RECOMBIVAX HB® [Hepatitis B Vaccine, Recombinant] is indicated for prevention of infection caused by all known subtypes of hepatitis B virus. RECOMBIVAX HB is approved for use in individuals of all ages. RECOMBIVAX HB Dialysis Formulation is approved for use in adult predialysis and dialysis patients 18 years of age and older.
DOSAGE AND ADMINISTRATION
For intramuscular administration. See Section on Preparation and Administration for subcutaneous administration in persons with hemophilia.
Dosage And Schedule
Persons from birth through 19 years of age: A series of 3 doses (0.5 mL each) given on a 0-, 1-, and 6-month schedule.
Adolescents 11 through 15 years of age: A series of 3 doses (0.5 mL each) given on a 0-, 1-, and 6- month schedule or a series of 2 doses (1.0 mL each) on a 0- and 4- to 6-month schedule.
Persons 20 years of age and older: A series of 3 doses (1.0 mL each) given on a 0-, 1-, and 6-month schedule.
RECOMBIVAX HB Dialysis Formulation
Adults on predialysis and dialysis: A series of 3 doses (1.0 mL each) given on a 0-, 1-, and 6-month schedule.
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: RECOMBIVAX HB Recommended Dose and
|Infants*, Children and Adolescents 0-19 years of age (Pediatric/Adolescent Formulation)||5 mcg (0.5 mL) 3 doses at 0, 1, and 6 months|
|Adolescents† 11 through 15 years of age (Adult formulation)||10 mcg* (1.0 mL) 2 doses at 0 and 4-6 months|
|Adults ≥ 20 years of age (Adult formulation)||10 mcg* (1.0 mL) 3 doses at 0, 1, and 6 months|
|Predialysis and Dialysis Patients§ (Dialysis formulation)||40 mcg (1.0 mL) 3 doses at 0, 1, and 6 months|
|* For specific recommendations for infants see ACIP
† Adolescents (11 through 15 years of age) may receive either regimen: 3 x 5 mcg (Pediatric Formulation) or 2 x 10 mcg (Adult Formulation).
‡ If the suggested dose (10 mcg) is not available, the appropriate dosage can be achieved with two 5 mcg doses. However, the Dialysis Formulation may be used only for adult predialysis/dialysis patients.
§ See also recommendations for revaccination of predialysis and dialysis patients in [see Booster Vaccinations].
Preparation And Administration
Shake the single-dose vial or single-dose prefilled syringe well to obtain a slightly opaque, white suspension before withdrawal and use. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Discard if the suspension does not appear homogeneous or if extraneous particulate matter remains or if discoloration is observed.
For single-dose vials, withdraw and administer entire dose of RECOMBIVAX HB intramuscularly using a sterile needle and syringe.
For single-dose prefilled syringes, securely attach a needle by twisting in a clockwise direction and administer dose of RECOMBIVAX HB intramuscularly.
The deltoid muscle is the preferred site for intramuscular injection for adults, adolescents and children 1 year of age and older whose deltoid is large enough for intramuscular injection. The anterolateral aspect of the thigh is the preferred site for intramuscular injection for infants younger than 1 year of age. RECOMBIVAX HB should not be administered in the gluteal region, as injections given in the buttocks have resulted in lower seroconversion rates than expected.2 RECOMBIVAX HB may be administered subcutaneously to persons at risk for hemorrhage following intramuscular injections (e.g., hemophiliacs). However, hepatitis B vaccines are known to result in lower antibody response when administered subcutaneously.3 Additionally, when other aluminum-adsorbed vaccines have been administered subcutaneously, an increased incidence of local reactions including subcutaneous nodules has been observed. Therefore, consider subcutaneous administration only in persons who are at risk of hemorrhage following intramuscular injections.
Do not administer intravenously or intradermally
Known Or Presumed Exposure To Hepatitis B Virus
Known or Presumed Exposure to HBsAg
Refer to recommendations of the Advisory Committee on Immunization Practices (ACIP) and to the package insert for hepatitis B immune globulin (HBIG) for management of persons with known or presumed exposure to the hepatitis B virus (e.g., neonates born of infected mothers or persons who experienced percutaneous or permucosal exposure to the virus). When recommended, administer RECOMBIVAX HB and HBIG intramuscularly at separate sites (e.g., opposite anterolateral thighs for exposed neonates) as soon as possible after exposure. Administer additional doses of RECOMBIVAX HB (to complete a vaccination series) in accordance with ACIP recommendations.
