Dosage Forms
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]
Pharmacology
Mechanism of Action
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.
Pharmacokinetics/Pharmacodynamics
Duration of Action
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 2018]).
Use: Labeled Indications
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 2018]):
- All neonates (regardless of weight) born to either 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 requesting protection from HBV infection
- All unvaccinated adults at risk for HBV infection such as those with:
Behavioral risks: Sexually-active persons with >1 partner in a 6-month period; persons seeking evaluation or treatment for a sexually transmitted disease; men who have sex with men; injection drug users
Occupational risks: Healthcare personnel (HCP) and public safety workers with reasonably anticipated risk for exposure to blood or blood contaminated body fluids
Medical risks: Persons with end-stage renal disease (including predialysis, hemodialysis, peritoneal dialysis, and home dialysis); persons with HIV infection; persons with chronic liver disease (eg, hepatitis C virus infection, cirrhosis, fatty liver disease, alcoholic liver disease, autoimmune hepatitis, ALT or AST level >2 times the upper limit of normal). Adults (19 through 59 years of age) with diabetes mellitus type 1 or type 2 should be vaccinated as soon as possible following diagnosis. Adults ≥60 years with diabetes mellitus may also be vaccinated at the discretion of their treating clinician based on the likelihood of acquiring HBV infection.
Other risks: Household contacts or sex partners of persons who are HBsAg-positive; residents and staff of facilities for developmentally disabled persons; 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]).
Contraindications
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.
Dosage and Administration
Dosing: Adult
Primary immunization: IM: 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 (both 1 mL). Recombivax HB adult formulation contains 10 mcg/mL and Recombivax HB dialysis formulation contains 40 mcg/mL; See Dosing: Renal Impairment for dosing in adult patients with chronic kidney disease and/or dialysis.
Immunocompetent adults (non-dialysis): 1 mL/dose (adult formulation) for 3 total doses administered at 0, 1, and 6 months. Note: Refer to CDC guidelines (CDC/ACIP [Schillie 2018]) for other options. Manufacturer labeling may 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 (AASLD [Terrault 2018]; CDC/ACIP [Schillie 2018]; HHS 2018; IDSA [Rubin 2014]).
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
Revaccination (CDC/ACIP [Schillie 2018]): IM:
Healthcare professionals (HCP): For HCPs completely vaccinated and with anti-HBs levels <10 milliunits/mL, administer an additional hepatitis B dose; perform anti-HBs testing 1 to 2 months later. If anti-HBs levels remain <10 milliunits/mL, complete the vaccine series; perform anti-HBs testing 1 to 2 months later. Alternatively, HCPs with anti-HBs levels <10 milliunits/mL may receive a second, complete 3-dose vaccination series followed by a reassessment of anti-HBs levels 1 to 2 months after the final dose.
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 (CDC [Chapman 2008]).
Postexposure management of health care personnel (HCP) (CDC/ACIP [Schillie 2018]): 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.
Postexposure management in nonoccupational settings (CDC/ACIP [Schillie 2018]): 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.
Dosing: Geriatric
Refer to adult dosing.
Dosing: Pediatric
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 (CDC/ACIP [Schillie 2018]).
Primary immunization:
CDC (ACIP) recommendations (CDC/ACIP [Schillie 2018]): 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: Former premature neonates <2 kg should have the initial dose deferred up to 30 days of chronological age or at hospital discharge.
Infants born to HBsAg-positive mothers:
Former term neonates and infants should receive the usual 3-dose series; preterm neonates should receive a 4-dose series due to potential decreased immunogenicity.
First dose: 0.5 mL within first 12 hours of life, even if premature and 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 (eg, preterm): At 1 month of age
Birthweight ≥2 kg (eg, term): At 1 to 2 months of age
Third dose: 0.5 mL, timing of dose dependent on birthweight:
Birthweight <2 kg (eg, preterm): At 2 to 3 months of age
Birthweight ≥2 kg (eg, term): 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 (eg, preterm): 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 (eg, preterm): 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 (eg, term): 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 (CDC/ACIP [Schillie 2018]) 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.
