Version May 2024
Note: According to Advisory Committee on Immunization Practices, doses administered ≤4 days before minimum interval or age are considered valid; however, local or state mandates may supersede this timeframe (Ref).
Primary immunization: Note: Adult formulations of hepatitis B vaccine products differ by concentration (mcg/mL) but when dosed in terms of volume (mL), the dose of Engerix-B and Recombivax HB are the same. Recombivax HB adult formulation contains 10 mcg/mL and Recombivax HB dialysis formulation contains 40 mcg/mL; See "Dosing: Altered Kidney Function" for dosing in adult patients with chronic kidney disease and/or dialysis.
Immunocompetent adults (nondialysis):
18 to <20 years of age: IM: 0.5 mL/dose (adult formulation) for 3 total doses administered at 0, 1, and 6 months.
≥20 years of age: IM: 1 mL/dose (adult formulation) for 3 total doses administered at 0, 1, and 6 months.
Note: Refer to CDC guidelines (Ref) for other schedule options. Manufacturer labeling may also include alternate immunization schedules.
Adults with immunocompromising conditions (off-label use): Note: Some experts consider use of high-dose (40 mcg) hepatitis B vaccine for patients with immunocompromising conditions (eg, HIV infection, cirrhosis, transplantation, receipt of chemotherapy) despite limited data (Ref).
Engerix-B 20 mcg/mL: IM: Administer 2 mL per dose at 0, 1, 2, and 6 months (4 doses).
Recombivax HB 40 mcg/mL: IM: Administer 1 mL per dose at 0, 1, and 6 months (3 doses).
Revaccination (Ref): IM: For certain persons who received a complete HBV vaccine series (eg, persons receiving hemodialysis, persons with HIV, persons who are immunocompromised, health care personnel, sex partners of hepatitis B surface antigen [HBsAg]-positive persons), anti-HBs testing is recommended 1 to 2 months after the final dose. If anti-HBs levels <10 milliunits/mL, revaccinate with either a second, complete vaccination series or with a single hepatitis B vaccine dose, followed by anti-HBs testing 1 to 2 months later. If only a single dose was given for revaccination and anti-HBs levels remain <10 milliunits/mL, complete the vaccine series; perform anti-HBs testing 1 to 2 months later.
Interchangeability (Ref): The Advisory Committee on Immunization Practices recommends completing the vaccine series with the same product whenever possible. If continuing with same product will cause vaccination to be deferred, or if product used previously is unknown or unavailable, vaccination should be completed with the product available. A 2-dose HepB vaccine series is only appropriate when both doses in the series consist of HepB-CpG (Heplisav-B). If 1 dose of HepB-CpG and another dose from a different manufacturer were previously given, then a third vaccine dose should be given. For any 3-dose series, minimum intervals are as follows: 4 weeks between dose 1 and 2; 8 weeks between dose 2 and 3; 16 weeks between dose 1 and 3.
Bombings or similar mass-casualty events: IM: In persons without a reliable history of vaccination against HepB and who have no known contraindications to the vaccine, vaccination should begin within 24 hours (but no later than 7 days) following the event (Ref).
Postexposure management:
Health care personnel (HCP) (Ref): IM:
Documented vaccine responder: If the HCP has prior documentation of ≥3 doses of a hepatitis B vaccine and a postvaccination anti-HBs ≥10 milliunits/mL, then additional hepatitis B vaccine is not needed, regardless of the patient's HBsAg status. HCP is considered seroprotected.
Unvaccinated or incompletely vaccinated: Test source patient for HBsAg as soon as possible after exposure. Administer a complete hepatitis B vaccine series to the HCP; if source patient positive or unknown status for HBsAg, begin vaccination series as soon as possible (with a dose of HBIG). Follow up with anti-HBs testing 1 to 2 months after the final vaccine dose. If anti-HBs levels are <10 milliunits/mL, then the HCP should receive a second, complete vaccine series followed by anti-HBs testing 1 to 2 months after the final vaccine dose.
Vaccinated with 3 doses of hepatitis B vaccine but postvaccination anti-HBs status is unknown: Test HCP for anti-HBs.
If anti-HBs ≥10 milliunits/mL, no additional hepatitis B vaccine is needed.
If anti-HBs <10 milliunits/mL and the source patient status is HBsAg positive or unknown, revaccinate the HCP with a complete 3-dose vaccination series and administer 1 dose of HBIG as soon as possible. Anti-HBs testing should be performed 1 to 2 months after the final vaccine dose.
If anti-HBs <10 milliunits/mL and the source patient is HBsAg negative, the HCP should receive a single vaccine dose followed by anti-HBs testing 1 to 2 months later. If anti-HBs levels remain <10 milliunits/mL, then 2 additional vaccine doses should be administered and anti-HBs testing performed 1 to 2 months after the final vaccine dose.
