April 28, 2017
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"Patients with a past or current hepatitis B virus (HBV) infection can experience sometimes fatal HBV reactivation if they take any of nine direct-acting antivirals for hepatitis virus C (HCV) infection, the US Food and Drug Administration (FDA) a"...





Included as part of the PRECAUTIONS section.


Hypersensitivity To Latex

The vial stopper and the syringe plunger stopper and tip cap contain dry natural latex rubber, which may cause allergic reactions in latex-sensitive individuals.

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 RECOMBIVAX HB, to infants born prematurely should be based on consideration of the individual infant's medical status and the potential benefits and possible risks of vaccination. For RECOMBIVAX HB, 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 to mothers who are HBsAg positive if vaccination is delayed.

Infants Weighing Less Than 2000 g

Hepatitis B vaccination should be delayed until 1 month of age or hospital discharge in infants weighing < 2000 g if the mother is documented to be HBsAg negative at the time of the infant's birth. Infants weighing < 2000 g born to HBsAg positive or HBsAg unknown mothers should receive vaccine and hepatitis B immune globulin (HBIG) in accordance with ACIP recommendations if HBsAg status cannot be determined3 [see DOSAGE AND ADMINISTRATION].

Prevention And Management Of Allergic Vaccine Reactions

Appropriate medical treatment and supervision must be available to manage possible anaphylactic reactions following administration [see CONTRAINDICATIONS].

Limitations Of Vaccine Effectiveness

Hepatitis B virus has a long incubation period. RECOMBIVAX HB may not prevent hepatitis B infection in individuals who have an unrecognized hepatitis B infection at the time of vaccination. Additionally, vaccination with RECOMBIVAX HB may not protect all individuals.

Nonclinical Toxicology

Carcinogenesis, Mutagenesis, Impairment Of Fertility

RECOMBIVAX HB has not been evaluated for its carcinogenic or mutagenic potential, or its potential to impair fertility.

Use In Specific Populations


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

Safety and effectiveness of RECOMBIVAX HB 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 and Clinical Studies] The safety and effectiveness of RECOMBIVAX HB Dialysis Formulation in children have not been established.

Geriatric Use

Clinical studies of RECOMBIVAX HB used for licensure did not include sufficient numbers of subjects 65 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 can be expected in persons older than 60 years of age.

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

Last reviewed on RxList: 12/1/2015


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