HELP YOUR PATIENTS STAND STRONG AGAINST THE FLU WITH THE PROTECTION OF AFLURIA

ABOUT AFLURIA1,2

  • Afluria Quadrivalent and Afluria are inactivated influenza vaccines indicated for active immunization against influenza disease caused by influenza virus subtypes A and type B viruses present in the vaccine. Afluria Quadrivalent helps protect against 4 common types of flu viruses, while Afluria helps protect against 3 types.
  • Afluria is contraindicated in individuals with known severe allergic reaction (eg, anaphylaxis) to any component
    of the vaccine including egg protein, or to a previous dose of any influenza vaccine. Learn more about the Efficacy and Safety of Afluria.
  • AFLURIA PRESENTATIONS
  • AFLURIA DOSING AND ADMINISTRATION
  • PHARMAJET STRATIS NEEDLE-FREE
  • HOW AFLURIA IS MADE

AFLURIA OFFERS YOU THE FLEXIBILITY OF 2 PRODUCT PRESENTATIONS1,2

  • Single-use, pre-filled syringe (0.5 mL) Thimerosal-Free
  • 5 mL multi-dose vial
    (contains ten 0.5 mL doses) with peel-off labels Contains thimerosal as a preservative
  • Neither Afluria presentation is made with natural rubber latex1,2

Afluria is contraindicated in individuals with known severe allergic reaction (eg, anaphylaxis) to any component of the vaccine including egg protein, or to a previous dose of any influenza vaccine. The rubber tip cap and plunger used for the preservative-free, single-dose syringes and the rubber stoppers used for the multi-dose vial were not made with natural rubber latex.

DOSING AND ADMINISTRATION1,2

  • Intramuscular injection, using needle and syringe, in patients 5 years of age and older*
  • PharmaJet® Stratis® Needle-Free Injector in patients 18 through 64 years of age
  • A single dose is 0.5 mL
Dosing and Administration

* The Advisory Committee on Immunization Practices recommends that Afluria not be used in children less than 5 years of age because of this age group’s increased risk of febrile reactions with CSL’s 2010 Southern Hemisphere flu vaccine.1-3

1 or 2 doses depends on vaccination history as per the Advisory Committee on Immunization Practices annual recommendations
on prevention and control of influenza with vaccines.

INNOVATIVE ADMINISTRATION OF AFLURIA WITH THE PHARMAJET STRATIS NEEDLE-FREE INJECTOR4

For retail pharmacies and medical providers focused on increasing vaccination rates, the combination of Afluria and PharmaJet provides a safe, effective, and needle-free option for patients age 18 through 64.1,2,4-6

AFLURIA QUADRIVALENT AND AFLURIA ARE THE ONLY FDA-APPROVED FLU VACCINES FOR ADMINISTRATION WITH THE PHARMAJET STRATIS NEEDLE-FREE INJECTOR7

FDA APPROVAL WAS BASED ON RESULTS FROM A STUDY PUBLISHED IN THE LANCET4
VIEW EFFICACY & SAFETY RESULTS

How does the PharmaJet Stratis Needle-Free Injector Work?8

  • Delivers Afluria intramuscularly through a narrow, precise fluid stream that penetrates the skin in about one-tenth of a second
  • Single-use, 0.5 mL, fixed-volume syringe; auto-disabling; inherent dose accuracy
  • No external power source required—injector tested to 20,000 cycles

Benefits of the PharmaJet Stratis Needle-Free Injector

  • Effectively administers Afluria1,2,4,8
  • Safe—eliminates needlestick injuries, sharps management and disposal8
  • Minimal training required8
    • A variety of training options, such as self-guided or online, are available
  • Comfortable—minimizes needle fear and anxiety5,6
  • 93% of those who received their vaccination using PharmaJet indicated that they would likely choose a needle-free injection again for their next vaccination9

Which Patients Can Be Administered Afluria With the PharmaJet Stratis
Needle-Free Injector?1,2

Adults 18 through 64 years of age who have not experienced a severe allergic reaction (such as anaphylaxis) to any component of the vaccine, including egg protein, or to a previous dose of any influenza vaccine.

