There have been rare reports of anaphylaxis/anaphylactoid reactions following commercial use of the vaccine.

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 vial stopper is latex-free.

Hepatitis A has a relatively long incubation period (15 to 50 days). Hepatitis A vaccine may not prevent hepatitis A infection in individuals who have an unrecognized hepatitis A infection at the time of vaccination. Additionally, it may not prevent infection in individuals who do not achieve protective antibody titers (although the lowest titer needed to confer protection has not been determined).

General: Prior to immunization with HAVRIX, 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 advers-eevent-related symptoms and/or signs, in order to determine the existence of any contraindication to immunization with HAVRIX 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 the transmission of other infectious agents from person to person. Needles should be disposed of properly and should not be recapped.

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: HAVRIX has not been evaluated for its carcinogenic potential, mutagenic potential, or potential for impairment of fertility.

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

Nursing Mothers: It is not known whether HAVRIX is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when HAVRIX is administered to a nursing woman.

Pediatric Use: The safety and effectiveness of HAVRIX have been evaluated in 20,436 subjects 1 year to 18 years of age. (See CLINICAL PHARMACOLOGY for immunogenicity and efficacy data. See DOSAGE AND ADMINISTRATION for recommended dosage.)

The safety and effectiveness of HAVRIX have not been established in subjects less than 12 months of age.

Geriatric Use: Clinical studies of HAVRIX did not include sufficient numbers of subjects 65 years of age and older to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in overall safety between these subjects and younger adult subjects.

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