Vaccinated with 6 doses of hepatitis B vaccine (2 complete series) but documented as a nonresponder to the vaccine: No postexposure vaccination is recommended. If the source patient status is HBsAg positive or unknown, administer 2 doses of HBIG separated by 1 month.
Nonoccupational settings (Ref): IM:
Documented vaccine recipient without post-vaccination anti-HBs testing: If exposure was to an HBsAg-positive source, administer a single dose of hepatitis B vaccine. If exposure was to an HBsAg-unknown source, then no additional treatment required.
Vaccination in process: Complete the vaccination series. If exposure was to an HBsAg-positive source, also administer a dose of HBIG.
Unvaccinated: If exposure was to an HBsAg-positive source, administer both hepatitis B vaccine and HBIG as soon as possible (preferably within 24 hours after exposure [<7 days for percutaneous exposure or <14 days for sexual exposure]); complete the vaccination series. If exposure was to an HBsAg-unknown source, administer complete vaccination series.
Patients ≥20 years of age:
Chronic kidney disease (predialysis): Recombivax HB 40 mcg/mL: IM: Administer 1 mL per dose at 0, 1, and 6 months.
Hemodialysis: IM:
Engerix-B 20 mcg/mL: Administer 2 mL per dose at 0, 1, 2, and 6 months
Recombivax HB 40 mcg/mL: Administer 1 mL per dose at 0, 1, and 6 months
Note: Serologic testing is recommended for patients receiving hemodialysis 1 to 2 months after the final dose of the primary vaccine series and annually to determine the need for booster doses. Persons with anti-HBs concentrations of <10 milliunits/mL should receive a booster dose (Ref).
There are no dosage adjustments provided in the manufacturer's labeling.
Refer to adult dosing.
(For additional information see "Conventional recombinant hepatitis B vaccines (HepB) (Engerix-B; Recombivax HB): Pediatric drug information")
Note: Although hepatitis B vaccine products differ by concentration (mcg/mL), when dosed in terms of volume (mL), the equivalent dose is the same between products (ie, 0.5 mL of Recombivax-HB is equivalent to 0.5 mL of Engerix-B). Combination vaccines may be used to complete the immunization series after the infant is 6 weeks of age. Please see combination vaccine monographs for dose and schedule details. Vaccines from different manufacturers are interchangeable during an immunization series with the exception of an adolescent (11 to 15 years) 2-dose Recombivax-HB regimen (Ref).
According to ACIP, doses administered ≤4 days before minimum interval or age are considered valid; however, local or state mandates may supersede this timeframe (ACIP [Kroger 2023]).
Primary immunization:
CDC (ACIP) recommendations (Ref): Infants: Recombivax-HB, Engerix-B (Pediatric/Adolescent formulation): IM: 0.5 mL per dose for a total of 3 doses given as follows: Ideally first dose is administered at birth, the second dose at 1 to 2 months of age, and a final third dose at 6 months up to 18 months of age; minimum age for the final (third) dose is 24 weeks.
Infants born to HBsAg-negative mothers:
First dose: 0.5 mL within 24 hours of birth.
Second dose: 0.5 mL at 1 to 2 months of age.
Third dose: 0.5 mL at 6 to 18 months of age. The final dose should be given ≥8 weeks after the second dose and ≥16 weeks after the first dose, but no sooner than 24 weeks of age. For populations with current or historically elevated rates of childhood HBV infection, the final dose should be administered between 6 and 12 months of age.
Note: In neonates weighing <2 kg at birth, administer the initial dose at 30 days of chronological age or at hospital discharge (whichever is first).
Infants born to HBsAg- positive mothers:
Neonates weighing ≥2 kg at birth and infants should receive the usual 3-dose series; neonates weighing <2 kg at birth should receive a 4-dose series due to potential decreased immunogenicity.
First dose: 0.5 mL within first 12 hours of life, regardless of birth weight; HBIG should also be administered at the same time at a different anatomical site.
Second dose: 0.5 mL, timing of dose dependent on birthweight:
Birthweight <2 kg: At 1 month of age.
Birthweight ≥2 kg: At 1 to 2 months of age.
Third dose: 0.5 mL, timing of dose dependent on birthweight:
Birthweight <2 kg: At 2 to 3 months of age.
Birthweight ≥2 kg: Final dose: At 6 months of age. This dose should be given ≥8 weeks after the second dose and ≥16 weeks after the first dose, but no sooner than 24 weeks of age.
Fourth dose: Birthweight <2 kg: Final dose: At least 6 months of age (24 weeks).
