hepatitis b vaccine (Rx)

Brand and Other Names:Engerix B, Heplisav-B, more...Recombivax HB
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Dosing & Uses

AdultPediatric

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
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Interactions

Interaction Checker

and hepatitis b vaccine

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            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

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            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

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            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.

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            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)

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            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

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            Formulary

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            Tier Description
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            Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.