Important Safety Information for Afluria
Afluria® Influenza Vaccine 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. 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.
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.
Administration of CSL's 2010 Southern Hemisphere influenza vaccine was associated with postmarketing reports of increased rates of fever and febrile seizures in children predominantly below the age of 5 years as compared to previous years; these increased rates were confirmed by postmarketing studies. Febrile events were also observed in children 5 to less than 9 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.
If Afluria is administered to immunocompromised persons, including those receiving immunosuppressive therapy, the immune response may be diminished.
Afluria should be given to a pregnant woman only if clearly needed.
Afluria has not been evaluated in nursing mothers. It is not known whether Afluria is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Afluria is administered to a nursing woman.
Antibody responses in persons 65 years of age and older were lower after administration of Afluria as compared to younger adult subjects.
In children 5 through 17 years of age, most common injection-site adverse reactions observed in clinical studies of Afluria when administered by needle and syringe were pain, redness, and swelling. The most common systemic adverse events were headache, myalgia, irritability, malaise, and fever.
In adults 18 through 64 years of age, the most common injection-site adverse reactions observed in clinical studies of Afluria when administered by needle and syringe were tenderness, pain, swelling, redness, and itching. The most common systemic adverse reactions observed were muscle aches, headache, and malaise.
In adults 18 through 64 years of age, the most common injection-site adverse reactions observed in clinical studies of Afluria when administered by the PharmaJet Stratis Needle-Free Injection System up to 7 days post-vaccination were tenderness, swelling, pain, redness, itching, and bruising. The most common systemic adverse events within this period were myalgia, malaise, and headache.
In adults 65 years of age and older, the most common injection-site adverse reactions observed in clinical studies of Afluria when administered by needle and syringe were tenderness and pain.
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.