Follow-up serologic testing after completion of vaccine series: Anti-HBs and HBsAg levels should be checked at 9 to 12 months of age (ie, next well-child visit after series completion). If level ≥10 milliunits/mL, no further action needed. If HBsAg negative and anti-HBs levels <10 milliunits/mL, revaccinate with a single vaccine dose and reassess 1 to 2 months later. If anti-HBs levels remain <10 milliunits/mL, administer 2 additional vaccine doses to complete the second vaccination series and reassess anti-HBs levels 1 to 2 months after the final dose. Alternatively, HBsAg-negative infants with anti-HBs levels <10 milliunits/mL may receive a second, complete 3-dose vaccination series followed by a reassessment of anti-HBs and HBsAg levels 1 to 2 months after the final dose.
Infants born to mothers whose HBsAg status is unknown at birth:
Birthweight <2 kg: Manage as if born to HBsAg-positive mother (ie, birth dose of vaccine not counted in series); once maternal status determined, follow applicable schedule.
Birthweight ≥2 kg: Manage as if born to HBsAg-positive mother; once maternal status determined, follow applicable schedule.
Canadian labeling: 0.5 mL/dose (pediatric/adolescent formulation) for 3 total doses administered at 0, 1, and 6 months. For accelerated protection, a 4-dose series can be administered at 0, 1, and 2 months plus a booster at 12 months.
Catch-up immunization: Note: Do not restart the series. If doses have been given, begin the below schedule at the applicable dose number.
Recombivax-HB, Engerix-B (Pediatric/Adolescent formulation): Infants ≥4 months, Children, and Adolescents: IM: 0.5 mL per dose for 3 total doses; refer to annual immunization and CDC guideline (Ref) for timing options.
Recombivax HB (Adult formulation): Adolescents 11 to 15 years: IM: 1 mL per dose for 2 doses; first dose given on the elected date, second dose given 4 to 6 months later if patient still ≤15 years. Note: Refer to most recent CDC guideline for other options. Manufacturer's labeling may include alternate immunization schedules.
Revaccination (Ref): Note: Booster doses are generally not recommended for persons with a normal immune status. When determined necessary by serologic testing, booster doses can be considered in immunocompromised persons with an ongoing risk for hepatitis B exposure. Hemodialysis patients may also need revaccination; refer to Dosing: Renal Impairment: Pediatric.
Children and Adolescents with annual anti-HBs level <10 milliunits/mL: Administer 1 additional hepatitis B dose; dose volume dependent upon patient age and product (see previous dosing for specific details).
Bombings or similar mass casualty events: IM: In persons without a reliable history of vaccination against hepatitis B and who have no known contraindications to the vaccine, vaccination should begin within 24 hours (but no later than 7 days) following the event (Ref).
Hemodialysis patients often respond poorly to hepatitis B vaccination; higher vaccine doses or increased number of doses may be required. The anti-HBs (antibody to hepatitis B surface antigen) response of such persons should be tested after they are vaccinated, and those who have not responded should be revaccinated with 1 to 3 additional doses. Patients with chronic renal disease should be vaccinated as early as possible, ideally before they require hemodialysis.
Chronic renal impairment: Infants, Children, and Adolescents: IM: Administer a 3-dose series with subsequent doses at 1 to 2 and 4 to 6 months after the initial dose; repeat dose depending upon annual assessment of anti-HBs level; if anti-HBs <10 milliunits/mL administer an additional dose (Ref)
Dialysis and predialysis patients (CrCl <60 mL/minute/1.73 m2): Infants, Children, and Adolescents: IM: There are no specific ACIP recommendations regarding dosing in dialysis patients; however, some experts suggest that pediatric patients follow standard pediatric schedule; higher doses or additional doses may be required (Ref)
Recombivax HB (40 mcg/mL dialysis formulation): Limited data available: Children and Adolescents: IM: 0.5 mL/dose (20 mcg) for 3-dose series with subsequent doses at 1 month and 6 months after the first dose. Dosing based on a multicenter trial of 78 pediatric patients (age: 1 to 18 years) using Recombivax-HB (Dialysis formulation) and showed protective levels of antibody occurring in 75% to 97% of pediatric hemodialysis patients using higher dose (Ref)
There are no dosage adjustments provided in the manufacturer's labeling.
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified. Adverse reactions reported in pediatric patients and adults.
