DOSAGE AND ADMINISTRATION
DO NOT INJECT INTRAVENOUSLY OR INTRADERMALLY.
RECOMBIVAX HB Hepatitis B Vaccine (Recombinant) DIALYSIS FORMULATION [(40 mcg/mL) (WITHOUT PRESERVATIVE)] IS INTENDED ONLY FOR ADULT PREDIALYSIS/DIALYSIS PATIENTS. RECOMBIVAX HB Hepatitis B Vaccine (Recombinant) PEDIATRIC/ADOLESCENT (WITHOUT PRESERVATIVE) and ADULT FORMULATIONS (WITHOUT PRESERVATIVE) ARE NOT INTENDED FOR USE IN PREDIALYSIS/DIALYSIS PATIENTS. Three-Dose Regimen
The vaccination regimen for each population 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 the first dose
For infants born of mothers who are HBsAg positive or mothers of unknown HBsAg status, treatment recommendations are described in the subsection titled: Guidelines For Treatment of Infants Born of HBsAg Positive Mothers or Mothers of Unknown HBsAg Status. Two-Dose Regimen--Adolescents (11 through 15 years of age)
An alternate two-dose regimen is available for routine vaccination of adolescents (11 to 15 years of age). The regimen consists of two doses of vaccine (10 mcg) given according to the following schedule:
First injection: at elected date
Second dose: 4-6 months later
Table 1 summarizes the dose and formulation of RECOMBIVAX HB for specific populations, regardless of the risk of infection with hepatitis B virus.
Table 1
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Group
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Dose/Regimen
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Formulation
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Color Code
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Infants, Children, and
Adolescents
0-19 years of age
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5 mcg (0.5 mL)
3 × 5 mcg
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Pediatric/Adolescent
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Yellow
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Adolescents #
11 through 15 years of age
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10 mcg ** (1.0 mL)
2 × 10 mcg
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Adult
|
Green
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Adults
>/=20 years of age
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10 mcg ** (1.0 mL)
3 × 10 mcg
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Adult
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Green
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Predialysis and
Dialysis Patients **/*
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40 mcg (1.0 mL)
3 × 40 mcg
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Dialysis
|
Blue
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**If the suggested formulation is not available, the appropriate dosage can be achieved from another formulation provided that the total volume of vaccine administered does not exceed 1 mL. However, the Dialysis Formulation may be used only for adult predialysis/dialysis patients. |
| #Adolescents (11 through 15 years of age) may receive either regimen: the 3 × 5 mcg (Pediatric/Adolescent Formulation) or the 2 × 10 mcg (Adult Formulation). |
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**/* See also recommendations for revaccination of predialysis and dialysis patients in DOSAGE AND ADMINISTRATION, Revaccination.
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RECOMBIVAX HB is for intramuscular injection. The deltoid muscle is the preferred site for intramuscular injection in adults. Data suggests that injections given in the buttocks frequently are given into fatty tissue instead of into muscle. Such injections have resulted in a lower seroconversion rate than was expected. The anterolateral thigh is the recommended site for intramuscular injection in infants and young children.
For persons at risk of hemorrhage following intramuscular injection, RECOMBIVAX HB may be administered subcutaneously. However, 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 (e.g., hemophiliacs) who are at risk of hemorrhage following intramuscular injections.
The vaccine should be used as supplied; no dilution or reconstitution is necessary. The full recommended dose of the vaccine should be used. For All Formulations: Since none of the formulations contain a preservative, once the single-dose vial has been penetrated, the withdrawn vaccine should be used promptly, and the vial must be discarded.
Shake well before use. Thorough agitation at the time of administration is necessary to maintain suspension of the vaccine.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration. After thorough agitation, the vaccine is a slightly opaque, white suspension.
Withdraw the recommended dose from the vial using a sterile needle and syringe free of preservatives, antiseptics, and detergents.
It is important to use a separate sterile syringe and needle for each individual patient to prevent transmission of hepatitis and other infectious agents from one person to another. Needles should be disposed of properly and should not be recapped.
Injection must be accomplished with a needle long enough to ensure intramuscular deposition of the vaccine.
Guidelines For Treatment of Infants Born of HBsAg Positive Mothers or Mothers of Unknown HBsAg Status
Each infant should receive three 5 mcg doses of RECOMBIVAX HB irrespective of the mother's HBsAg status (see Table 1). The ACIP recommends that if the mother is determined to be HBsAg positive within 7 days of delivery, the infant also should be given a dose of HBIG (0.5 mL) immediately. The first dose of RECOMBIVAX HB may be given at the same time as HBIG, but it should be administered in the opposite anterolateral thigh.
Revaccination
The duration of the protective effect of RECOMBIVAX HB in healthy vaccinees is unknown at present and the need for booster doses is not yet defined (see CLINICAL PHARMACOLOGY).
A booster dose or revaccination with RECOMBIVAX HB Dialysis Formulation (blue color code) may be considered in predialysis/dialysis patients if the anti-HBs level is less than 10 MIU/mL 1 to 2 months after the third dose. The ACIP recommends that the need for booster doses of vaccine should be assessed by annual antibody testing and a booster dose given when antibody levels decline to <10 mIU/mL. Known or Presumed Exposure to HBsAg
There are no prospective studies directly testing the efficacy of a combination of HBIG and RECOMBIVAX HB in preventing clinical hepatitis B following percutaneous, ocular or mucous membrane exposure to hepatitis B virus. However, since most persons with such exposures (e.g., health-care workers) are candidates for RECOMBIVAX HB and since combined HBIG plus vaccine is more efficacious than HBIG alone in perinatal exposures, the following guidelines are recommended for persons who have been exposed to hepatitis B virus such as through (1) percutaneous (needlestick), ocular, mucous membrane exposure to blood known or presumed to contain HBsAg, (2) human bites by known or presumed HBsAg carriers, that penetrate the skin, or (3) following intimate sexual contact with known or presumed HBsAg carriers.
HBIG (0.06 mL/kg) should be given intramuscularly as soon as possible after exposure and within 24 hours if possible. RECOMBIVAX HB (see dosage recommendation) should be given intramuscularly at a separate site within 7 days of exposure and second and third doses given one and six months, respectively, after the first dose.
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