WARNINGS
Individuals who develop symptoms suggestive of hypersensitivity after an injection of VAQTA should not receive further injections of the vaccine (see CONTRAINDICATIONS).
If VAQTA is used in individuals with malignancies or those receiving immunosuppressive therapy or who are otherwise immunocompromised, the expected immune response may not be obtained.
PRECAUTIONS
General
VAQTA will not prevent hepatitis caused by infectious agents other than hepatitis A virus. Because of the long incubation period (approximately 20 to 50 days) for hepatitis A, it is possible for unrecognized hepatitis A infection to be present at the time the vaccine is given. The vaccine may not prevent hepatitis A in such individuals.
As with any vaccine, adequate treatment provisions, including epinephrine, should be available for immediate use should an anaphylactic or anaphylactoid reaction occur.
VAQTA should be administered with caution to people with bleeding disorders who are at risk of hemorrhage following intramuscular injection (see DOSAGE AND ADMINISTRATION).
As with any vaccine, vaccination with VAQTA may not result in a protective response in all susceptible vaccinees.
An acute infection or febrile illness may be reason for delaying use of VAQTA except when, in the opinion of the physician, withholding the vaccine entails a greater risk.
Carcinogenesis, Mutagenesis, Impairment of Fertility
VAQTA has not been evaluated for its carcinogenic or mutagenic potential, or its potential to impair fertility.
Pregnancy Pregnancy Category C: Animal reproduction studies have not been conducted with VAQTA. It is also not known whether VAQTA can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. VAQTA should be given to a pregnant woman only if clearly needed. Nursing Mothers
It is not known whether VAQTA is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when VAQTA is administered to a woman who is breast feeding.
Pediatric Use
VAQTA has been shown to be generally well tolerated and highly immunogenic in individuals 2 through 18 years of age. See DOSAGE AND ADMINISTRATION for the recommended dosage schedule.
Safety and effectiveness in infants below 2 years of age have not been established. Geriatric Use
Of the total number of adults in clinical studies of VAQTA, conducted pre- and post-licensure, 68 were 65 years of age or older, 10 of whom were 75 years of age or older. No overall differences in safety and immunogenicity were observed between these subjects and younger subjects; however, greater sensitivity of some older individuals cannot be ruled out. In a large post-marketing safety study in 42,110 individuals, >/=2 years of age, 4769 were 65 years of age or older, 1073 of whom were 75 years of age or older. There were no adverse experiences judged by the investigator to be vaccine related in the geriatric study population. Other reported clinical experience has not identified differences in responses between the elderly and younger subjects.
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