>10%:
Local: Local soreness/soreness at injection site (22%)
Nervous system: Fatigue (14%)
1% to 10%:
Gastrointestinal: Decreased appetite, diarrhea, nausea
Local: Injection-site reaction (including ecchymoses, erythema at injection site, induration at injection site, injection-site nodule, injection-site pruritus, pain at injection site, swelling at injection site, tenderness at injection site, warm sensation at injection site)
Nervous system: Asthenia, dizziness, headache, irritability, malaise
Respiratory: Pharyngitis, rhinitis, upper respiratory tract infection
Miscellaneous: Fever
<1%:
Cardiovascular: Flushing, hypotension
Dermatologic: Diaphoresis, erythema of skin, pruritus, skin rash, urticaria
Gastrointestinal: Abdominal pain, anorexia, constipation, dyspepsia, stomach cramps, vomiting
Genitourinary: Dysuria
Hematologic & oncologic: Lymphadenopathy, petechia
Hypersensitivity: Angioedema
Infection: Influenza
Local: Localized warm feeling
Nervous system: Agitation, body pain, chills, drowsiness, insomnia, paresthesia, sleep disturbance, tingling sensation, vertigo
Neuromuscular & skeletal: Arm and/or wrist pain, arthralgia, back pain, myalgia, neck pain, neck stiffness, shoulder pain, shoulder stiffness, stiffness of arms
Respiratory: Cough, flu-like symptoms
Postmarketing:
Cardiovascular: Palpitations, polyarteritis nodosa, syncope, tachycardia, vasculitis
Dermatologic: Alopecia, eczema, erythema multiforme, erythema nodosum (Rogerson 1990), lichen planus, Stevens-Johnson syndrome
Hematologic & oncologic: Evan syndrome (Martínez 1992), immune thrombocytopenia (Ronchi 1998), increased erythrocyte sedimentation rate, purpuric disease, thrombocytopenia
Hepatic: Increased liver enzymes
Hypersensitivity: Hypersensitivity angiitis (Allen 1993), hypersensitivity reaction (including anaphylaxis, nonimmune anaphylaxis), serum sickness-like reaction (may be delayed days to weeks)
Infection: Herpes zoster infection
Nervous system: Encephalitis, encephalopathy, Guillain-Barré syndrome, hypoesthesia, meningitis, migraine, multiple sclerosis (including acute exacerbations of multiple sclerosis), myasthenia, nerve root disorder, neuritis, neuropathy, paralysis (including Bell palsy) (Paul 2014), paresis, peripheral neuropathy, seizure (including febrile seizure)
Neuromuscular & skeletal: Arthritis (including polyarthritis) (Rogerson 1990), limb pain, lupus-like syndrome, myelitis (including transverse myelitis), systemic lupus erythematosus (Tudela 1992)
Ophthalmic: Conjunctivitis, keratitis, optic neuritis, uveitis, visual disturbance
Otic: Tinnitus
Renal: Glomerulonephritis (Pennesi 2002), nephrotic syndrome (Ozdemir 1998)
Respiratory: Apnea, bronchospasm (including asthma-like symptoms)
Severe allergic or hypersensitivity reaction to yeast, hepatitis B vaccine, or any component of the formulation.
Canadian labeling: Additional contraindications (not in US labeling): Known hypersensitivity to any component of the formulation; severe febrile illness.
Concerns related to adverse effects:
• Anaphylactoid/hypersensitivity reactions: Immediate treatment (including epinephrine 1 mg/mL) for anaphylactoid and/or hypersensitivity reactions should be available during vaccine use (ACIP [Kroger 2023]).
• Shoulder injury related to vaccine administration: Vaccine administration that is too high on the upper arm may cause shoulder injury (eg, shoulder bursitis or tendinopathy) resulting in shoulder pain and reduced range of motion following injection. Use proper injection technique for vaccines administered in the deltoid muscle (eg, injecting in the central, thickest part of the muscle) to reduce the risk of shoulder injury related to vaccine administration (Cross 2016; Foster 2013).
• Syncope: Syncope has been reported with use of injectable vaccines and may result in serious secondary injury (eg, skull fracture, cerebral hemorrhage); typically reported in adolescents and young adults and within 15 minutes after vaccination. Procedures should be in place to avoid injuries from falling and to restore cerebral perfusion if syncope occurs (ACIP [Kroger 2023]).
Disease-related concerns:
• Acute illness: The decision to administer or delay vaccination because of current or recent febrile illness depends on the severity of symptoms and the etiology of the disease. Postpone administration in patients with moderate or severe acute illness (with or without fever); vaccination should not be delayed for patients with mild acute illness (with or without fever) (ACIP [Kroger 2023]). Canadian labeling contraindicates use of the vaccine in patients with severe febrile illness.
• Bleeding disorders: Use with caution in patients with bleeding disorders (including thrombocytopenia); bleeding/hematoma may occur from IM administration; if the patient receives antihemophilia or other similar therapy, IM injection can be scheduled shortly after such therapy is administered (ACIP [Kroger 2023]).
• Multiple sclerosis: Postmarketing reports of multiple sclerosis (MS) exacerbations have been reported; however, clinical studies indicate no association between vaccination and MS.
Special populations:
• Altered immunocompetence: Postpone vaccination during periods of severe immunosuppression (eg, patients receiving chemo/radiation therapy or other immunosuppressive therapy [including high-dose corticosteroids]) if appropriate; may have a reduced response to vaccination. In general, household and close contacts of persons with altered immunocompetence may receive all age-appropriate vaccines. Nonlive vaccines should be administered ≥2 weeks prior to planned immunosuppression when feasible; nonlive vaccines administered during chemotherapy should be readministered after immune competence is regained (ACIP [Kroger 2023]; IDSA [Rubin 2014]).