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 (CDC [Chapman 2008])
Administration
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 (both 1 mL). It is possible to interchange the vaccines for completion of a series or for booster doses; the antibody produced in response to each type of vaccine is comparable, however, the quantity of the vaccine will vary.
IM injection (preferred); do not administer IV or intradermally; the deltoid muscle is the preferred site. 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 (ACIP [Kroger 2017]). US law requires that the date of administration, the vaccine manufacturer, lot number of vaccine, and the administering person's name, title, and address be entered into the patient's permanent medical record.
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 (ACIP [Kroger 2017]).
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 (CDC/ACIP [Schillie 2018]).
Storage
Engerix-B: Refrigerate at 2°C to 8°C (36°F to 46°F). Do not freeze; discard if product has been frozen. Extended storage information at room temperature may be available; contact product manufacturer to obtain current recommendations.
Recombivax HB: Refrigerate at 2°C to 8°C (36°F to 46°F); may be stored at 0°C to 25°C (32°F to 75°F) for ≤72 hours. Do not freeze; discard if product has been frozen. Protect from light.
Drug Interactions
Fingolimod: May diminish the therapeutic effect of Vaccines (Inactivated). 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. Consider therapy modification
Immunosuppressants: May diminish the therapeutic effect of Vaccines (Inactivated). Management: Vaccine efficacy may be reduced. Complete all age-appropriate vaccinations at least 2 weeks prior to starting an immunosuppressant. If vaccinated during immunosuppressant therapy, revaccinate at least 3 months after immunosuppressant discontinuation. Exceptions: Cytarabine (Liposomal). Consider therapy modification
Siponimod: May diminish the therapeutic effect of Vaccines (Inactivated). Management: Avoid administration of vaccines (inactivated) during treatment with siponimod and for 1 month after discontinuation due to potential decreased vaccine efficacy. Consider therapy modification
Venetoclax: May diminish the therapeutic effect of Vaccines (Inactivated). Monitor therapy
Test Interactions
Following vaccination, hepatitis B surface antigen (HBsAg), a component of the vaccine, has been transiently detected in blood samples. Therefore, serum HBsAg detection may not have diagnostic value within 28 days after receipt of hepatitis B vaccine.
Adverse Reactions
All serious adverse reactions must be reported to the US Department of Health and Human Services (DHHS) Vaccine Adverse Event Reporting System (VAERS) at 1-800-822-7967 or online at https://vaers.hhs.gov/.
Frequency not defined. The most common adverse effects reported with both products included injection site reactions (>10%).
Cardiovascular: Flushing, hypotension
Central nervous system: Body pain, chills, dizziness, drowsiness, fatigue, headache, insomnia, irritability, malaise, paresthesia, tingling sensation, vertigo
Dermatologic: Diaphoresis, pruritus, skin rash, urticaria
Gastrointestinal: Abdominal pain, anorexia, decreased appetite, diarrhea, dyspepsia, nausea, stomach cramps, vomiting
Genitourinary: Dysuria
Hematologic & oncologic: Lymphadenopathy
Hypersensitivity: Angioedema
Infection: Influenza
Local: Bruising at injection site, erythema at injection site, induration at injection site, injection site nodule, itching at injection site, local soreness/soreness at injection site, pain at injection site, swelling at injection site, tenderness at injection site, warm sensation at injection site
Neuromuscular & skeletal: Arthralgia, back pain, myalgia, neck pain, neck stiffness, shoulder pain, weakness
Otic: Otalgia
Respiratory: Cough, pharyngitis, rhinitis, upper respiratory tract infection
Miscellaneous: Fever (≥37.5°C/100°F)
Postmarketing and/or case reports: Abnormal hepatic function tests, acute exacerbations of multiple sclerosis, agitation, alopecia, anaphylactoid reaction, anaphylaxis, apnea, arthritis, Bell's palsy, brain disease, bronchospasm, conjunctivitis, constipation, convulsions, eczema, encephalitis, erythema nodosum, erythema multiforme, febrile seizures, Guillain-Barre syndrome, herpes zoster, hypersensitivity reaction, hypoesthesia, increased erythrocyte sedimentation rate, increased liver enzymes, keratitis, lichen planus, limb pain, lupus-like syndrome, meningitis, migraine, multiple sclerosis, myasthenia, myelitis, neuritis, neuropathy, optic neuritis, palpitations, paralysis, paresis, periarteritis nodosa, peripheral neuropathy, petechiae, purpura, radiculopathy, seizure, serum sickness-like reaction (may be delayed days to weeks), Stevens-Johnson syndrome, syncope, systemic lupus erythematosus, tachycardia, thrombocytopenia, tinnitus, transverse myelitis, uveitis, vasculitis, visual disturbance
Warnings/Precautions
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 2017]).
