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Engerix-B (Hepatitis B Vaccine (Recombinant)) - Warnings and Precautions



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.



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 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

The potential risk of apnea and the need for respiratory monitoring for 48 to 72 hours should be considered when administering the primary immunization series to very premature infants (born ≤28 weeks of gestation) who remain hospitalized at the time of vaccination and particularly for those with a previous history of respiratory immaturity. It is generally understood that the benefit of vaccination is high in very premature infants. The decision to vaccinate should be based on careful consideration of the potential benefits and possible risks.

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.

Information for the Patient:

Patients, parents, or guardians should be informed of the potential benefits and risks of the vaccine, and of the importance of completing the immunization series. As with any vaccine, it is important when a subject returns for the next dose in a series that he or she be questioned concerning occurrence of any symptoms and/or signs of an adverse reaction after a previous dose of the same vaccine. Patients, parents, or guardians should be told to report severe or unusual adverse reactions to their healthcare provider.

The parent or guardian should be given the Vaccine Information Materials, which are required by the National Childhood Vaccine Injury Act of 1986 to be given prior to immunization.

Drug Interactions:

For information regarding simultaneous administration with other vaccines, refer to INDICATIONS AND USAGE.

Carcinogenesis, Mutagenesis, Impairment of Fertility:

ENGERIX-B has not been evaluated for carcinogenic or mutagenic potential, or for impairment of fertility.


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

Nursing Mothers:

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

Pediatric Use:

ENGERIX-B 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 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.

Page last updated: 2010-03-02

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