Choose seasonal influenza prevention across generations
APPROVED FOR PATIENTS6+ MONTHS1
A seasonal influenza vaccine for a wide range of ages
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- Administer as a 0.25-mL dose for patients 6 through 35 months, and as a 0.5-mL dose for patients 36 months through 8 years as 1 or 2* doses1
- Demonstrated immunogenicity in children and adults1
- Demonstrated safety profile1
- Produced through traditional egg-based manufacturing1
*1 or 2 doses depends on vaccination history as per Advisory Committee on Immunization Practices annual recommendations on prevention and control of influenza with vaccines.
Demonstrated safety profile1
APPROVED FOR PERSONS 6 MONTHS OF AGE AND OLDER.1
Proportion of subjects per age with any solicited local adverse reactions or systemic adverse effects within 7 days after administration of AFLURIA QUADRIVALENT.1
The safety and efficacy of AFLURIA QUADRIVALENT in persons less than 6 months of age have not been established.1
The PharmaJet® Stratis® Needle-Free Injection System is not approved as a method of administering AFLURIA to persons less than 18 and greater than 64 years of age due to lack of adequate data supporting safety and efficacy in these populations.
Data for AFLURIA QUADRIVALENT are relevant to AFLURIA because both vaccines are manufactured using the same process and have overlapping compositions.
For intramuscular injection only, by needle and syringe (6 months and older) or by PharmaJet® Stratis® Needle-Free Injection System (18 through 64 years).1
AFLURIA is supplied in 2 product presentations: as a package of ten 0.5-mL single-dose, prefilled, needleless syringes, or as a 5-mL multidose vial.1
Administer as a 0.25-mL dose for patients 6 through 35 months, and as a 0.5-mL dose for patients 36 months through 8 years as 1 or 2* doses.1
Both the multidose vial and prefilled syringe presentations are not made with natural rubber latex.1
*1 or 2 doses depends on vaccination history as per Advisory Committee on Immunization Practices annual recommendations on prevention and control of influenza with vaccines.
Store AFLURIA refrigerated at 2°C to 8°C (36°F to 46°F). Protect from light. Do not freeze. Discard if the vaccine has been frozen. Do not use it after expiration date.1
Choose AFLURIA for your eligible patients 6+ months1
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Influenza impacts millions of people in the US3
Learn about the burden of influenza
INDICATION AND IMPORTANT SAFETY INFORMATION
IMPORTANT SAFETY INFORMATION
CONTRAINDICATIONS
Do not administer FLUAD or AFLURIA to anyone with a history of a severe allergic reaction (e.g., anaphylaxis) to any component of the vaccine, including egg protein, or to a previous influenza vaccine.
Do not administer FLUCELVAX to anyone with a history of severe allergic reaction (e.g., anaphylaxis) to any component of the vaccine.
WARNINGS AND PRECAUTIONS
If Guillain-Barré syndrome (GBS) has occurred within 6 weeks of receipt of previous influenza vaccine, the decision to give FLUAD, FLUCELVAX, or AFLURIA should be based on careful consideration of the potential benefits and risks.
Appropriate medical treatment must be immediately available to manage potential anaphylactic reactions following administration of FLUAD, FLUCELVAX, or AFLURIA.
Syncope (fainting) may occur in association with administration of injectable vaccines. Procedures should be in place to avoid injury from fainting.
The immune response to FLUAD, FLUCELVAX, and AFLURIA in immunocompromised persons, including individuals receiving immunosuppressive therapy, may be lower than in immunocompetent individuals.
Vaccination with FLUAD, FLUCELVAX, or AFLURIA may not protect all vaccine recipients against influenza disease.
ADVERSE REACTIONS
FLUAD:
The most common (≥ 10%) local and systemic adverse reactions in adults 65 years of age and older who received FLUAD were injection site pain (25%), injection site tenderness (21%), myalgia (15%), fatigue (13%) and headache (13%). Other adverse events may occur.
