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Included as part of the PRECAUTIONS section.

Fever and Febrile Seizures

Administration of CSL's 2010 Southern Hemisphere influenza vaccine has been associated with increased postmarketing reports of fever and febrile seizures in children predominantly below the age of 5 years as compared to previous years.

Guillain-Barré Syndrome (GBS)

If GBS has occurred within 6 weeks of previous influenza vaccination, the decision to give AFLURIA (influenza virus vaccine) should be based on careful consideration of the potential benefits and risks.

Altered Immunocompetence

If AFLURIA (influenza virus vaccine) 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 (influenza virus vaccine) 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 (influenza virus vaccine) 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 (influenza virus vaccine) is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when AFLURIA (influenza virus vaccine) is administered to a nursing woman.

Pediatric Use

Safety and effectiveness of AFLURIA in children below 6 months of age have not been established. The safety and immunogenicity of AFLURIA (influenza virus vaccine) was evaluated in 298 children between the ages of 6 months and 9 years (Study 4). In this study the incidence of fever in children 6 months to < 3 years of age following the first and second doses of AFLURIA (influenza virus vaccine) was 23%. Among children 3 years to < 9 years of age the incidence was 16% following the first dose and 8% following the second dose. Administration of CSL's 2010 Southern Hemisphere influenza vaccine has been associated with increased postmarketing reports of fever and febrile seizures in children predominantly below the age of 5 years as compared to previous years (see ADVERSE REACTIONS).

Geriatric Use

In four clinical studies, 343 subjects ages 65 years and older received AFLURIA (influenza virus vaccine) . Hemagglutination-inhibiting antibody responses in geriatric subjects were lower after administration of AFLURIA (influenza virus vaccine) 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).

Last reviewed on RxList: 12/8/2010
This monograph has been modified to include the generic and brand name in many instances.