Important Safety Information
What is Afluria® Influenza Vaccine?
Afluria is an inactivated (virus is not alive) influenza vaccine used for immunization against influenza disease caused by influenza virus subtypes A and B present in the vaccine.
Afluria cannot give you the flu. It stimulates the immune system to produce antibodies that can help to protect against influenza; the full effect of the vaccine is generally achieved approximately three weeks after receiving your vaccination. Annual vaccination is recommended against influenza.
Who should receive Afluria?
Afluria administered by needle and syringe can be used in patients five years of age and older.
Afluria can be used with the PharmaJet® Stratis® Needle-Free Injection System in patients 18 through 64 years of age.
Who should not receive Afluria?
Do not receive Afluria if you have an egg allergy. Talk with your doctor if you have ever had a severe allergic reaction after receiving a flu vaccine. Talk with your doctor if you have ever had Guillain-Barré Syndrome (GBS).
Talk with your doctor if you get infections easily, are pregnant, or nursing.
What are the side effects of Afluria?
Fever side effects were observed in children 5 through 8 years of age in 2010.
The most common injection-related adverse reactions in children (5 through 17 years of age) administered Afluria with needle and syringe were pain, redness, and swelling. The most common side effects were headache, muscle pain, irritability, feeling tired and sick, and fever.
The most common injection-related adverse reactions in adults (18 through 64) administered Afluria with needle and syringe were tenderness, pain, swelling, redness, and itching. The most common side effects in adults were muscle aches, headache, and feeling tired and sick.
The most common injection-related adverse reactions in adults (18 through 64) administered Afluria by the PharmaJet Stratis Needle-Free Injection System up to 7 days after vaccination were tenderness, swelling, pain, redness, itching, and bruising. The most common side effects were muscle pain, feeling tired and sick, and headache.
In adults age 65 and older, when administered Afluria by needle and syringe, the most common injection-related adverse reactions were tenderness and pain.
What do I do if I have side effects?
Report any severe or unusual side effects to your healthcare provider.
Please see the full prescribing information for Afluria for further information. To report SUSPECTED ADVERSE REACTIONS, contact Seqirus USA Inc. at 1 855 358 8966 or VAERS at 1-800-822-7967 or www.vaers.hhs.gov.
You are also encouraged to report negative side effects of prescription drugs to the FDA.
Visit http://www.fda.gov/medwatch, or call 1-800-FDA-1088.
The information provided here is not comprehensive. To learn more, talk about Afluria with your healthcare provider or pharmacist. The FDA-approved product labeling can be found at http://www.afluria.com/prescribing-information.aspx or 1 855 358 8966.