Monograph Details

Immune System > Immunization
ENGERIX-B PEDIATRIC/ADOLESCENT
Manufacturer
GlaxoSmithKline Pharmaceuticals
Legal Classification
Rx
Pharmacological Class
HB.
Generic Name
Hepatitis B vaccine (recombinant) 10micrograms/0.5mL; aluminum hydroxide adsorbed; IM inj; preservative-free; contains thimerosal (trace).
Also
ENGERIX-B ADULT
Indications
Hepatitis B immunization.
Children
Give IM in anterolateral thigh or deltoid; see literature. Infants (mothers are HBsAG negative): 10micrograms at birth and repeat 1 and 6 months later; infants (mothers are HBsAG positive) and children through age 10yrs: 10micrograms at elected date and repeat 1 and 6 months later, or 10micrograms at elected date and repeat 1, 2, and 12 months later. High risk: consider hepatitis B immune globulin also. Booster doses: when appropriate, may use 10micrograms for children age 10yrs or younger, or 20micrograms for ages 11yrs and older.
Adults
Give IM in deltoid muscle. 11–19yrs: 10micrograms at elected date and repeat 1 and 6 months later, or 20micrograms at elected date and repeat 1, 2, and 12 months later, or 20micrograms at elected date and repeat 1 and 6 months later. >19yrs: 20micrograms at elected date and repeat 1 and 6 months later, or 20 micrograms at elected date and repeat 1, 2, and 12 months later. Hemodialysis: 40micrograms at elected date and repeat 1, 2, and 6 months later. High-risk: consider hepatitis B immune globulin also. Booster dose: when appropriate, may use 20micrograms for persons 11yrs of age and older; hemodialysis patients booster dose is 40micrograms.
Contraindications
Yeast hypersensitivity.
Precautions
May defer in acute febrile illness or active infection. May be given SC only if risk of hemorrhage. Have epinephrine inj available. Multiple sclerosis. Pregnancy (Cat.C). Nursing mothers.
Adverse Reactions
Local reactions, malaise, nausea, diarrhea, rash. Anaphylaxis.
How Supplied
Pediatric/Adolescent (single-dose prefilled Tip-Lok syringe)—5 (without needles)
Pediatric/Adolescent (single-dose vials)—1, 10
Adult (single-dose prefilled Tip-Lok syringe)—5 (without needles)
Adult (single-dose vials)—1, 10, 25
Additional Resources
Related Prescribing Note