Engerix-B

Engerix-B

WARNINGS

The vial stopper is latex-free. 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.

Hepatitis B has a long incubation period. Hepatitis B vaccination may not prevent hepatitis B infection in individuals who had an unrecognized hepatitis B infection at the time of vaccine administration. Additionally, it may not prevent infection in individuals who do not achieve protective antibody titers.

PRECAUTIONS

General

As with other vaccines, although a moderate or severe febrile illness is sufficient reason to postpone vaccination, minor illnesses such as mild upper respiratory infections with or without low-grade fever are not contraindications.17

Prior to immunization, the patient's 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 adverse event–related symptoms and/or signs in order to determine the existence of any contraindication to immunization with ENGERIX-B (hepatitis b vaccine recombinant) and to allow an assessment of benefits and risks. Epinephrine injection (1:1,000) and other appropriate agents used for the control of immediate allergic reactions must be immediately available should an acute anaphylactic reaction occur.

A separate sterile syringe and needle or a sterile disposable unit should be used for each individual patient to prevent transmission of hepatitis or other infectious agents from one person to another. Needles should be disposed of properly and should not be recapped.

Special care should be taken to prevent injection into a blood vessel.

As with any vaccine administered to immunosuppressed persons or persons receiving immunosuppressive therapy, the expected immune response may not be obtained. For individuals receiving immunosuppressive therapy, deferral of vaccination for at least 3 months after therapy may be considered.17

Multiple Sclerosis

Although no causal relationship has been established, rare instances of exacerbation of multiple sclerosis have been reported following administration of hepatitis B vaccines and other vaccines. In persons with multiple sclerosis, the benefit of immunization for prevention of hepatitis B infection and sequelae must be weighed against the risk of exacerbation of the disease.

Carcinogenesis, Mutagenesis, Impairment of Fertility

ENGERIX-B (hepatitis b vaccine recombinant) has not been evaluated for carcinogenic or mutagenic potential, or for impairment of fertility.

Pregnancy

Pregnancy Category C. Animal reproduction studies have not been conducted with ENGERIX-B (hepatitis b vaccine recombinant) . It is also not known whether ENGERIX-B (hepatitis b vaccine recombinant) can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. ENGERIX-B (hepatitis b vaccine recombinant) should be given to a pregnant woman only if clearly needed.

Nursing Mothers

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

Pediatric Use

ENGERIX-B (hepatitis b vaccine recombinant) has been shown to be 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 CLINICAL PHARMACOLOGY for seroconversion rates and titers in neonates and children. See DOSAGE AND ADMINISTRATION for recommended pediatric dosage and for recommended dosage for infants born of HBsAg-positive mothers.)

Geriatric Use

Clinical studies of ENGERIX-B (hepatitis b vaccine recombinant) did not include sufficient numbers of subjects 65 years of age and older 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 65 years of age and older than in younger individuals. Other reported clinical experience has not identified differences in overall safety between these subjects and younger adult subjects.

REFERENCES

17. Centers for Disease Control and Prevention. General Recommendations on Immunization: Recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR 1994;43(RR-1):1-38.

Last reviewed on RxList: 10/29/2009
This monograph has been modified to include the generic and brand name in many instances.

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