• Older adults: Patients >60 years of age may have lower response rates (CDC/ACIP [Schillie 2018a]).
• Pediatric: In general, preterm infants should be vaccinated at the same chronological age as full-term infants (ACIP [Kroger 2023]); however, infants born to HBsAg-negative mothers and weighing <2 kg at birth should have the initial dose deferred up to 30 days of chronological age or until hospital discharge. If the mother's HBsAg status at delivery is unknown or positive, hepatitis B vaccine and hepatitis B immune globulin should be administered within 12 hours of birth and the first dose of the vaccine should not be counted as part of the vaccine series (CDC/ACIP [Schillie 2018a]). Apnea has been reported following IM vaccine administration in premature infants; consider clinical status implications (AAP [Saari 2003]; ACIP [Kroger 2023]).
Concurrent drug therapy issues:
• Anticoagulant therapy: Use with caution in patients receiving anticoagulant therapy; bleeding/hematoma may occur from IM administration (ACIP [Kroger 2023]).
• Vaccines: In order to maximize vaccination rates, the ACIP recommends simultaneous administration (ie, >1 vaccine on the same day at different anatomic sites) of all age-appropriate vaccines (live or nonlive) for which a person is eligible at a single visit, unless contraindications exist. The ACIP prefers each dose of a specific vaccine in a series come from the same manufacturer when possible; however, vaccination should not be deferred because a specific brand name is unavailable (ACIP [Kroger 2023]).
Dosage form specific issues:
• Latex: Recombivax HB: Packaging may contain natural latex rubber.
Other warnings/precautions:
• Antipyretics: Antipyretics have not been shown to prevent febrile seizures; antipyretics may be used to treat fever or discomfort following vaccination (ACIP [Kroger 2023]). One study reported that routine prophylactic administration of acetaminophen to prevent fever prior to vaccination decreased the immune response of some vaccines; the clinical significance of this reduction in immune response has not been established (Prymula 2009).
• Appropriate use: Use of this vaccine for specific medical and/or other indications (eg, immunocompromising conditions, hepatic or kidney disease, diabetes) is also addressed in the annual ACIP Recommended Immunization Schedules (refer to CDC schedule for detailed information). Specific recommendations for vaccination in immunocompromised patients with asplenia, cancer, HIV infection, cerebrospinal fluid leaks, cochlear implants, hematopoietic stem cell transplant (prior to or after), sickle cell disease, solid organ transplant (prior to or after), or those receiving immunosuppressive therapy for chronic conditions are available in the IDSA guidelines (Rubin 2014).
• Effective immunity: Vaccination may not result in effective immunity in all patients. Response depends upon multiple factors (eg, type of vaccine, age of patient) and is improved by administering the vaccine at the recommended dose, route, and interval (ACIP [Kroger 2023]). Due to the long incubation period for hepatitis, unrecognized hepatitis B infection may be present prior to vaccination; immunization may not prevent infection in these patients.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Injection, suspension [adult, preservative free]:
Engerix-B: Hepatitis B surface antigen 20 mcg/mL (1 mL) [contains aluminum, yeast protein, may contain natural rubber/natural latex in prefilled syringe]
Engerix-B: Hepatitis B surface antigen 20 mcg/mL (1 mL) [contains aluminum, yeast protein; vial]
Recombivax HB: Hepatitis B surface antigen 10 mcg/mL (1 mL) [contains aluminum, formaldehyde, natural rubber/natural latex in packaging, yeast protein]
Injection, suspension [dialysis formulation, preservative free]:
Recombivax HB: Hepatitis B surface antigen 40 mcg/mL (1 mL) [contains aluminum, natural rubber/natural latex in packaging, yeast protein]
Injection, suspension [pediatric/adolescent, preservative free]:
Engerix-B: Hepatitis B surface antigen 10 mcg/0.5 mL (0.5 mL) [contains aluminum, yeast protein, may contain natural rubber/natural latex in prefilled syringe]
Recombivax HB: Hepatitis B surface antigen 5 mcg/0.5 mL (0.5 mL) [contains aluminum, natural rubber/natural latex in packaging, yeast protein]
No
Suspension (Engerix-B Injection)
20 mcg/mL (per mL): $83.24
Suspension (Recombivax HB Injection)
5 mcg/0.5 mL (per 0.5 mL): $32.39
10 mcg/mL (per mL): $80.04
40 mcg/mL (per mL): $217.49
Suspension Prefilled Syringe (Engerix-B Injection)
10 mcg/0.5 mL (per 0.5 mL): $33.96
20 mcg/mL (per mL): $83.24
Suspension Prefilled Syringe (Recombivax HB Injection)
5 mcg/0.5 mL (per 0.5 mL): $32.39
10 mcg/mL (per mL): $80.04
Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.
