Indications and Usage
ENGERIX-B is a vaccine indicated for immunization against infection caused by all known subtypes of hepatitis B virus.
Dosage and Administration
- ENGERIX-B is administered by intramuscular injection.
- Persons from birth through 19 years of age: A series of 3 doses (0.5 mL each) given on a 0-, 1-, 6-month schedule.
- Persons 20 years of age and older: A series of 3 doses (1 mL each) given on a 0-, 1-, 6-month schedule.
- Adults on hemodialysis: A series of 4 doses (2 mL each) given as a single 2-mL dose or as two 1-mL doses on a 0-, 1-, 2-, 6-month schedule.
Dosage Forms and Strengths
ENGERIX-B is a sterile suspension available in the following presentations:
- 0.5-mL (10 mcg) single-dose vials and prefilled syringes (3)
- 1-mL (20 mcg) single-dose vials and prefilled syringes (3)
Severe allergic reaction (e.g., anaphylaxis) after a previous dose of any hepatitis B-containing vaccine, or to any component of ENGERIX-B, including yeast.
Warnings and Precaution
- ENGERIX-B is available in vials and 2 types of prefilled syringes. One type of prefilled syringe has a tip cap which may contain natural rubber latex. The other type has a tip cap and a rubber plunger which contain dry natural latex rubber. Use of these syringes may cause allergic reactions in latex-sensitive individuals.
- Syncope (fainting) can occur in association with administration of injectable vaccines, including ENGERIX-B. Procedures should be in place to avoid falling injury and to restore cerebral perfusion following syncope.
- 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.
The most common solicited adverse events were injection-site soreness (22%) and fatigue (14%).
Use in Specific Populations
- Safety has not been established in pregnant women. ENGERIX-B should only be given to a pregnant woman if clearly needed.
- Antibody responses are lower in persons older than 60 years of age than in younger adults.