Engerix-b Adult Generic Name & Formulations
Legal Class
Rx
General Description
Hepatitis B vaccine (recombinant) 20mcg/mL; aluminum hydroxide adsorbed; IM inj; preservative-free; contains thimerosal (trace).
Pharmacological Class
HB.
See Also
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
Manufacturer
Engerix-b Adult Indications
Indications
Hepatitis B immunization.
Engerix-b Adult Dosage and Administration
Adult
Give IM in deltoid muscle. 11–19yrs: 10mcg at elected date and repeat 1 and 6 months later, or 20mcg at elected date and repeat 1, 2, and 12 months later, or 20mcg at elected date and repeat 1 and 6 months later. >19yrs: 20mcg at elected date and repeat 1 and 6 months later, or 20mcg at elected date and repeat 1, 2, and 12 months later. Hemodialysis: 40mcg 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 20mcg for persons 11yrs of age and older; hemodialysis patients booster dose is 40mcg.
Children
Give IM in anterolateral thigh or deltoid; see literature. Infants (mothers are HBsAG negative): 10mcg at birth and repeat 1 and 6 months later; infants (mothers are HBsAG positive) and children through age 10yrs: 10mcg at elected date and repeat 1 and 6 months later, or 10mcg 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 10mcg for children age 10yrs or younger, or 20mcg for ages 11yrs and older.
Engerix-b Adult Contraindications
Contraindications
Yeast hypersensitivity.
Engerix-b Adult Boxed Warnings
Not Applicable
Engerix-b Adult Warnings/Precautions
Warnings/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.
Engerix-b Adult Pharmacokinetics
See Literature
Engerix-b Adult Interactions
Engerix-b Adult Adverse Reactions
Adverse Reactions
Local reactions, malaise, nausea, diarrhea, rash. Anaphylaxis.
Engerix-b Adult Clinical Trials
See Literature
Engerix-b Adult Note
Not Applicable
Engerix-b Adult Patient Counseling
See Literature