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Vaqta

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Vaqta

Vaqta

WARNINGS

The vial stopper and the syringe plunger stopper contain dry natural latex rubber that may cause allergic reactions in latex sensitive individuals.

Individuals who develop symptoms suggestive of hypersensitivity after an injection of hepatitis A vaccine should not receive further injections of the vaccine (see CONTRAINDICATIONS).

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

PRECAUTIONS

General

Epinephrine injection (1:1000) and other appropriate agents used for the control of immediate allergic reactions must be immediately available should an acute anaphylactic reaction occur.

VAQTA (hepatitis a vaccine, inactivated) 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 other intramuscular injections, VAQTA (hepatitis a vaccine, inactivated) should not be given to individuals with bleeding disorders such as hemophilia or thrombocytopenia, or to persons on anticoagulant therapy unless the potential benefits clearly outweigh the risk of administration. If the decision is made to administer VAQTA (hepatitis a vaccine, inactivated) to such persons, it should be given with caution with steps taken to avoid the risk of hematoma following the injection.8

As with any vaccine, vaccination with VAQTA (hepatitis a vaccine, inactivated) 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 (hepatitis a vaccine, inactivated) except when, in the opinion of the physician, withholding the vaccine entails a greater risk.

Information for Vaccine Recipients and Parents or Guardians

Patients, parents or guardians should be informed by the healthcare provider of the potential benefits and risks of the vaccine. It is important that the vaccine recipient, parent or guardian be questioned concerning occurrence of any symptoms and/or signs of an adverse reaction after a previous dose of hepatitis A vaccine. The healthcare provider should inform the patients, parents or guardians about the potential for adverse events that have been temporally associated with administration of VAQTA (hepatitis a vaccine, inactivated) . The patient, or parent or guardian accompanying the recipient, should be told to report severe or unusual adverse events to the physician or clinic where the vaccine was administered.

The patient, parent or guardian should be given the Vaccine Information Statements, which are required by the National Childhood Vaccine Injury Act of 1986 to be given prior to immunization. These materials are available free of charge at the Centers for Disease Control and Prevention (CDC) website (www.cdc.gov/nip). The United States Department of Health and Human Services has established a Vaccine Adverse Event Reporting System (VAERS) to accept all reports of suspected adverse events after the administration of any vaccine, including but not limited to the reporting of events required by the National Childhood Vaccine Injury Act of 1986. The VAERS toll-free number is 1-800-822-7967. Reporting forms may also be obtained at the VAERS website at www.vaers.org.8

Carcinogenesis, Mutagenesis, Impairment of Fertility

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

Nursing Mothers

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

Pediatric Use

The safety of VAQTA (hepatitis a vaccine, inactivated) has been evaluated in 706 children 12 through 23 months of age, and 2615 children/adolescents 2 through 18 years of age. (See ADVERSE REACTIONS and DOSAGE AND ADMINISTRATION.)

Safety and effectiveness in infants below 12 months of age have not been established.

Geriatric Use

Of the total number of adults in clinical studies of VAQTA (hepatitis a vaccine, inactivated) , 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.

REFERENCES

8. Recommendations of the Advisory Committee on Immunization Practices (ACIP); General Recommendations on Immunization, MMWR 51(RR-2): 1-35, 2002.

9. Recommendations of the Advisory Committee on Immunization Practices (ACIP); Prevention of Hepatitis A Through Active or Passive Immunization, MMWR 42(RR-4): 1-18, 1993.

Last reviewed on RxList: 3/5/2009
This monograph has been modified to include the generic and brand name in many instances.

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Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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