- 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 2017]).
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. Defer 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 2017]). 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 2017]).
- 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: Consider deferring immunization during periods of severe immunosuppression (eg, patients receiving chemo/radiation therapy or other immunosuppressive therapy [including high-dose corticosteroids]); may have a reduced response to vaccination. In general, household and close contacts of persons with altered immunocompetence may receive all age appropriate vaccines. Inactivated vaccines should be administered ≥2 weeks prior to planned immunosuppression when feasible; inactivated vaccines administered during chemotherapy should be readministered after immune competence is regained (ACIP [Kroger 2017]; IDSA [Rubin 2014]).
- Elderly: Patients >60 years of age may have lower response rates (CDC/ACIP [Schillie 2018]).
- Pediatric: In general, preterm infants should be vaccinated at the same chronological age as full-term infants (ACIP [Kroger 2017]). 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 2018]). Apnea has been reported following IM vaccine administration in premature infants; consider clinical status implications (ACIP [Kroger 2017]).
Concurrent drug therapy issues:
- Anticoagulant therapy: Use with caution in patients receiving anticoagulant therapy; bleeding/hematoma may occur from IM administration (ACIP [Kroger 2017]).
- 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 inactivated) for which a person is eligible at a single clinic visit, unless contraindications exist. The use of combination vaccines is generally preferred over separate injections, taking into consideration provider assessment, patient preference, and adverse events. When using combination vaccines, the minimum age for administration is the oldest minimum age for any individual component; the minimum interval between dosing is the greatest minimum interval between any individual components. 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 2017]).
Dosage form specific issues:
- Latex: 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 2017]). 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. Vaccines may not be effective if administered during periods of altered immune competence (ACIP [Kroger 2017]). 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.
Monitoring Parameters
Monitor for anaphylaxis and syncope for 15 minutes following administration (ACIP [Kroger 2017]). 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.
Pregnancy
Pregnancy Considerations
Available data do not suggest an increased risk of major birth defects or miscarriage following maternal use of hepatitis B vaccine.
The ACIP recommends HBsAg testing for all pregnant females. Pregnancy itself is not a contraindication to vaccination; vaccination is recommended for those identified as being at risk for HBV infection (CDC/ACIP [Schillie 2018]). Refer to current immunization schedule for vaccinating pregnant females.
Patient Education
What is this drug used for?
- It is used to prevent hepatitis B infection.
Frequently reported side effects of this drug
- Injection site pain, swelling, or redness
- Fatigue
- Loss of strength and energy
- Headache
- Irritability (children)
- Diarrhea (children)
- Lack of appetite (children)
- Runny nose (children)
Other side effects of this drug: Talk with your doctor right away if you have any of these signs of:
- Burning or numbness feeling
- Severe dizziness
- Passing out
- Abnormal movements
- High fever
- Vision changes
- Signs of a significant reaction like wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat.
Note: This is not a comprehensive list of all side effects. Talk to your doctor if you have questions.
Consumer Information Use and Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using this medicine.
