November 26, 2015




Included as part of the PRECAUTIONS section.



The tip caps of the prefilled syringes may contain natural rubber latex which may cause allergic reactions in latex-sensitive individuals.


Syncope (fainting) can occur in association with administration of injectable vaccines, including ENGERIX-B. Syncope can be accompanied by transient neurological signs such as visual disturbance, paresthesia, and tonic-clonic limb movements. Procedures should be in place to avoid falling injury and to restore cerebral perfusion following syncope.

Infants Weighing Less than 2,000 g At Birth

Hepatitis B vaccine should be deferred for infants with a birth weight < 2,000 g if the mother is documented to be HBsAg negative at the time of the infant's birth. Vaccination can commence at chronological age 1 month or hospital discharge. Infants born weighing < 2,000 g to HBsAg- positive mothers should receive vaccine and hepatitis B immune globulin (HBIG) within 12 hours after birth. Infants born weighing < 2,000 g to mothers of unknown HBsAg status should receive vaccine and HBIG within 12 hours after birth if the mother's HBsAg status cannot be determined within the first 12 hours of life. The birth dose in infants born weighing < 2,000 g should not be counted as the first dose in the vaccine series and it should be followed with a full 3-dose standard regimen (total of 4 doses).2 [See DOSAGE AND ADMINISTRATION.]

Apnea In Premature Infants

Apnea following intramuscular vaccination has been observed in some infants born prematurely. Decisions about when to administer an intramuscular vaccine, including ENGERIX-B, to infants born prematurely should be based on consideration of the infant's medical status, and the potential benefits and possible risks of vaccination. For ENGERIX-B, this assessment should include consideration of the mother's hepatitis B antigen status and the high probability of maternal transmission of hepatitis B virus to infants born of mothers who are HBsAg positive if vaccination is delayed.

Preventing And Managing Allergic Vaccine Reactions

Prior to immunization, the healthcare provider should review the immunization history for possible vaccine sensitivity and previous vaccination-related adverse reactions to allow an assessment of benefits and risks. Epinephrine and other appropriate agents used for the control of immediate allergic reactions must be immediately available should an acute anaphylactic reaction occur. [See CONTRAINDICATIONS]

Moderate Or Severe Acute Illness

To avoid diagnostic confusion between manifestations of an acute illness and possible vaccine adverse effects, vaccination with ENGERIX-B should be postponed in persons with moderate or severe acute febrile illness unless they are at immediate risk of hepatitis B infection (e.g., infants born of HBsAg-positive mothers).

Altered Immunocompetence

Immunocompromised persons may have a diminished immune response to ENGERIX-B, including individuals receiving immunosuppressant therapy.

Multiple Sclerosis

Results from 2 clinical studies indicate that there is no association between hepatitis B vaccination and the development of multiple sclerosis3, and that vaccination with hepatitis B vaccine does not appear to increase the short-term risk of relapse in multiple sclerosis.4

Limitations Of Vaccine Effectiveness

Hepatitis B has a long incubation period. ENGERIX-B 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.

Nonclinical Toxicology

Carcinogenesis, Mutagenesis, Impairment Of Fertility

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

Use In Specific Populations


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

Safety and effectiveness of ENGERIX-B have been established in all pediatric age groups. Maternally transferred antibodies do not interfere with the active immune response to the vaccine. [See ADVERSE REACTIONS, Clinical Studies]

The timing of the first dose in infants weighing less than 2,000 g at birth depends on the HBsAg status of the mother. [See WARNINGS AND PRECAUTIONS]

Geriatric Use

Clinical studies of ENGERIX-B used for licensure did not include sufficient numbers of subjects years of age and older to determine whether they respond differently from younger subjects. However, in later studies it has been shown that a diminished antibody response and seroprotective levels can be expected in persons older than 60 years of age.5 [See Clinical Studies]


2. Centers for Disease Control and Prevention. A Comprehensive Immunization Strategy to Eliminate Transmission of Hepatitis B Virus Infection in the United States. Recommendations of the Advisory Committee on Immunization Practices (ACIP). Part 1: Immunization of Infants, Children, and Adolescents, MMWR 2005;54(RR-16);1-23.

3.. Ascherio A, Zhang SM, Hernan MA, et al. Hepatitis B vaccination and the risk of multiple sclerosis. NEngl JMed. 2001;344(5):327-332.

4. Confavreux C, Suissa S, Saddier P, et al. Vaccination and the risk of relapse in multiple sclerosis. N Engl J Med. 2001-344(5):319-326.

5. Centers for Disease Control and Prevention. A Comprehensive Immunization Strategy to Eliminate Transmission of Hepatitis B Virus Infection in the United States. Recommendations of the Advisory Committee on Immunization Practices (ACIP). Part 2: Immunization of Adults, MMWR 2006;55(RR-16);1-25.

This monograph has been modified to include the generic and brand name in many instances.

Last reviewed on RxList: 11/16/2015


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.

Women's Health

Find out what women really need.