Dosing & Uses
Dosage Forms & Strengths
IM suspension, 3-antigen
- 10mcg/mL (PreHevbrio)
IM suspension, single-antigen (adult formulation)
- 10mcg/mL (Recombivax HB)
- 20mcg/mL (Engerix B)
- 40mcg/mL (Recombivax HB [dialysis formulation])
IM solution, single-antigen
- 20mcg HBsAg and 3000mcg of CpG 1018 adjuvant per 0.5mL (Heplisav-B)
Hepatitis B Immunization
3-dose series
- Engerix B: 1 mL (20 mcg) IM at 0, 1, and 6 months
- Recombivax HB: 1 mL (10 mcg) IM at 0, 1, and 6 months
- PreHevbrio: 1 mL IM at 0, 1, and 6 months
- Heplisav-B: Can be used as a substitute in a 3-dose series with a different hepatitis B vaccine
2-dose series
- Heplisav-B (aged ≥18 years): 0.5 mL IM at 0 and 1 month
Adults with diabetes mellitus
- CDC ACIP guidelines recommends immunization with hepatitis B vaccine for all unvaccinated adults with diabetes mellitus through age 59 years
- Persons with diabetes are at increased risk of hepatitis B infection
- Vaccinate diabetics aged ≥60 yr at the discretion of the treating clinician, based on increased need for assisted blood glucose monitoring in long-term care facilities, likelihood of acquiring hepatitis B infection, its complications or chronic sequelae, and likelihood of immune response to vaccination
- Vaccination for older unvaccinated diabetic patients may be done at the physician's discretion MMWR Dec 23, 2011/Vol 60(50);1709-11
Dosage Modifications
-
Adults receiving dialysis or other immunocompromising conditions
-
Engerix B or Recombivax HB
- Primary immunization consists of a series of 4 doses (40 mcg) at 0, 1, 2, and 6 months
- Antibody response is lower in patients on hemodialysis compare with healthy persons and protection may persist only as long as antibody levels remain above 10 mIU/mL
- Assess need for booster doses by annual antibody testing
- Administer 2-mL booster dose for antibody levels <10 mIU/mL
Dosing Considerations
Routine immunization against hepatitis B; also protects against hepatitis D which always occurs in the presence of hepatitis B
Single-antigen vaccines: Engerix B, Heplisav-B (adjuvanted), Recombivax HB
3-antigen vaccine: PreHevbrio
Targeted groups that should receive HepB vaccination series include
- Sexually active persons who are not in a long-term, mutually monogamous relationship persons seeking evaluation or treatment for a sexually transmitted disease (STD); current or recent injection-drug users; and men who have sex with men
- Health-care personnel and public-safety workers who are potentially exposed to blood or other infectious body fluids
- Persons with diabetes, HIV infection, or chronic liver disease
- Persons with end-stage renal disease, including patients receiving hemodialysis
- Household contacts and sex partners of hepatitis B surface antigen-positive persons; clients and staff members of institutions for persons with developmental disabilities; and international travelers to countries with high or intermediate prevalence of chronic HBV infection
- All adults in the following settings: STD treatment facilities; HIV testing and treatment facilities; facilities providing drug-abuse treatment and prevention services; health-care settings targeting services to injection-drug users or men who have sex with men; correctional facilities; end-stage renal disease programs and facilities for chronic hemodialysis patients; and institutions and nonresidential daycare facilities for persons with developmental disabilities
- Pregnant women who are at risk for hepatitis B virus infection during pregnancy (eg, >1 sex partner during the previous 6 months, been evaluated or treated for a sexually transmitted infection, recent or current injection drug use, or had an HBsAg-positive sex partner)
- International travelers to regions with high or intermediate levels of endemic hepatitis B virus infection should receive a HepB series
Additional Information
Current vaccination schedules available at http://www.cdc.gov/vaccines/schedules/hcp/index.html
Dosage Forms & Strengths
IM suspension (pediatric/adolescent formulations)
- 5mcg/0.5mL (Recombivax HB)
- 10mcg/0.5mL (Engerix B)
Hepatitis B Immunization
Primary immunization
First dose
- Medically stable infants weighing ≥2,000 grams born to HBsAg-negative mothers: 0.5 ML IM within 24h of birth