FLUCELVAX:
Data for FLUCELVAX QUADRIVALENT are relevant to FLUCELVAX because both vaccines are manufactured using the same process and have overlapping compositions.
In children 6 months through 3 years of age who received FLUCELVAX QUADRIVALENT, the most commonly reported injection-site adverse reactions were tenderness (28%), erythema (26%), induration (17%) and ecchymosis (11%). The most common systemic adverse reactions were irritability (28%), sleepiness (27%), diarrhea (18%) and change of eating habits (17%).
In children 4 through 8 years of age who received FLUCELVAX, the most commonly reported local injection-site adverse reactions were pain (29%) and erythema (11%). The most common systemic adverse reaction was fatigue (10%).
In children and adolescents 9 through 17 years of age who received FLUCELVAX, the most commonly reported injection-site adverse reactions were pain (34%) and erythema (14%). The most common systemic adverse reactions were myalgia (15%) and headache (14%).
In adults 18 through 64 years of age who received FLUCELVAX, the most commonly reported injection-site adverse reactions were pain (28%) and erythema (13%). The most common systemic adverse reactions were headache (16%), fatigue (12%), myalgia (11%) and malaise (10%).
In adults ≥ 65 years who received FLUCELVAX the most commonly reported injection-site reaction was erythema (10%). The most common systemic adverse reactions were fatigue (11%), headache (10%) and malaise (10%).
Other adverse events may occur.
AFLURIA:
Data for AFLURIA QUADRIVALENT are relevant to AFLURIA because both vaccines are manufactured using the same process and have overlapping compositions.
Administered by needle and syringe (AFLURIA QUADRIVALENT data):
In children 6 months through 35 months of age, the most commonly reported injection-site reactions were pain and redness (≥ 20%). The most common systemic adverse reactions were irritability (≥ 30%), diarrhea and loss of appetite (≥ 20%).
In children 36 through 59 months of age, the most commonly reported injection site reactions were pain (≥ 30%) and redness (≥ 20%). The most commonly reported systemic adverse reactions were malaise and fatigue, and diarrhea (≥ 10%).
In children 5 through 8 years, the most commonly reported injection-site adverse reactions were pain (≥ 50%), redness and swelling (≥ 10%). The most common systemic adverse reaction was headache (≥ 10%).
In children 9 through 17 years, the most commonly reported injection-site adverse reactions were pain (≥ 50%), redness and swelling (≥ 10%). The most common systemic adverse reactions were headache, myalgia, and malaise and fatigue (≥ 10%).
In adults 18 through 64 years, the most commonly reported injection-site adverse reaction was pain (≥ 40%). The most common systemic adverse reactions were myalgia and headache (≥ 20%).
In adults 65 years of age and older, the most commonly reported injection-site adverse reaction was pain (≥ 20%). The most common systemic adverse reaction was myalgia (≥ 10%).
Administered by the PharmaJet Stratis Needle-Free Injection System:
In adults 18 through 64 years of age, the most commonly reported injection-site adverse reactions were tenderness (≥ 80%), swelling, pain, redness (≥ 60%), itching (≥ 20%) and bruising (≥ 10%). The most common systemic adverse reactions were myalgia, malaise (≥ 30%), and headache (≥ 20%).
Other adverse events may occur.
To report SUSPECTED ADVERSE REACTIONS, contact CSL Seqirus at 1-855-358-8966 or VAERS at 1-800-822-7967 or www.vaers.hhs.gov.
Before administration, please see the full US Prescribing Information for FLUAD, FLUCELVAX and AFLURIA.
PharmaJet® and STRATIS® are registered trademarks of PharmaJet.
References:
1. AFLURIA. Package insert. Seqirus Inc. 2. Medicare.gov. Flu shots. Accessed May 16, 2024. https://www.medicare.gov/coverage/flu-shots 3. Centers for Disease Control and Prevention. Key facts about seasonal flu vaccine. Accessed March 29, 2024. https://www.cdc.gov/flu/prevent/keyfacts.htm