IM: For IM administration. Adult formulations of hepatitis B vaccine products differ by concentration (mcg/mL), but when dosed in terms of volume (mL), the dose of Engerix-B and Recombivax HB are the same.
IM injection (preferred); do not administer IV or intradermally; the deltoid muscle is the preferred site. Use proper injection technique in the deltoid muscle (eg, injecting in the central, thickest part of the muscle) to reduce the risk of shoulder injury related to vaccine administration (Ref). Not for gluteal administration. Shake well prior to withdrawal and use. Do not mix with other vaccines or injections; separate needles and syringes should be used for each injection. May be administered at the same time as HBIG but at a different anatomical site. To prevent syncope-related injuries, patients should be vaccinated while seated or lying down (Ref). US law requires that the date of administration, the vaccine manufacturer, lot number of vaccine, Vaccine Information Statement (VIS) edition date and date it was provided, and the administering person's name, title, and address be recorded.
For patients at risk of hemorrhage following intramuscular injection, hepatitis B vaccine may be administered subcutaneously although lower titers and/or increased incidence of local reactions may result. The ACIP recommends that the vaccine should be administered intramuscularly if, in the opinion of the physician familiar with the patient's bleeding risk, the vaccine can be administered by this route with reasonable safety. If the patient receives antihemophilia or other similar therapy, intramuscular vaccination can be scheduled shortly after such therapy is administered. A fine needle (23-gauge or smaller) can be used for the vaccination and firm pressure applied to the site (without rubbing) for at least 2 minutes. The patient should be instructed concerning the risk of hematoma from the injection. Patients on anticoagulant therapy should be considered to have the same bleeding risks and treated as those with clotting factor disorders (Ref).
Vaccination at the time of serologic testing: For persons in whom vaccination and serologic testing is recommended, the first dose of hepatitis B vaccine can be given after blood is drawn to test for HBsAg, antibody to HBsAg, and antibody to hepatitis B core antigen (Ref).
For IM administration: Pediatric/adolescent formulations of hepatitis B vaccine products differ by concentration (mcg/mL). However, when dosed in terms of volume (mL), the dose of Engerix-B and Recombivax HB are the same (both 0.5 mL). Adult formulations of hepatitis B vaccine products also differ by concentration (mcg/mL), but when dosed in terms of volume (mL), the dose of Engerix-B and Recombivax HB are the same (both 1 mL).
Shake well; administer IM into midlateral aspect of the thigh in infants and small children; administer in the deltoid area to older children and adults; not for gluteal administration. If injecting in the deltoid muscle, use proper injection technique (eg, injecting in the central, thickest part of the muscle) to reduce the risk of shoulder injury related to vaccine administration (Ref). Not for IV or intradermal administration. Do not mix with other vaccines or injections; separate needles and syringes should be used for each injection. May be administered at the same time as HBIG but at a different anatomical site (Ref). To prevent syncope-related injuries, adolescents should be vaccinated while seated or lying down (Ref). US law requires that the date of administration, the vaccine manufacturer, lot number of vaccine, Vaccine Information Statement (VIS) edition date and date it was provided, and the administering person's name, title, and address be recorded.
For patients at risk of hemorrhage following intramuscular injection, hepatitis B vaccine may be administered subcutaneously although lower titers and/or increased incidence of local reactions may result. The ACIP recommends that the vaccine should be administered intramuscularly if, in the opinion of the physician familiar with the patient's bleeding risk, the vaccine can be administered by this route with reasonable safety. If the patient receives antihemophilia or other similar therapy, intramuscular vaccination can be scheduled shortly after such therapy is administered. A fine needle (23-gauge or smaller) can be used for the vaccination and firm pressure applied to the site (without rubbing) for at least 2 minutes. The patient should be instructed concerning the risk of hematoma from the injection. Patients on anticoagulant therapy should be considered to have the same bleeding risks and treated as those with clotting factor disorders (Ref).
Vaccination at the time of serologic testing: For persons in whom vaccination and serologic testing is recommended, the first dose of hepatitis B vaccine can be given after blood is drawn to test for HBsAg, antibody to HBsAg, and antibody to hepatitis B core antigen (Ref).
In the US, the appropriate Centers for Disease Control and Prevention (CDC)-approved Vaccine Information Statement (VIS) must be provided to the patient/caregiver before administering each dose of this vaccine; the VIS edition date and date it was provided to the patient/caregiver should be recorded as required by US law; VIS is available at http://www.cdc.gov/vaccines/hcp/vis/vis-statements/hep-b.html.
Hepatitis B disease prevention: Active immunization against infection caused by all known subtypes of hepatitis B virus (HBV).
The Advisory Committee on Immunization Practices (ACIP) recommends routine vaccination for the following (CDC/ACIP [Schillie 2018a]; CDC/ACIP [Weng 2022]):
- All neonates (regardless of weight) born to either hepatitis B surface antigen (HBsAg) positive mother or mother with unknown status (administer first dose within 12 hours of birth).