- Preterm infants weighing <2,000 g born to HBsAg-negative mothers: 0.5 mL IM 1 month after birth or at hospital discharge
- Infants born to HBsAg-positive mothers: 0.5 mL IM within 12 hr of birth PLUS hepatitis B immune globulin (HBIG); test for HBsAg and antibody to HBsAg (anti-HBs) 1-2 months after completion of hepatitis B vaccination series, at age 9 through 18 months
- Mother's HBsAg status unknown: 0.5 mL IM within 12 hr of birth PLUS give HBIG; if newborn wt <2 kg, determine mother's HBsAg status as soon as possible and, if she is HBsAg-positive, also administer HBIG for infants weighing 2 kg or more (no later than age 1 week)
Second dose
- Administered at age 1-2 months Monovalent HepB vaccine should be used for doses administered before age 6 weeks
- Infants who did not receive a birth dose should receive 3 doses of a HepB-containing vaccine on a schedule of 0, 1 to 2 months, and 6 months starting as soon as feasible
- Minimum interval between dose 1 and dose 2 is 4 weeks, and between dose 2 and 3 is 8 weeks
Final (3rd or 4th) dose
- Administered no earlier than age 24 weeks, and at least 16 weeks after the first dose
- A total of 4 doses of HepB vaccine is recommended when a combination vaccine containing HepB is administered after the birth dose
Catch-up schedule
- Unvaccinated children should complete a 3-dose series
- Children aged 11-15 years: 2-dose series (doses separated by at least 4 months) of adult formulation
- Recombivax HB is licensed for use in children aged 11 through 15 years
Interactions
Interaction Checker
No Results
Contraindicated
Serious - Use Alternative
Significant - Monitor Closely
Minor
Contraindicated (1)
- belimumab
belimumab decreases effects of hepatitis b vaccine by immunosuppressive effects; risk of infection. Contraindicated. Do not administer live vaccines 30 days before or concurrently with belimumab.
Serious - Use Alternative (37)
- adalimumab
adalimumab decreases effects of hepatitis b vaccine by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.
- alefacept
alefacept decreases effects of hepatitis b vaccine by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.
- anakinra
anakinra decreases effects of hepatitis b vaccine by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.
- antithymocyte globulin equine
antithymocyte globulin equine decreases effects of hepatitis b vaccine by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.
- antithymocyte globulin rabbit
antithymocyte globulin rabbit decreases effects of hepatitis b vaccine by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.
- azathioprine
azathioprine decreases effects of hepatitis b vaccine by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.
- basiliximab
basiliximab decreases effects of hepatitis b vaccine by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.
- budesonide
budesonide decreases effects of hepatitis b vaccine by pharmacodynamic antagonism. Contraindicated. Corticosteroids also increase risk of infection with concomitant live vaccines.
- canakinumab
canakinumab decreases effects of hepatitis b vaccine by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.
- cortisone
cortisone decreases effects of hepatitis b vaccine by pharmacodynamic antagonism. Contraindicated. Corticosteroids also increase risk of infection with concomitant live vaccines.
- deflazacort
deflazacort decreases effects of hepatitis b vaccine by pharmacodynamic antagonism. Contraindicated. Corticosteroids also increase risk of infection with concomitant live vaccines.
- dexamethasone
dexamethasone decreases effects of hepatitis b vaccine by pharmacodynamic antagonism. Contraindicated. Corticosteroids also increase risk of infection with concomitant live vaccines.
- etanercept
etanercept decreases effects of hepatitis b vaccine by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.
- everolimus
everolimus decreases effects of hepatitis b vaccine by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.
- fludrocortisone
fludrocortisone decreases effects of hepatitis b vaccine by pharmacodynamic antagonism. Contraindicated. Corticosteroids also increase risk of infection with concomitant live vaccines.
