AFLURIA® Influenza Vaccine

A trivalent influenza vaccine with needle-free option1

About AFLURIA

AFLURIA (Influenza Vaccine) 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 is approved for use in persons 5 years of age and older. Anyone 18 through 64 years of age who can get AFLURIA may ask for the needle-free delivery option.

How Supplied

Presentation Carton NDC Number Components
Pre-filled syringe 33332-017-01 Ten 0.5 mL single-dose syringes fitted with a Luer-Lok attachment without needles [NDC 33332-017-02]
Multi-dose vial 33332-117-10 One 5 mL vial, which contains ten 0.5 mL doses [NDC 33332-117-11]

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 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

Indications and Usage

AFLURIA Influenza Vaccine iis an inactivated influenza vaccine indicated for active immunization against influenza disease caused by influenza virus subtypes A and type B present in the vaccine. Administration of Afluria with a needle and syringe is approved for use in persons 5 years of age and older. Administration of Afluria with the PharmaJet® Stratis® Needle-Free Injection System is approved for use in persons 18 through 64 years of age only.

Contraindications

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

Warnings & Precautions

  • Administration of CSL’s 2010 Southern Hemisphere influenza vaccine was associated with increased rates of fever and febrile seizures in children predominantly below the age of 5 years as compared to previous years. Febrile events were also observed in children 5 through 8 years of age. (5.1)
  • If Guillain-Barré Syndrome (GBS) has occurred within 6 weeks of previous influenza vaccination, the decision to give AFLURIA should be based on careful consideration of the potential benefits and risks. (5.2)
  • Appropriate medical treatment and supervision must be available to manage possible anaphylactic reactions following administration of the vaccine. (5.3)
  • Immunocompromised persons may have a diminished immune response to AFLURIA. (5.4)

Adverse Reactions

  • In children 5 through 17 years of age, the most common injection-site adverse reactions when administered by needle and syringe were pain (≥60%), redness (≥20%) and swelling (≥10%). The most common systemic adverse events were headache, myalgia (≥20%), irritability, malaise and fever (≥10%). (6.1)
  • In adults 18 through 64 years of age, the most common injection-site adverse reactions when administered by needle and syringe were tenderness (≥60%), pain (≥40%), swelling (≥20%), and redness, itching (≥10%). The most common systemic adverse events were muscle aches (≥30%) and headache, malaise (≥20%). (6.1)
  • In adults 18 through 64 years of age, the most common injection-site adverse reactions when administered by the PharmaJet Stratis Needle-Free Injection System up to 7 days post-vaccination were tenderness (≥80%), swelling, pain, redness (≥60%), itching (≥20%) and bruising (≥10%). The most common systemic adverse events within this period were myalgia, malaise (≥30%), and headache (≥20%). (6.1)
  • In adults 65 years of age and older, when administered by needle and syringe the most common injection-site adverse reactions were tenderness (≥30%) and pain (≥10%). No systemic adverse events occurred in ≥10% of subjects in this age group. (6.1)

Vaccination with AFLURIA may not protect all individuals.

Please see full prescribing information for AFLURIA.

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 [package insert]. King of Prussia, PA: Seqirus USA Inc.; April 2016.