Engerix-B

Indications
Dosage
How Supplied

INDICATIONS

ENGERIX-B® is indicated for immunization against infection caused by all known subtypes of hepatitis B virus.

DOSAGE AND ADMINISTRATION

Preparation For Administration

Shake well before use. With thorough agitation, ENGERIX-B is a homogeneous, turbid white suspension. Do not administer if it appears otherwise. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. If either of these conditions exists, the vaccine should not be administered.

For the prefilled syringes, attach a sterile needle and administer intramuscularly.

For the vials, use a sterile needle and sterile syringe to withdraw the vaccine dose and administer intramuscularly. Changing needles between drawing vaccine from a vial and injecting it into a recipient is not necessary unless the needle has been damaged or contaminated. Use a separate sterile needle and syringe for each individual.

Administration

ENGERIX-B should be administered by intramuscular injection. The preferred administration site is the anterolateral aspect of the thigh for infants younger than 1 year and the deltoid muscle in older children (whose deltoid is large enough for an intramuscular injection) and adults. ENGERIX-B should not be administered in the gluteal region; such injections may result in suboptimal response.

ENGERIX-B may be administered subcutaneously to persons at risk of hemorrhage (e.g., hemophiliacs). However, hepatitis B vaccines administered subcutaneously are known to result in a lower antibody response. Additionally, when other aluminum-adsorbed vaccines have been administered subcutaneously, an increased incidence of local reactions including subcutaneous nodules has been observed. Therefore, subcutaneous administration should be used only in persons who are at risk of hemorrhage with intramuscular injections.

Do not administer this product intravenously or intradermally.

Recommended Dose And Schedule

Persons From Birth Through 19 Years of Age

Primary immunization for infants (born of hepatitis B surface antigen [HBsAg]-negative or HBsAg-positive mothers), children (birth through 10 years of age), and adolescents (11 through 19 years of age) consists of a series of 3 doses (0.5 mL each) given on a 0-, 1-, and 6-month schedule.

Persons 20 Years of Age and Older

Primary immunization for persons 20 years of age and older consists of a series of 3 doses (1 mL each) given on a 0-, 1-, and 6-month schedule.

Adults on Hemodialysis

Primary immunization consists of a series of 4 doses (2 mL each) given as a single 2-mL dose or two 1-mL doses on a 0-, 1-, 2-, and 6-month schedule. In hemodialysis patients, antibody response is lower than in healthy persons and protection may persist only as long as antibody levels remain above 10 mIU/mL. Therefore, the need for booster doses should be assessed by annual antibody testing. A 2-mL booster dose (as a single 2-mL dose or two 1-mL doses) should be given when antibody levels decline below 10 mIU/mL.1 [See Clinical Studies]

Table 1: Recommended Dosage and Administration Schedules

Group Dosea Schedules
Infants born of:
  HBsAg-negative mothers 0.5 mL 0, 1, 6 months
  HBsAg-positive mothersb 0.5 mL 0, 1, 6 months
Children:
  Birth through 10 years of age 0.5 mL 0, 1, 6 months
Adolescents:
  11 through 19 years of age 0.5 mL 0, 1, 6 months
Adults:
  20 years of age and older 1 mL 0, 1, 6 months
Adults on hemodialysis 2 mLc 0, 1, 2, 6 months
HBsAg = Hepatitis B surface antigen
a 0.5 mL (10 mcg); 1 mL (20 mcg).
b Infants born to HBsAg-positive mothers should also receive hepatitis B immune globulin (HBIG) [see section on Known or Presumed Exposure to Hepatitis B Virus].
c Given as a single 2-mL dose or as two 1-mL doses.

Alternate Dosing Schedules

There are alternate dosing and administration schedules which may be used for specific populations (e.g., neonates born of hepatitis B–infected mothers, persons who have or might have been recently exposed to the virus, and travelers to high-risk areas) (Table 2). For some of these alternate schedules, an additional dose at 12 months is recommended for prolonged maintenance of protective titers.

Table 2: Alternate Dosage and Administration Schedules

Group Dosea Schedules
Infants born of:
  HBsAg-positive mothersb 0.5 mL 0, 1, 2, 12 months
Children:
  Birth through 10 years of age 0.5 mL 0, 1, 2, 12 months
  5 through 10 years of age 0.5 mL 0, 12, 24 monthsc
Adolescents:
  11 through 16 years of age 0.5 mL 0, 12, 24 monthsc
  11 through 19 years of age 1 mL 0, 1, 6 months
  11 through 19 years of age 1 mL 0, 1, 2, 12 months
Adults:
  20 years of age and older 1 mL 0, 1, 2, 12 months
HBsAg = Hepatitis B surface antigen
a 0.5 mL (10 mcg); 1 mL (20 mcg).
b Infants born to HBsAg-positive mothers should also receive hepatitis B immune globulin (HBIG) [see section on Known or Presumed Exposure to Hepatitis B Virus].
c For children and adolescents for whom an extended administration schedule is acceptable based on risk of exposure.

Booster Vaccinations

Whenever administration of a booster dose is appropriate, the dose of ENGERIX-B is 0.5 mL for children 10 years of age and younger and 1 mL for persons 11 years of age and older. Studies have demonstrated a substantial increase in antibody titers after booster vaccination with ENGERIX-B. See Recommended Dose and Schedule for information on booster vaccination for adults on hemodialysis.

Known Or Presumed Exposure to Hepatitis B Virus

Persons with known or presumed exposure to the hepatitis B virus (e.g., neonates born of infected mothers, persons who experienced percutaneous or permucosal exposure to the virus) should be given hepatitis B immune globulin (HBIG) in addition to ENGERIX-B in accordance with Advisory Committee on Immunization Practices recommendations and with the package insert for HBIG. ENGERIX-B can be given on either dosing schedule (0, 1, and 6 months or 0, 1, 2, and 12 months).

HOW SUPPLIED

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 TIP-LOK® syringes
  • 1-mL (20 mcg) single-dose vials and prefilled TIP-LOK syringes [See DESCRIPTION and Storage and Handling]

Storage And Handling

ENGERIX-B is available in single-dose vials and prefilled disposable TIP-LOK syringes (packaged without needles) (Preservative Free Formulation):

10 mcg/0.5 mL Pediatric/Adolescent Dose

NDC 58160-820-01 Vial in Package of 10: NDC 58160-820-11
NDC 58160-820-43 Syringe in Package of 10: NDC 58160-820-52

20 mcg/mL Adult Dose

NDC 58160-821-01 Vial in Package of 10: NDC 58160-821-11
NDC 58160-821-05 Syringe in Package of 1: NDC 58160-821-34
NDC 58160-821-43 Syringe in Package of 10: NDC 58160-821-52

Store refrigerated between 2° and 8°C (36° and 46°F). Do not freeze; discard if product has been frozen. Do not dilute to administer.

REFERENCE

1. Centers for Disease Control and Prevention. Hepatitis B. In: Atkinson W, Wolfe C, Humiston S, Nelson R, eds. Epidemiology and Prevention of Vaccine-Preventable Diseases. 6th ed. Atlanta, GA: Public Health Foundation; 2000:207-229.

Manufactured by GlaxoSmithKline Biologicals, Rixensart, Belgium, US License No. 1617. Distributed by GlaxoSmithKline, Research Triangle Park, NC 27709. Revised: 12/2013

Last reviewed on RxList: 9/2/2014
This monograph has been modified to include the generic and brand name in many instances.

Indications
Dosage
How Supplied
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