Visit www.pharmajet.com to Order or Learn More About the PharmaJet Stratis
Needle-Free Injector

AFLURIA IS MANUFACTURED USING THE HIGHEST QUALITY-CONTROL STANDARDS

Afluria is manufactured by Seqirus Pty Ltd. and distributed by Seqirus USA Inc. Seqirus has dedicated production facilities in Holly Springs, North Carolina, Kankakee, Illinois, Melbourne, Australia, and Marburg Germany.

Afluria manufacturing

Each facility is subject to regular inspections by the FDA and other regulatory agencies. To ensure
consistent quality of vaccines, every step of the manufacturing process and supply chain is tightly
controlled, including:

  • Close monitoring of egg production
  • Skillful seed development
  • Temperature- and environment-controlled product distribution

Manufacturing Process

Afluria manufacturing steps 1 - 3

Reliable Distribution of Afluria

Seqirus is a key provider of the influenza vaccine in the world today and strives to meet immunization
needs with a consistent supply of influenza vaccine when and where it is needed.

References: 1. Afluria Quadrivalent [package insert]. Summit, NJ: Seqirus USA Inc; 2017. 2. Afluria [package insert]. Summit, NJ: Seqirus USA Inc; 2017. 3. CDC. Prevention and control of seasonal influenza with vaccines: Recommendations of the advisory committee on immunization practices — United States, 2017–18 influenza season. https://www.cdc.gov/mmwr/volumes/66/rr/rr6602a1.htm. Updated August 24, 2017. Accessed September 10, 2017. 4. McAllister L, Anderson J, Werth K, et al. Needle-free jet injection for administration of influenza vaccine: a randomised non-inferiority trial. Lancet. 2014;384(9944):674-861. 5. Nir Y, Paz A, Sabo E, Potasman I. Fear of injections in young adults: prevalence and associations. Am J Trop Med Hyg. 2003;68(3):341-344. 6. Wright S, Yelland M, Heathcote K, Ng S-K. Fear of needles: nature and prevalence in general practice. Aust Fam Physician. 2009;38(3):172-176. 7. Seqirus receives FDA approval of Afluria® Quadrivalent (Influenza Vaccine) for people five years of age and older in the US. [press release]. Cambridge, MASS: Seqirus USA Inc.; September 5, 2017. 8. Stratis® needle-free injection. PharmaJet® Stratis® Needle-Free Injector Web site. http://pharmajet.com/wp-content/uploads/2016/03/60-10369-001RevA_Stratis-Product-Sheet.pdf. Accessed September 14, 2017. 9. Product survey. PharmaJet® Stratis® Needle-Free Injector Web site. https://pharmajet.com/wp-content/uploads/2015/02/60-10351-005A_Stratis-Survey-Patient-Surveys-Combined.pdf. Accessed September 14, 2017.

AT Seqirus, DELIVERING VACCINES IS OUR MISSION AND PROTECTING LIFE IS OUR PASSION

seqirus

The product information presented on this site is for U.S. residents only. Afluria® Quadrivalent, Afluria®, and Seqirus are trademarks of Seqirus UK Limited or its affiliates. PharmaJet® and Stratis® are registered trademarks of PharmaJet Inc. Manufactured by: Seqirus Pty Ltd Parkville, Victoria, 3052, Australia Distributed by: Seqirus USA Inc. 25 Deforest Avenue, Summit, NJ 07901, USA © 2017 Seqirus USA Inc. www.seqirus-us.com MCC Code, Month 2017

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%).

Please see accompanying 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.


AFLURIA® (Influenza Vaccine) Important Safety Information

INDICATION

AFLURIA is an inactivated influenza vaccine indicated for active immunization against influenza disease caused by influenza virus subtypes A and type B present in the vaccine. AFLURIA is approved for use in persons 5 years of age and older.

CONTRAINDICATIONS
  • Severe allergic reaction (e.g., anaphylaxis) to any component of the vaccine including egg protein, or to a previous dose of any influenza vaccine.
WARNINGS AND PRECAUTIONS
  • Administration of CSL’s 2010 Southern Hemisphere influenza vaccine has been 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.
  • 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.
  • 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.
ADVERSE REACTIONS
  • In children five 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%).
  • 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%) headache and malaise (≥20%).
  • 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%).
  • 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.

Please see accompanying 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.

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