If Guillain-Barré syndrome has occurred within 6 weeks of receipt of prior influenza vaccine, the decision to give FLUARIX or any influenza vaccine should be based on careful consideration of the potential benefits and possible risks.³

As with other intramuscular injections, FLUARIX should not be given to individuals with bleeding disorders such as hemophilia or thrombocytopenia, or to persons on anticoagulant therapy unless the potential benefit clearly outweighs the risk of administration. If the decision is made to administer FLUARIX to such persons, it should be given with caution with steps taken to avoid the risk of hematoma following the injection.

Vaccination with FLUARIX may not protect 100% of susceptible individuals.

The tip cap and the rubber plunger of the needleless prefilled syringes contain dry natural latex rubber that may cause allergic reactions in latex sensitive individuals.

The ACIP has published guidelines for vaccination of persons with recent or acute illness (www.cdc.gov/nip).³

General: Do not administer by intravascular injection.

Prior to immunization of FLUARIX, the patient's current health status and medical history should be reviewed. The physician should review the patient's immunization history for possible vaccine sensitivity, previous vaccination-related adverse reactions and occurrence of any adverse event-related symptoms and/or signs, in order to determine the existence of any contraindication to immunization with FLUARIX and to allow an assessment of benefits and risks. Appropriate medical treatment and supervision should be readily available for immediate use in case of a rare anaphylactic reaction following the administration of the vaccine. Epinephrine injection (1:1,000) and other appropriate agents used for the control of immediate allergic reactions must be immediately available.

A separate, sterile syringe and needle or a sterile disposable unit should be used for each patient to prevent transmission of other infectious agents from person to person. Needles should be disposed of properly and should not be recapped.

Influenza virus is remarkable in that minor antigenic changes occur frequently (antigenic drift), whereas a significant antigenic change leading to a pandemic strain (antigenic shift) is unpredictable. FLUARIX is not effective against all possible strains of influenza virus. Protection is limited to those strains of virus from which the vaccine is prepared and to closely related strains.

As with any vaccine, if administered to immunosuppressed persons, including individuals receiving immunosuppressive therapy, the expected immune response may not be obtained.

Carcinogenesis, Mutagenesis, Impairment of Fertility: FLUARIX has not been evaluated for carcinogenic or mutagenic potential, or for impairment of fertility.

Pregnancy: Pregnancy Category C. Animal reproduction studies have not been conducted with FLUARIX. It is not known whether FLUARIX can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. FLUARIX should be given to a pregnant woman only if clearly needed. The ACIP has issued recommendations regarding the use of the influenza virus vaccine in pregnant women.³

Nursing Mothers: It is not known whether FLUARIX is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when FLUARIX is administered to a nursing woman. The ACIP has issued recommendations regarding the use of the influenza virus vaccine in nursing mothers.³

Pediatric Use: FLUARIX IS NOT INDICATED FOR USE IN CHILDREN.

Geriatric Use: FLUARIX was administered to 246 subjects ≥ 65 years of age in 3 European studies (see CLINICAL PHARMACOLOGY). Solicited adverse events were similar in type and frequency to those reported in younger subjects (see ADVERSE REACTIONS).

REFERENCES

3. Centers for Disease Control and Prevention. Prevention and control of influenza: Recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR 2004;53(RR-6):1-44.

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