ENGERIX-B (Page 4 of 5)

Reporting Adverse Events:

The National Childhood Vaccine Injury Act requires that the manufacturer and lot number of the vaccine administered be recorded by the healthcare provider in the vaccine recipient’s permanent medical record, along with the date of administration of the vaccine and the name, address, and title of the person administering the vaccine.18 The Act further requires the healthcare provider to report to the US Department of Health and Human Services via VAERS the occurrence following immunization of any event set forth in the Vaccine Injury Table including: Anaphylaxis or anaphylactic shock within 4 hours, encephalopathy or encephalitis within 72 hours, or any sequelae thereof (including death).18,19 In addition, any event considered a contraindication to further doses should be reported. The VAERS toll-free number is 1-800-822-7967.

DOSAGE AND ADMINISTRATION

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

a Two × 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

a This 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.

b 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 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.

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