Included as part of the PRECAUTIONS section.

Guillain-Barré Syndrome (GBS)

If 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.

Altered Immunocompetence

If AFLURIA® is administered to immunocompromised persons, including those receiving immunosuppressive therapy, the immune response may be diminished.

Preventing and Managing Allergic Reactions

Appropriate medical treatment and supervision must be available to manage possible anaphylactic reactions following administration of the vaccine.

Limitations of Vaccine Effectiveness

Vaccination with AFLURIA® may not protect all individuals.

Nonclinical Toxicology

Carcinogenesis, Mutagenesis, Impairment of Fertility

AFLURIA® has not been evaluated for carcinogenic or mutagenic potential or for impairment of fertility.

Use In Specific Populations

Pregnancy

Pregnancy Category C: Animal reproduction studies have not been conducted with AFLURIA®. It is also not known whether AFLURIA® can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. AFLURIA® should be given to a pregnant woman only if clearly needed.

Nursing Mothers

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.

Pediatric Use

Safety and effectiveness in the pediatric population have not been established.

Geriatric Use

In four clinical studies, 343 subjects ages 65 years and older received AFLURIA®. Hemagglutination-inhibiting (HI) antibody responses in geriatric subjects were lower after administration of AFLURIA® in comparison to younger adult subjects (see Clinical Studies). Adverse event rates were generally similar in frequency to those reported in subjects ages 18 to less than 65 years, although some differences were observed (see ADVERSE REACTIONS).

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