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 33332-318-01 Ten 0.5 mL single-dose syringes fitted with a Luer-Lok attachment without needles [NDC 33332-318-02]
Multi-dose vial 33332-418-10 One 5 mL vial, which contains ten 0.5 mL doses [NDC 33332-418-11]

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.

AFLURIA® QUADRIVALENT (Influenza Vaccine) 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%).

To report Suspected Adverse Reactions, contact Seqirus Vaccines at 1-855-358-8966 or VAERS at 1-800-822-7967 and www.vaers.hhs.gov.

Please see full prescribing information for AFLURIA QUADRIVALENT.

AFLURIA is a registered trademark of Seqirus UK Limited or its affiliates.

PharmaJet® and STRATIS® are registered trademarks of PharmaJet.


References:

  1. Afluria Quadrivalent (package insert). Seqirus USA Inc.; July 2017