Recombivax

WARNINGS

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

Because of the long incubation period for hepatitis B, it is possible for unrecognized infection to be present at the time the vaccine is given. The vaccine may not prevent hepatitis B in such patients.

PRECAUTIONS

General

As with any percutaneous vaccine, epinephrine (1:1000) should be available for immediate use should an anaphylactoid reaction occur.

Any serious active infection including febrile illness is reason for delaying use of the vaccine except when in the opinion of the physician, withholding the vaccine entails a greater risk.

Caution and appropriate care should be exercised in administering the vaccine to individuals with severely compromised cardiopulmonary status or to others in whom a febrile or systemic reaction could pose a significant risk.

Instructions to Healthcare Provider

The healthcare provider should determine the current health status and previous vaccination history of the vaccinee.

The healthcare provider should question the patient, parent or guardian about reactions to a previous dose of RECOMBIVAX (hepatitis b vaccine (recombinant)) HB or other hepatitis B vaccines.

The healthcare provider must record in the patient's permanent record: the manufacturer, lot number, date of administration, and the name and address of the person administering the vaccine.

Injection of a blood vessel should be avoided.

Information for Vaccine Recipients and Parents/Guardians

The healthcare provider should provide the vaccine information required to be given with each vaccination to the patient, parent or guardian.

The healthcare provider should inform the patient, parent or guardian of the benefits and risks associated with vaccination, as well as the importance of completing the immunization series. For risks associated with vaccination, see WARNINGS, PRECAUTIONS, and ADVERSE REACTIONS.

Patients, parents and guardians should be instructed to report any serious adverse reactions to their healthcare provider, who in turn should report such events to the U.S. Department of Health and Human Services through the Vaccine Adverse Event Reporting System (VAERS), 1-800-822-7967.31 The healthcare provider should inform the parent or guardian of the National Vaccine Injury Compensation Program (NVICP), 1-800-338-2382.

Carcinogenesis, Mutagenesis, Impairment of Fertility

RECOMBIVAX (hepatitis b vaccine (recombinant)) HB 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 the vaccine. It is also not known whether the vaccine can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. The vaccine should be given to a pregnant woman only if clearly needed.

Nursing Mothers

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

Pediatric Use

RECOMBIVAX (hepatitis b vaccine (recombinant)) HB has been shown to be usually well-tolerated and highly immunogenic in infants and children of all ages. Newborns also respond well; maternally transferred antibodies do not interfere with the active immune response to the vaccine. See DOSAGE AND ADMINISTRATION for recommended pediatric dosage and for recommended dosage for infants born to HBsAg positive mothers.

The safety and effectiveness of RECOMBIVAX (hepatitis b vaccine (recombinant)) HB Dialysis Formulation in children have not been established.

Geriatric Use

Clinical studies of RECOMBIVAX (hepatitis b vaccine (recombinant)) HB did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reports from the clinical literature indicate that hepatitis B vaccines are less immunogenic in adults aged 65 years or older than in younger individuals.32 No overall differences in safety were observed between these subjects and younger subjects.

REFERENCES

10. Data on file at Merck Research Laboratories.

31. Vaccine Adverse Event Reporting System - United States. MMWR 39(41): 730-733, October 19, 1990.

32. Zajac, B.A.; West, D.J.; McAleer, W.J.; Scolnick, E.M.: Overview of Clinical Studies with Hepatitis B Vaccine Made by Recombinant DNA, J. Infection, 13(Sup. A): 39-45, July 1986.

Last reviewed on RxList: 9/2/2008
This monograph has been modified to include the generic and brand name in many instances.

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