HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use AFLURIA safely and effectively. See full prescribing information for AFLURIA. AFLURIA, Influenza Virus Vaccine Suspension for Intramuscular Injection 2009-2010 Formula Initial U.S. Approval: 2007 -RECENT MAJOR CHANGES- Indications and Usage (1) 11/2009 Dosage and Administration (2.2) 11/2009 -INDICATIONS AND USAGE- ?AFLURIA is an inactivated influenza virus vaccine indicated for active immunization of persons ages 6 months and older against influenza disease caused by influenza virus subtypes A and type B present in the vaccine. (1) ?This indication is based on the immune response elicited by AFLURIA; there have been no controlled clinical studies demonstrating a decrease in influenza disease after vaccination with AFLURIA. (14)-DOSAGE AND ADMINISTRATION- Children ?6 months through 35 months of age (0.25 mL dose, intramuscular injection): Previously unvaccinated children should receive two 0.25 mL doses; one on day 1 followed by another approximately 4 weeks later. (2.2) Previously vaccinated children should receive only one 0.25 mL dose. (2.2) ? 36 months through 8 years of age (0.5 mL dose, intramuscular injection): Previously unvaccinated children should receive two 0.5 mL doses, one on day 1 followed by another approximately 4 weeks later. (2.2) Previously vaccinated children should receive only one 0.5 mL dose. (2.2) ? 9 years of age and older A single 0.5 mL dose for intramuscular injection. (2.2) Adults A single 0.5 mL dose for intramuscular injection. (2.2)-DOSAGE FORMS AND STRENGTHS- AFLURIA, a sterile suspension for intramuscular injection, is supplied in three presentations: ? 0.25 mL single-dose, pre-filled syringe, no preservative. (3) ? 0.5 mL single-dose, pre-filled syringe, no preservative. (3) ?5 mL multi-dose vial containing ten doses. Thimerosal, a mercury derivative, is added as a preservative; each 0.5 mL dose contains 24.5 micrograms (mcg) of mercury. (3,11)-CONTRAINDICATIONS- ?Hypersensitivity to eggs, neomycin, or polymyxin, or life-threatening reaction to previous influenza vaccination. (4)-WARNINGS AND PRECAUTIONS- ?If Guillain-Barr 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. (5.1) ?Immunocompromised persons may have a diminished immune response to AFLURIA. (5.2)-ADVERSE REACTIONS- ? In adults, the most common (? 10%) local (injection-site) adverse reactions were tenderness, pain, redness, and swelling. The most common (? 10%) systemic adverse reactions were headache, malaise, and muscle aches. (6) ? In children, the most common (? 10%) local (injection-site) adverse reactions were pain, redness, and swelling. The most common (? 10%) systemic adverse reactions were irritability, rhinitis, fever, cough, loss of appetite, vomiting/diarrhea, headache, muscle aches and sore throat. (6)To report SUSPECTED ADVERSE REACTIONS, contact CSL Biotherapies at 1-888-435-8633 or VAERS at 1-800-822-7967 and www.vaers.hhs.gov. -DRUG INTERACTIONS- ?Do not mix with any other vaccine in the same syringe or vial. (7.1) ? Immunosuppressive therapies may diminish the immune response to AFLURIA. (7.2)-USE IN SPECIFIC POPULATIONS- ? Safety and effectiveness of AFLURIA have not been established in pregnant women or nursing mothers and in the pediatric population below 6 months of age. (8.1, 8.3, 8.4) ? Antibody responses were lower in geriatric subjects than in younger subjects. (8.5)See 17 for PATIENT COUNSELING INFORMATION. Revised: 11/2009 FULL PRESCRIBING INFORMATION: CONTENTS* 1 INDICATIONS AND USAGE 2 DOSAGE AND ADMINISTRATION 2.1 Prior to Administration 2.2 Administration 3 DOSAGE FORMS AND STRENGTHS 4 CONTRAINDICATIONS 5 WARNINGS AND PRECAUTIONS 5.1 Guillain-Barr Syndrome (GBS) 5.2 Altered Immunocompetence 5.3 Preventing and Managing Allergic Reactions 5.4 Limitations of Vaccine Effectiveness 6 ADVERSE REACTIONS 6.1 Overall Adverse Reactions 6.2 Safety Experience from Clinical Studies 6.3 Postmarketing Experience 6.4 Other Adverse Reactions Associated With Influenza Vaccination 7 DRUG INTERACTIONS 7.1 Concurrent Use With Other Vaccines 7.2 Concurrent Use With Immunosuppressive Therapies 8 USE IN SPECIFIC POPULATIONS 8.1 Pregnancy 8.3 Nursing Mothers 8.4 Pediatric Use 8.5 Geriatric Use 11 DESCRIPTION 12 CLINICAL PHARMACOLOGY 12.1