVALENT is an inactivated influenza vaccine indicated for active immunization against influenza disease caused by influenza A subtype viruses and type B viruses contained in the vaccine. AFLURIA QUADRIVALENT is indicated for use in persons 18 years of age and older.

How Supplied

Presentation Carton NDC Number Components
Pre-filled syringe 33332-316-01 Ten 0.5 mL single-dose syringes fitted with a Luer-Lok attachment without needles [NDC 33332-316-02]
Multi-dose vial 33332-416-10 One 5 mL vial, which contains ten 0.5 mL doses [NDC 33332-416-11]

Storage and Handling

  • Store refrigerated at 2-8°C (36-46°F).
  • Do not freeze.  Discard if product has been frozen.
  • Protect from light.
  • Do not use AFLURIA QUADRIVALENT beyond the expiration date printed on the label.
  • Between uses, return the multi-dose vial to the recommended storage conditions.
  • Once the stopper of the multi-dose vial has been pierced the vial must be discarded within 28 days.

Important Safety Information

Contraindications

  • AFLURIA QUADRIVALENT is contraindicated in individuals with known severe allergic reactions (e.g., anaphylaxis) to any component of the vaccine including egg protein, or to a previous dose of any influenza vaccine.

Warnings and Precautions

  • If Guillain-Barré Syndrome (GBS) has occurred within 6 weeks of previous influenza vaccination, the decision to give AFLURIA QUADRIVALENT should be based on careful consideration of the potential benefits and risks.
    The 1976 swine influenza vaccine was associated with an increased frequency of GBS. Evidence for a causal relation of GBS with subsequent vaccines prepared from other influenza viruses is unclear. If influenza vaccine does pose a risk, it is probably slightly more than one additional case per 1 million persons vaccinated.
  • Preventing and Managing Allergic Reactions: Appropriate medical treatment and supervision must be available to manage possible anaphylactic reactions following administration of the vaccine.
  • Altered Immunocompetence: If AFLURIA QUADRIVALENT is administered to immunocompromised persons, including those receiving immunosuppressive therapy, the immune response may be diminished.
  • Limitations of Vaccine Effectiveness: Vaccination with AFLURIA QUADRIVALENT may not protect all individuals.

Adverse Reactions

  • In adults 18 through 64 years, the most commonly reported injection-site adverse reaction when AFLURIA QUADRIVALENT was administered by needle and syringe was pain (≥40%). The most common systemic adverse events were myalgia and headache (≥20%).
  • In adults 65 years of age and older, the most commonly reported injection-site adverse reaction when AFLURIA QUADRIVALENT was administered by needle and syringe was pain (≥20%). The most common systemic adverse event was myalgia (≥10%).
  • In adults 18 through 64 years of age, the most commonly reported injection-site adverse reactions when AFLURIA (trivalent formulation) was administered by the PharmaJet Stratis Needle-Free Injection System were tenderness (≥80%), swelling, pain, redness (≥60%), itching (≥20%), and bruising (≥10%). The most common systemic adverse events were myalgia, malaise (≥30%), and headache (≥20%).

Vaccination with Afluria may not protect all individuals.

Please see full prescribing information for AFLURIA QUADRIVALENT.

You are encouraged to report negative side effects of prescription drugs to the FDA.

Visit www.fda.gov/medwatch or call 1-800-FDA-1088.


References:

  1. AFLURIA QUADRIVALENT [package insert]. King of Prussia, PA: Seqirus USA Inc.; August 2016.