Dosing & Uses
Dosage Forms & Strengths
IM suspension (adult formulation)
- 10mcg/mL (Recombivax HB)
- 20mcg/mL (Engerix B)
- 40mcg/mL (Recombivax HB [dialysis formulation])
IM solution
- Adult adjuvanted formulation (Heplisav-B)
- 20mcg HBsAg and 3000mcg of CpG 1018 adjuvant per 0.5mL
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
- 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 receiving dialysis or other immunocompromising conditions
- Recombivax HB (40 mcg/mL): 40 mcg IM at 0, 1, and 6 months, OR
- Engerix-B (20 mcg/mL): 40 mcg IM at 0, 1, and 6 months
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
Dosing Considerations
Routine immunization against hepatitis B; also protects against hepatitis D which always occurs in the presence of hepatitis B
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

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
Images
Patient Handout
Formulary
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