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 people 5 years of age and older.

How Supplied

Presentation Carton NDC Number Components
Pre-filled syringe 33332-317-01 Ten 0.5 mL single-dose syringes fitted with a Luer-Lok attachment without needles [NDC 33332-317-02]
Multi-dose vial 33332-417-10 One 5 mL vial, which contains ten 0.5 mL doses [NDC 33332-417-11]

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

INDICATION

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 approved for use in individuals 5 years of age and older.

Contraindications

  • 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.
  • Appropriate medical treatment and supervision must be available to manage possible anaphylactic reactions following administration of the vaccine.
  • Immunocompromised persons may have a diminished immune response to AFLURIA QUADRIVALENT

Adverse Reactions

  • In adults 18 through 64 years, the most commonly reported injection-site adverse reaction when 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 administered by needle and syringe was pain (≥20%). The most common systemic adverse event was myalgia (≥10%).
  • In children 5 through 8 years, the most commonly reported injection-site adverse reactions when administered by needle and syringe were pain (≥50%), redness and swelling (≥10%). The most common systemic adverse event was headache (≥10%).
  • In children 9 through 17 years, the most commonly reported injection-site adverse reactions when administered by needle and syringe were pain (≥50%), redness and swelling (≥10%). The most common systemic adverse events were headache, myalgia, and malaise and fatigue (≥10%).

The safety experience with AFLURIA (trivalent formulation) is relevant to AFLURIA QUADRIVALENT because both vaccines are manufactured using the same process and have overlapping compositions:

  • In adults 18 through 64 years of age, the most commonly reported injection-site adverse reactions with AFLURIA (trivalent formulation) when 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%).

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). Seqirus USA Inc.; July 2017