Vaccine Information: RECOMBIVAX HB
RECOMBIVAX HB- hepatitis b virus subtype adw hbsag surface protein antigen injection, suspension
Merck Sharp & Dohme LLC
1 INDICATIONS AND USAGE
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.
2 DOSAGE AND ADMINISTRATION
For intramuscular administration. See Section 2.2 for subcutaneous administration in persons with hemophilia.
RECOMBIVAX HB should be administered as soon as possible after being removed from refrigeration [see How Supplied/Storage and Handling (16)].
2.1 Dosage and Schedule
RECOMBIVAX HB:
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.
| Group | Dose/Regimen |
|---|---|
| |
| Infants *, Children and Adolescents0-19 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 |
2.2 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. Discard vial after use.
For single-dose prefilled syringes, securely attach a needle by twisting in a clockwise direction and administer dose of RECOMBIVAX HB intramuscularly. Discard syringe after use.
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.
2.3 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.
2.4 Booster Vaccinations
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}
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 (11) and How Supplied/Storage and Handling (16)]
4 CONTRAINDICATIONS
Do not administer RECOMBIVAX HB to individuals with a history of severe allergic or hypersensitivity reactions (e.g. , anaphylaxis) after a previous dose of any hepatitis B-containing vaccine or to any component of RECOMBIVAX HB, including yeast [see Description (11)].
5 WARNINGS AND PRECAUTIONS
5.1 Hypersensitivity to Latex
The vial stopper and the syringe plunger stopper and tip cap contain dry natural latex rubber, which may cause allergic reactions in latex-sensitive individuals.
5.2 Apnea in Premature Infants
Apnea following intramuscular vaccination has been observed in some infants born prematurely. Decisions about when to administer an intramuscular vaccine, including RECOMBIVAX HB, to infants born prematurely should be based on consideration of the individual infant’s medical status and the potential benefits and possible risks of vaccination. For RECOMBIVAX HB, this assessment should include consideration of the mother’s hepatitis B antigen status and the high probability of maternal transmission of hepatitis B virus to infants born to mothers who are HBsAg positive if vaccination is delayed.
5.3 Infants Weighing Less Than 2000 g
Hepatitis B vaccination should be delayed until 1 month of age or hospital discharge in infants weighing <2000 g if the mother is documented to be HBsAg negative at the time of the infant’s birth. Infants weighing <2000 g born to HBsAg positive or HBsAg unknown mothers should receive vaccine and hepatitis B immune globulin (HBIG) in accordance with ACIP recommendations if HBsAg status cannot be determined{3} [see Dosage and Administration (2)].
5.4 Prevention and Management of Allergic Vaccine Reactions
Appropriate medical treatment and supervision must be available to manage possible anaphylactic reactions following administration [see Contraindications (4)].
5.5 Limitations of Vaccine Effectiveness
Hepatitis B virus has a long incubation period. RECOMBIVAX HB may not prevent hepatitis B infection in individuals who have an unrecognized hepatitis B infection at the time of vaccination. Additionally, vaccination with RECOMBIVAX HB may not protect all individuals.
6 ADVERSE REACTIONS
In healthy infants and children (up to 10 years of age), the most frequently reported systemic adverse reactions (>1% injections), in decreasing order of frequency, were irritability, fever, diarrhea, fatigue/weakness, diminished appetite, and rhinitis. In healthy adults, injection site reactions and systemic adverse reactions were reported following 17% and 15% of the injections, respectively.
6.1 Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a vaccine cannot be directly compared to rates in the clinical trials of another vaccine and may not reflect the rates observed in practice.
In three clinical studies, 434 doses of RECOMBIVAX HB, 5 mcg, were administered to 147 healthy infants and children (up to 10 years of age) who were monitored for 5 days after each dose. Injection site reactions and systemic adverse reactions were reported following 0.2% and 10.4% of the injections, respectively. The most frequently reported systemic adverse reactions (>1% injections), in decreasing order of frequency, were irritability, fever (≥101°F oral equivalent), diarrhea, fatigue/weakness, diminished appetite, and rhinitis.
In a study that compared the three-dose regimen (5 mcg) with the two-dose regimen (10 mcg) of RECOMBIVAX HB in adolescents, the overall frequency of adverse reactions was generally similar.
In a group of studies, 3258 doses of RECOMBIVAX HB, 10 mcg, were administered to 1252 healthy adults who were monitored for 5 days after each dose. Injection site reactions and systemic adverse reactions were reported following 17% and 15% of the injections, respectively. The following adverse reactions were reported:
Incidence Equal To or Greater Than 1% of Injections
GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS
Injection site reactions consisting principally of soreness, and including pain, tenderness, pruritus, erythema, ecchymosis, swelling, warmth, nodule formation.
The most frequent systemic complaints include fatigue/weakness; headache; fever (≥100°F); malaise.
GASTROINTESTINAL DISORDERS
Nausea; diarrhea
RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS
Pharyngitis; upper respiratory infection
Incidence Less Than 1% of Injections
GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS
Sweating; achiness; sensation of warmth; lightheadedness; chills; flushing
GASTROINTESTINAL DISORDERS
Vomiting; abdominal pains/cramps; dyspepsia; diminished appetite
RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS
Rhinitis; influenza; cough
NERVOUS SYSTEM DISORDERS
Vertigo/dizziness; paresthesia
SKIN AND SUBCUTANEOUS TISSUE DISORDERS
Pruritus; rash (non-specified); angioedema; urticaria
MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS
Arthralgia including monoarticular; myalgia; back pain; neck pain; shoulder pain; neck stiffness
BLOOD AND LYMPHATIC DISORDERS
Lymphadenopathy
PSYCHIATRIC DISORDERS
Insomnia/disturbed sleep
EAR AND LABYRINTH DISORDERS
Earache
RENAL AND URINARY DISORDERS
Dysuria
CARDIAC DISORDERS
Hypotension
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