- glatiramer
glatiramer decreases effects of hepatitis b vaccine by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.
- golimumab
golimumab decreases effects of hepatitis b vaccine by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.
- hydrocortisone
hydrocortisone decreases effects of hepatitis b vaccine by pharmacodynamic antagonism. Contraindicated. Corticosteroids also increase risk of infection with concomitant live vaccines.
- hydroxychloroquine sulfate
hydroxychloroquine sulfate decreases effects of hepatitis b vaccine by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.
- infliximab
infliximab decreases effects of hepatitis b vaccine by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.
- leflunomide
leflunomide decreases effects of hepatitis b vaccine by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.
- methylprednisolone
methylprednisolone decreases effects of hepatitis b vaccine by pharmacodynamic antagonism. Contraindicated. Corticosteroids also increase risk of infection with concomitant live vaccines.
- muromonab CD3
muromonab CD3 decreases effects of hepatitis b vaccine by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.
- mycophenolate
mycophenolate decreases effects of hepatitis b vaccine by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.
- ocrelizumab
ocrelizumab decreases effects of hepatitis b vaccine by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Vaccination with live-attenuated or live vaccines is not recommended during ocrelizumab treatment and until B-cell repletion.
- ofatumumab SC
ofatumumab SC decreases effects of hepatitis b vaccine by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Administer all immunizations according to immunization guidelines at least 2 weeks before initiating ofatumumab SC for inactivated vaccines, and whenever possible.
- prednisolone
prednisolone decreases effects of hepatitis b vaccine by pharmacodynamic antagonism. Contraindicated. Corticosteroids also increase risk of infection with concomitant live vaccines.
- prednisone
prednisone decreases effects of hepatitis b vaccine by pharmacodynamic antagonism. Contraindicated. Corticosteroids also increase risk of infection with concomitant live vaccines.
- rilonacept
rilonacept decreases effects of hepatitis b vaccine by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.
- secukinumab
secukinumab decreases effects of hepatitis b vaccine by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Prior to initiating secukinumab, complete all age appropriate immunizations; non-live vaccinations received during treatment with secukinumab may not elicit an immune response sufficient to prevent disease.
- siponimod
siponimod decreases effects of hepatitis b vaccine by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Pause vaccinations beginning 1 week before initiating siponimod and for 4 weeks after stopping treatment. Coadministration with live attenuated vaccines may increase infection risk.
- sirolimus
sirolimus decreases effects of hepatitis b vaccine by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.
- tacrolimus
tacrolimus decreases effects of hepatitis b vaccine by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.
- temsirolimus
temsirolimus decreases effects of hepatitis b vaccine by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.
- tocilizumab
tocilizumab decreases effects of hepatitis b vaccine by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.
- triamcinolone acetonide injectable suspension
triamcinolone acetonide injectable suspension decreases effects of hepatitis b vaccine by pharmacodynamic antagonism. Contraindicated. Corticosteroids also increase risk of infection with concomitant live vaccines.
- ustekinumab
ustekinumab decreases effects of hepatitis b vaccine by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.
Monitor Closely (17)
- cyclosporine
cyclosporine decreases effects of hepatitis b vaccine by pharmacodynamic antagonism. Modify Therapy/Monitor Closely. If possible, complete all age-appropriate vaccinations at least 2 weeks before initiating immunosuppressant therapy. Patients vaccinated <14 days before starting immunosuppressive therapy or during immunosuppressive therapy should be revaccinated at least 3 months after therapy is discontinued if immune competence has been restored. Longer waiting periods may be required for drugs that maintain their immunosuppressive effects for more than 3 months after discontinuation (eg, ocrelizumab). .
- dengue vaccine
dengue vaccine, hepatitis b vaccine. unspecified interaction mechanism. Use Caution/Monitor. Data are not available to establish safety and immunogenicity of coadministration of dengue vaccine with recommended adolescent vaccines.