- All neonates weighing ≥2 kg (eg, term) born to HBsAg negative mother (administer first dose within 24 hours of birth).
- All neonates weighing <2 kg (eg, preterm) born to HBsAg negative mother (administer first dose at 1 month of age or prior to hospital discharge).
- All unvaccinated infants, children, and adolescents <19 years of age.
- All unvaccinated adults 19 to 59 years of age; adults ≥60 years of age without known risk factors may also receive vaccination.
- All unvaccinated adults ≥60 years of age at risk for HBV infection such as those with:
Sexual exposure risk: Sex partners of persons who are HBsAg-positive; sexually active persons not in a long-term, mutually monogamous relationship; persons seeking evaluation for a sexually transmitted infection; men who have sex with men.
Exposure to blood: Persons with current or recent injection drug use; household contacts of persons who are HBsAg-positive; residents and staff of facilities for persons with developmental disabilities; health care personnel and public safety workers with reasonably anticipated risk for exposure to blood or blood contaminated body fluids.
Medical risks: Persons receiving maintenance dialysis (including hemodialysis and peritoneal dialysis) or who are predialysis; persons with HIV or hepatitis C virus infection; persons with chronic liver disease (eg, cirrhosis, fatty liver disease, alcoholic liver disease, autoimmune hepatitis, ALT or AST level >2 times the ULN); persons with diabetes mellitus (per clinical discretion).
Other risks: International travelers to regions with high or intermediate levels of endemic HBV infection; incarcerated persons.
In addition, the ACIP recommends vaccination for any persons who are wounded in bombings or similar mass casualty events who have penetrating injuries or non-intact skin exposure, or who have contact with mucous membranes (exception - superficial contact with intact skin), and who cannot confirm receipt of a hepatitis B vaccination (CDC [Chapman 2008]).
Engerix-B adult may be confused with Engerix-B pediatric/adolescent
Recombivax HB may be confused with Comvax
Recombivax HB may be confused with Recombivax HB Dialysis Formulation
HepB (hepatitis B vaccine) may be confused with HepA (hepatitis A vaccine)
HepB (hepatitis B vaccine) may be confused with Hib (Haemophilus b conjugate vaccine)
HepB (hepatitis B vaccine) may be confused with HPV4 (human papillomavirus vaccine [quadrivalent]; 4vHPV is the correct abbreviation)
HBV (previously used for hepatitis B vaccine; HepB is correct abbreviation) may be confused with HPV (human papilloma virus vaccine; 2vHPV, 4vHPV, or 9vHPV are the correct abbreviations)
None known.
Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the Lexicomp drug interactions program by clicking on the “Launch drug interactions program” link above.
Acetaminophen: May diminish the therapeutic effect of Vaccines. Management: Consider avoiding routine prophylactic use of acetaminophen before or during vaccine administration when possible. Acetaminophen is still recommended to treat fevers and/or pain that occurs after vaccination. Risk D: Consider therapy modification
Anti-CD20 B-Cell Depleting Therapies: May diminish the therapeutic effect of Vaccines (Inactivated/Non-Replicating). Management: Give inactivated vaccines at least 2 weeks prior to initiation or 6 months after anti-CD20 B-cell depleting therapies. If vaccinated prior to B cell recovery, consider assessing immune response to vaccination. Risk D: Consider therapy modification
Cladribine: May diminish the therapeutic effect of Vaccines (Inactivated/Non-Replicating). Management: Give inactivated vaccines at least 2 weeks prior to initiation of cladribine when possible. Patients vaccinated less than 14 days before initiating or during cladribine should be revaccinated at least 3 months after therapy is complete. Risk D: Consider therapy modification
Corticosteroids (Systemic): May diminish the therapeutic effect of Vaccines (Inactivated/Non-Replicating). Management: Administer vaccines at least 2 weeks prior to immunosuppressive corticosteroids if possible. If patients are vaccinated less than 14 days prior to or during such therapy, repeat vaccination at least 3 months after therapy if immunocompetence restored. Risk D: Consider therapy modification
Elivaldogene Autotemcel: May enhance the adverse/toxic effect of Vaccines. Specifically, there may be a greater risk for contracting an infection from any live vaccine. Elivaldogene Autotemcel may diminish the therapeutic effect of Vaccines. Management: Administration of vaccines is not recommended in the 6 weeks before myeloablative conditioning, and until hematologic recovery after elivaldogene autotemcel treatment. Risk X: Avoid combination
Fingolimod: May diminish the therapeutic effect of Vaccines (Inactivated/Non-Replicating). Management: Vaccine efficacy may be reduced. Complete all age-appropriate vaccinations at least 2 weeks prior to starting fingolimod. If vaccinated during fingolimod therapy, revaccinate 2 to 3 months after fingolimod discontinuation. Risk D: Consider therapy modification
