An innovative, comprehensive flu vaccine portfolio

FLUAD® (Influenza Vaccine, Adjuvanted),
FLUCELVAX® (Influenza Vaccine), and
AFLURIA® (Influenza Vaccine)

FLUAD® (Influenza Vaccine, Adjuvanted), FLUCELVAX® (Influenza Vaccine), and AFLURIA® (Influenza Vaccine)

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.