- ibrutinib
ibrutinib decreases effects of hepatitis b vaccine by immunosuppressive effects; risk of infection. Modify Therapy/Monitor Closely. Coadministration with immunosuppressant therapy reduced efficacy of the vaccine may occur. If possible, complete all age-appropriate vaccinations at least 2 weeks prior to initiation of immunosuppressant therapy. Patients vaccinated <14 days before initiation or during immunosuppressive therapy should be revaccinated at least 3 months after therapy is discontinued. .
- ifosfamide
ifosfamide decreases effects of hepatitis b vaccine by immunosuppressive effects; risk of infection. Modify Therapy/Monitor Closely. Coadministration with immunosuppressant therapy reduced efficacy of the vaccine may occur. If possible, complete all age-appropriate vaccinations at least 2 weeks prior to initiation of immunosuppressant therapy. Patients vaccinated <14 days before initiation or during immunosuppressive therapy should be revaccinated at least 3 months after therapy is discontinued. .
- lomustine
lomustine decreases effects of hepatitis b vaccine by pharmacodynamic antagonism. Modify Therapy/Monitor Closely. Coadministration with immunosuppressant therapy reduced efficacy of the vaccine may occur. If possible, complete all age-appropriate vaccinations at least 2 weeks prior to initiation of immunosuppressant therapy. Patients vaccinated <14 days before initiation or during immunosuppressive therapy should be revaccinated at least 3 months after therapy is discontinued. .
- mechlorethamine
mechlorethamine decreases effects of hepatitis b vaccine by immunosuppressive effects; risk of infection. Modify Therapy/Monitor Closely. Coadministration with immunosuppressant therapy reduced efficacy of the vaccine may occur. If possible, complete all age-appropriate vaccinations at least 2 weeks prior to initiation of immunosuppressant therapy. Patients vaccinated <14 days before initiation or during immunosuppressive therapy should be revaccinated at least 3 months after therapy is discontinued. .
- melphalan
melphalan decreases effects of hepatitis b vaccine by pharmacodynamic antagonism. Modify Therapy/Monitor Closely. Coadministration with immunosuppressant therapy reduced efficacy of the vaccine may occur. If possible, complete all age-appropriate vaccinations at least 2 weeks prior to initiation of immunosuppressant therapy. Patients vaccinated <14 days before initiation or during immunosuppressive therapy should be revaccinated at least 3 months after therapy is discontinued. .
- mercaptopurine
mercaptopurine decreases effects of hepatitis b vaccine by pharmacodynamic antagonism. Use Caution/Monitor. Immunosuppressants also increase risk of infection with concomitant live vaccines.
- methotrexate
methotrexate decreases effects of hepatitis b vaccine by pharmacodynamic antagonism. Use Caution/Monitor. Concomitant administration of methotrexate can decrease the immunological response of vaccines.
- onasemnogene abeparvovec
onasemnogene abeparvovec decreases effects of hepatitis b vaccine by immunosuppressive effects; risk of infection. Modify Therapy/Monitor Closely. Adjust vaccinations to accommodate concomitant corticosteroid administration prior to and following onasemnogene abeparvovec infusion. When initiating systemic corticosteriod therapy, wait 2 weeks after an inactivated vaccine.
- oxaliplatin
oxaliplatin decreases effects of hepatitis b vaccine by pharmacodynamic antagonism. Modify Therapy/Monitor Closely. Coadministration with immunosuppressant therapy reduced efficacy of the vaccine may occur. If possible, complete all age-appropriate vaccinations at least 2 weeks prior to initiation of immunosuppressant therapy. Patients vaccinated <14 days before initiation or during immunosuppressive therapy should be revaccinated at least 3 months after therapy is discontinued. .
- ponesimod
ponesimod decreases effects of hepatitis b vaccine by immunosuppressive effects; risk of infection. Use Caution/Monitor. If possible, complete all age-appropriate vaccinations at least 4 weeks before initiating ponesimod.