Immunosuppressants (Cytotoxic Chemotherapy): May diminish the therapeutic effect of Vaccines (Inactivated/Non-Replicating). Management: Give inactivated vaccines at least 2 weeks prior to initiation of chemotherapy when possible. Patients vaccinated less than 14 days before initiating or during chemotherapy should be revaccinated at least 3 months after therapy is complete. Risk D: Consider therapy modification
Immunosuppressants (Miscellaneous Oncologic Agents): May diminish the therapeutic effect of Vaccines (Inactivated/Non-Replicating). Management: Give inactivated vaccines at least 2 weeks prior to initiation of immunosuppressants when possible. Patients vaccinated less than 14 days before initiating or during therapy should be revaccinated at least 3 after therapy is complete. Risk D: Consider therapy modification
Immunosuppressants (Therapeutic Immunosuppressant Agents): May diminish the therapeutic effect of Vaccines (Inactivated/Non-Replicating). Management: Give inactivated vaccines at least 2 weeks prior to initiation of immunosuppressants when possible. Patients vaccinated less than 14 days before initiating or during therapy should be revaccinated at least 2 to 3 months after therapy is complete. Risk D: Consider therapy modification
Methotrexate: May diminish the therapeutic effect of Vaccines (Inactivated/Non-Replicating). Management: Administer vaccines at least 2 weeks prior to methotrexate initiation, if possible. If patients are vaccinated less than 14 days prior to or during methotrexate therapy, repeat vaccination at least 3 months after therapy if immunocompetence restored. Risk D: Consider therapy modification
Propacetamol: May diminish the therapeutic effect of Vaccines. Management: Consider avoiding routine prophylactic use of propacetamol before or during vaccine administration when possible. Propacetamol is still recommended to treat fevers and/or pain that occurs after vaccination. Risk D: Consider therapy modification
Siponimod: May diminish the therapeutic effect of Vaccines (Inactivated/Non-Replicating). Management: Avoid administration of vaccines (inactivated) during treatment with siponimod and for 1 month after discontinuation due to potential decreased vaccine efficacy. Risk D: Consider therapy modification
Teplizumab: May diminish the therapeutic effect of Vaccines (Inactivated/Non-Replicating). Management: Vaccination with inactivated or non-replicating vaccines is not recommended in the 2 weeks prior to teplizumab therapy, during treatment, or for 6 weeks following completion of therapy. Risk D: Consider therapy modification
An increased risk of adverse maternal or fetal events, including miscarriage or major birth defects, has not been observed following maternal use of the hepatitis B vaccine (Groom 2018).
The Advisory Committee on Immunization Practices recommends hepatitis B surface antigen (HBsAg) testing for all pregnant females. Pregnancy itself is not a contraindication to vaccination (CDC/ACIP [Schillie 2018a]). The Centers for Disease Control and Prevention recommends immunization for pregnant patients at risk for hepatitis B infection or severe outcome from infection during pregnancy (ACIP [Freedman 2020]). Refer to current immunization schedule for vaccinating pregnant females.
It is not known if the components of this vaccine are present in breast milk.
According to the manufacturer, the decision to continue or discontinue breastfeeding following immunization should consider the risk of infant exposure, the benefits of breastfeeding to the infant, and the benefits of vaccination to the mother. However, maternal vaccination is not a contraindication to breastfeeding (CDC [Schillie 2018a]). Administration does not affect the safety of breastfeeding for the mother or the infant. Breastfeeding infants should be vaccinated according to the recommended schedules (ACIP [Kroger 2023]). Infants born to hepatitis B surface antigen (HBsAg)-positive mothers (and who receive postexposure prophylaxis) or to mothers with unknown HBsAg status may be breastfed beginning immediately after birth. Female health care providers who are exposed to the hepatitis B virus do not need to discontinue breastfeeding when the vaccine is administered as part of post exposure care (CDC [Schillie 2018a]).
Monitor for hypersensitivity and syncope for 15 minutes following administration (ACIP [Kroger 2023]). If seizure-like activity associated with syncope occurs, maintain patient in supine or Trendelenburg position to reestablish adequate cerebral perfusion. In preterm infants, consider respiratory monitoring for 48 to 72 hours after administration.
Recombinant hepatitis B vaccine is a noninfectious subunit viral vaccine, which confers active immunity via formation of antihepatitis B antibodies. The vaccine is derived from hepatitis B surface antigen (HBsAg) produced through recombinant DNA techniques from yeast cells. The portion of the hepatitis B gene which codes for HBsAg is cloned into yeast, which is then cultured to produce hepatitis B vaccine.
Duration: Duration of protection against hepatitis B has been shown to be ≥30 years for immunocompetent persons who originally responded to the full three dose hepatitis B vaccine series (CDC/ACIP [Schillie 2018a]).
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