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Included as part of the PRECAUTIONS section.

Latex

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.

Altered Immunocompetence

Immunocompromised persons may have a diminished immune response to HAVRIX (hepatitis a vaccine, inactivated) , including individuals receiving immunosuppressant therapy.

Limitations of Vaccine Effectiveness

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).

Preventing and Managing Allergic Vaccine Reactions

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

Nonclinical Toxicology

Carcinogenesis, Mutagenesis, Impairment of Fertility

HAVRIX (hepatitis a vaccine, inactivated) has not been evaluated for its carcinogenic potential, mutagenic potential, or potential for impairment of fertility.

Use In Specific Populations

Pregnancy

Pregnancy Category C

Animal reproduction studies have not been conducted with HAVRIX (hepatitis a vaccine, inactivated) . It is also not known whether HAVRIX (hepatitis a vaccine, inactivated) can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. HAVRIX (hepatitis a vaccine, inactivated) should be given to a pregnant woman only if clearly needed.

Nursing Mothers

It is not known whether HAVRIX (hepatitis a vaccine, inactivated) is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when HAVRIX (hepatitis a vaccine, inactivated) is administered to a nursing woman.

Pediatric Use

The safety and effectiveness of HAVRIX (hepatitis a vaccine, inactivated) have been evaluated in 20,869 subjects 1 year to 18 years of age.

The safety and effectiveness of HAVRIX (hepatitis a vaccine, inactivated) have not been established in subjects younger than 12 months of age.

Geriatric Use

Clinical studies of HAVRIX (hepatitis a vaccine, inactivated) 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.

Hepatic Impairment

Subjects with chronic liver disease had a lower antibody response to HAVRIX than healthy subjects [see Clinical Studies].

Last reviewed on RxList: 10/20/2008
This monograph has been modified to include the generic and brand name in many instances.