- procarbazine
procarbazine decreases effects of hepatitis b vaccine by immunosuppressive effects; risk of infection. Modify Therapy/Monitor Closely. Coadministration with immunosuppressant therapy reduced efficacy of the vaccine may occur. If possible, complete all age-appropriate vaccinations at least 2 weeks prior to initiation of immunosuppressant therapy. Patients vaccinated <14 days before initiation or during immunosuppressive therapy should be revaccinated at least 3 months after therapy is discontinued. .
- rituximab
rituximab, hepatitis b vaccine. immunosuppressive effects; risk of infection. Use Caution/Monitor. When used for rheumatoid arthritis, follow current immunization guidelines and administer non-live vaccines at least 4 weeks prior to a course of rituximab.
- rituximab-hyaluronidase
rituximab-hyaluronidase, hepatitis b vaccine. immunosuppressive effects; risk of infection. Use Caution/Monitor. When used for rheumatoid arthritis, follow current immunization guidelines and administer non-live vaccines at least 4 weeks prior to a course of rituximab.
- tralokinumab
tralokinumab will decrease the level or effect of hepatitis b vaccine by immunosuppressive effects; risk of infection. Use Caution/Monitor. Limited data are available regarding coadministration with non-live vaccines.
- voclosporin
voclosporin decreases effects of hepatitis b vaccine by immunosuppressive effects; risk of infection. Modify Therapy/Monitor Closely. Inactivated vaccines noted to be safe for administration may not be sufficiently immunogenic during treatment.
Minor (2)
- chloroquine
chloroquine decreases effects of hepatitis b vaccine by pharmacodynamic antagonism. Minor/Significance Unknown.
- ozanimod
ozanimod decreases effects of hepatitis b vaccine by immunosuppressive effects; risk of infection. Minor/Significance Unknown. No clinical data are available on the efficacy and safety of vaccinations in patients taking ozanimod. Vaccinations may be less effective if coadministered with ozanimod.
Adverse Effects
Suspected adverse events after administration of any vaccine may be reported to Vaccine Adverse Events Reporting System (VAERS), 1-800-822-7967
>10%
Pain (10-29%)
Pruritus (10-29%)
Erythema (10-29%)
Burning (10-29%)
Nodules (10-29%)
Fatigue (15%)
Headache (15%)
Fever (15%)
Vertigo (15%)
1-10%
Lightheadedness
Flushinig
Insomnia
Irritability
Arthralgia
Constipation
Pruritus
Lupus-like syndrome
Lymphadenopathy
Tachycardia
Warnings
Contraindications
Severe allergic reaction (eg, anaphylaxis) after a previous dose of any hepatitis B vaccine or to any vaccine component, including yeast
Cautions
Allergic reactions reported; appropriate medical treatment and supervision must be available to manage possible anaphylactic reactions following administration
Immunocompromised persons, including individuals receiving immunosuppressant therapy, may have a diminished immune response
Hepatitis B has a long incubation period; immunization may not prevent hepatitis B infection in individuals who have an unrecognized hepatitis B infection at the time of vaccine administration
Pregnancy & Lactation
Pregnancy
There are no clinical studies of hepatitis B in pregnant women
There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to Heplisav-B during pregnancy; women are encouraged to contact 1-844-443-7734
Lactation
Unknown if excreted in human milk
Pregnancy Categories
A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk. C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done. D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk. X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist. NA: Information not available.Pharmacology
Mechanism of Action
Hepatitis B surface antigen (HBsAg) which stimulates active immunity
Pharmacokinetics
Duration: Not established
Excretion: Not established
These products convey active immunity via stimulation of production of endogenously produced antibodies
The onset of protection from disease is relatively slow, but duration is long lasting (years)
Administration
IM Administration
Do not give IV or intradermal
Older children, adolescents, and adults: Administer IM in deltoid muscle
Neonates, infants, and small children: Administer IM in anterolateral thigh
SC Administration
Engerix B or Recombivax HB may be administered SC to persons at risk for hemorrhage following IM injections (eg, hemophiliacs)
SC administration known to result in lower antibody response
Increased incidence of local reactions, including SC nodules, observed when other aluminum-adsorbed vaccines have been administered SC
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