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. The ACIP provides recommendations for use of a booster dose or revaccination series in previously vaccinated individuals with known or presumed exposure to Hepatitis B Virus.
Consider a booster dose or revaccination with RECOMBIVAX HB Dialysis Formulation (blue color code) in predialysis/dialysis patients if the anti-HBs level is less than 10 mIU/mL at 1 to 2 months after the third dose. Assess the need for a booster dose annually by antibody testing, and give a booster dose when the anti-HBs level declines to less than 10 mIU/mL.3
Dosage Forms And Strengths
RECOMBIVAX HB is a sterile suspension available in the following presentations:
- 0.5 mL (5 mcg) Pediatric/Adolescent Formulation single-dose vials and prefilled syringes
- 1 mL (10 mcg) Adult Formulation single-dose vials and prefilled syringes
RECOMBIVAX HB DIALYSIS FORMULATION is a sterile suspension available in the following presentation:
- 1 mL (40 mcg) single-dose vial [see DESCRIPTION and Storage and Handling]
Storage And Handling
RECOMBIVAX HB and RECOMBIVAX HB DIALYSIS FORMULATION are available in single-dose vials and prefilled Luer-Lok® syringes.
Pediatric/Adolescent Formulation (PRESERVATIVE FREE)
0.5 mL (5 mcg) in single-dose vials and prefilled Luer-Lok® syringes
NDC 0006-4981-00 – box of ten 0.5-mL single-dose vials
Color coded with a yellow cap and stripe on the vial labels and cartons and an orange banner on the vial labels and cartons
NDC 0006-4093-02 – carton of 10 prefilled single-dose Luer-Lok® syringes with tip caps
Color coded with a yellow plunger rod
NDC 0006-4093-09 – carton of six 0.5-mL prefilled single-dose Luer-Lok® syringes with tip caps
Color coded with a yellow plunger rod and stripe
Adult Formulation (PRESERVATIVE FREE)
1 mL (10mcg) in single-dose vials and prefilled Luer-Lok® syringes
NDC 0006-4995-00 – 1-mL single dose vial
Color coded with a green cap and stripe
NDC 0006-4995-41 – box of ten 1-mL single-dose vials
Color coded with a green cap and stripe
NDC 0006-4094-02 – carton of 10 pre-filled single-dose syringes with tip caps
Color coded with a green plunger rod
NDC 0006-4094-09 – carton of six 1-mL prefilled single-dose Luer-Lok® syringes with tip caps
Color coded with a green plunger rod and stripe
RECOMBIVAX HB DIALYSIS FORMULATION
1 mL (40mcg) in single-dose vials
NDC 0006-4992-00 – 1-mL single-dose vial
Color coded with a blue cap and stripe
Store vials and syringes at 2-8°C (36-46°F). Storage above or below the recommended temperature may reduce potency.
Do not freeze since freezing destroys potency.
1. CDC. A Comprehensive Strategy to Eliminate Transmission of Hepatitis B Virus Infection in the United States. Recommendations of the Advisory Committee on Immunization Practices (ACIP) Part I: Immunization of Infants, Children and Adolescents. MMWR Recommendations and Reports 2005; 54(RR16): 1-23. Appendix C - Postexposure Prophylaxis of Persons with Discrete Identifiable Exposures to Hepatitis B Virus (HBV) and http://www.cdc.gov/hepatitis/hbv/pdfs/correctedtable4.pdf
2. CDC. Suboptimal Response to Hepatitis B Vaccine given by Injection into the Buttock. MMWR Weekly Report 1985; 34: 105-8, 113.
3. Centers for Disease Control and Prevention. A Comprehensive Immunization Strategy to Eliminate Transmission of Hepatitis B Virus Infection in the United States. Recommendations of the Advisory Committee on Immunization Practices (ACIP). Part 2: Immunization of Adults, MMWR 2006, 55(RR-16): 1-25.
Manuf. and Dist. by: Merck Sharpe & Dohme Corp., a subsidiary of MERCK & CO., INC., Whitehouse Station, NJ 08889, USA. Revised: 05/2014This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 9/2/2014
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