Engerix-b

Injection:

ENGERIX-B should be administered by intramuscular injection. Do not inject intravenously or intradermally. In adults, the injection should be given in the deltoid region but it may be preferable to inject in the anterolateral thigh in neonates and infants, who have smaller deltoid muscles. ENGERIX-B should not be administered in the gluteal region; such injections may result in suboptimal response. The attending physician should determine final selection of the injection site and needle size, depending upon the patient's age and the size of the target muscle. A 1-inch, 23-gauge needle is sufficient to penetrate the anterolateral thigh in infants younger than 12 months of age. A 5/8-inch, 25-gauge needle may be used to administer the vaccine in the deltoid region of toddlers and children up to, and including, 10 years of age. The 1-inch, 23-gauge needle is appropriate for use in older children and adults.17

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 lower GMTs. 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.

Preparation for Administration: 

Shake well before withdrawal and use. Inspect ENGERIX-B visually for particulate matter, discoloration and cracks in the vial or syringe prior to administration, whenever solution and container permit. If any of these conditions exist, the vaccine should not be administered. With thorough agitation, ENGERIX-B is a slightly turbid white suspension. Discard if it appears otherwise. The vaccine should be used as supplied; no dilution is necessary. The full recommended dose of the vaccine should be used. Any vaccine remaining in a single-dose vial should be discarded.

Dosing Schedules:

The usual immunization regimen (see Table 1) consists of 3 doses of vaccine given according to the following schedule: first dose: at elected date; second dose: 1 month later; third dose: 6 months after first dose.

Table 1. Recommended Dosage and Administration Schedules Group Dose Schedules Infants born of: HBsAg-negative mothers 10 mcg/0.5 mL 0, 1, 6 months HBsAg-positive mothers 10 mcg/0.5 mL 0, 1, 6 months Children: Birth through 10 years of age 10 mcg/0.5 mL 0, 1, 6 months Adolescents: 11 through 19 years of age 10 mcg/0.5 mL 0, 1, 6 months Adults (>19 years) 20 mcg/1.0 mL 0, 1, 6 months Adult hemodialysis 40 mcg/2.0 mLa 0, 1, 2, 6 months

 aTwo × 20 mcg in 1 or 2 injections.

For hemodialysis patients, in whom vaccine-induced protection is less complete and may persist only as long as antibody levels remain above 10 mIU/mL, the need for booster doses should be assessed by annual antibody testing. 40 mcg (2 × 20 mcg) booster doses with ENGERIX-B should be given when antibody levels decline below 10 mIU/mL.1 Data show individuals given a booster with ENGERIX-B achieve high antibody titers. (See CLINICAL PHARMACOLOGY.)

There are alternate dosing and administration schedules which may be used for specific populations (see Table 2 and accompanying explanations).

Table 2. Alternate Dosage and Administration Schedules Group Dose Schedules Infants born of: HBsAg-positive mothers 10 mcg/0.5 mL 0, 1, 2, 12 monthsa Children: Birth through 10 years of age 10 mcg/0.5 mL 0, 1, 2, 12 monthsa 5 through 10 years of age 10 mcg/0.5 mL 0, 12, 24 monthsb Adolescents: 11 through 16 years of age 10 mcg/0.5 mL 0, 12, 24 monthsb 11 through 19 years of age 20 mcg/1.0 mL 0, 1, 6 months 11 through 19 years of age 20 mcg/1.0 mL 0, 1, 2, 12 monthsa Adults (>19 years) 20 mcg/1.0 mL 0, 1, 2, 12 monthsa

 aThis schedule is designed for certain populations (e.g., neonates born of hepatitis B–infected mothers, others who have or might have been recently exposed to the virus, certain travelers to high-risk areas. See INDICATIONS AND USAGE). On this alternate schedule, an additional dose at 12 months is recommended for prolonged maintenance of protective titers.

bFor 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 10 mcg for children 10 years of age and younger, 20 mcg for adolescents 11 through 19 years of age, and 20 mcg for adults. Studies have demonstrated a substantial increase in antibody titers after ENGERIX-B booster vaccination following an initial course with both plasma- and yeast-derived vaccines. (See CLINICAL PHARMACOLOGY.)

See previous section for discussion on booster vaccination for adult hemodialysis patients.

Known or Presumed Exposure to Hepatitis B Virus:

Unprotected individuals with known or presumed exposure to the hepatitis B virus (e.g., neonates born of infected mothers, others experiencing percutaneous or permucosal exposure) should be given hepatitis B immune globulin (HBIG) in addition to ENGERIX-B in accordance with ACIP recommendations1 and with the package insert for HBIG. ENGERIX-B can be given on either dosing schedule (see above).

For intramuscular administration. See Section 2.2 for subcutaneous administration in persons at risk of hemorrhage.

2.1 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.

2.2 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.

2.3 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 (14.2).]

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 receive vaccine and hepatitis B immune globulin (HBIG) within 12 hours after birth [see Dosage and Administration (2.6)].

c Given as a single 2-mL dose or as two 1-mL doses.

2.4 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 receive vaccine and hepatitis B immune globulin (HBIG) within 12 hours after birth [see Dosage and Administration (2.6)].

c For children and adolescents for whom an extended administration schedule is acceptable based on risk of exposure.

2.5 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 Section 2.3 for information on booster vaccination for adults on hemodialysis.

2.6 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).