Hepatitis B Vaccine

Pronunciation: hep-ah-TYE-tiss
Class: Vaccine, viral

Trade Names

Engerix-B
- Injection (adult formulation) 20 mcg/mL hepatitis B surface antigen
- Injection (pediatric/adolescent formulation) 10 mcg per 0.5 mL hepatitis B surface antigen

Recombivax HB
- Injection (adult formulation) 10 mcg/mL hepatitis B surface antigen
- Injection (pediatric/adolescent formulation) 5 mcg per 0.5 mL hepatitis B surface antigen
- Injection (dialysis formulation) 40 mcg/mL hepatitis B surface antigen

Pharmacology

Induces specific antibodies against hepatitis B virus (HBV).

Indications and Usage

Induction of active immunity against all known subtypes of HBV among persons of all ages who are currently or who will be at increased risk of infection with this virus. Routine vaccination is recommended for infants and adolescents. All persons not previously vaccinated with hepatitis B vaccine are recommended to be vaccinated at 11 to 12 yr of age. In addition, vaccination is recommended in older unvaccinated adolescents at high risk. Vaccination is also indicated for those at high risk of exposure to or development of HBV, such as health care personnel; patients requiring frequent or large-volume blood transfusions or clotting factor concentrates; residents and staff of institutions for mentally handicapped; household and other intimate contacts of persons with persistent hepatitis B antigenemia; infants born to hepatitis B surface antigen (HBsAg)–positive mothers; populations with high incidence of HBV (eg, Alaskan Eskimos, Indochinese refugees, Haitian refugees, Pacific islanders); persons at increased risk because of their sexual practices (eg, prostitutes, persons who repeatedly contract STDs, homosexually active men, persons with multiple sexual partners); international travelers; morticians; embalmers; prisoners; users of illicit injectable drugs; police and fire department personnel who render first aid or medical assistance. Immunization with hepatitis B vaccine is recommended for persons with chronic hepatitis C.

Recombivax HB dialysis formulation

For vaccination of adult predialysis and dialysis patients.

Unlabeled Uses

Hepatitis B vaccination is appropriate for persons expected to receive human alpha-1 proteinase inhibitors that are produced from heat-treated, pooled human plasma that may contain the causative agents of hepatitis and other viral diseases.

Contraindications

Standard considerations.

Dosage and Administration

Engerix-B
Adults 20 yr of age and older

IM 20 mcg at 0, 1, and 6 mo.

Children and Adolescents 1 to 19 yr of age

IM 10 mcg at 0, 1, and 6 mo.

Infants of HBsAg-Positive or -Negative Mothers

IM 10 mcg at 0, 1, and 6 mo.

Adult Dialysis Patients

IM 40 mcg at 0, 1, 2, and 6 mo.

Alternate Schedule

Designed for certain populations (eg, neonates born of hepatitis B–infected mothers, others who may have been recently exposed to the virus, certain travelers to high-risk areas).

Adults (Older than 19 yr of Age)

IM 20 mcg at 0, 1, 2, and 12 mo.

Adolescents (11 to 19 yr of Age)

IM 20 mcg at 0, 1, 2, and 12 mo, or 20 mcg at 0, 1, and 6 mo.

Adolescents 11 to 16 yr of Age (For Whom an Extended Schedule is Acceptable Based on Risk of Exposure)

IM 10 mcg at 0, 12, and 24 mo.

Children (Birth to 10 yr of Age)

IM 10 mcg at 0, 1, 2, and 12 mo.

Children 5 to 10 yr of Age (For Whom an Extended Schedule is Acceptable Based on Risk of Exposure)

IM 10 mcg at 0, 12, and 24 mo.

Infants Born of HBsAG-Positive Mothers

IM 10 mcg at 0, 1, 2, and 12 mo.

Revaccination Hemodialysis patients

A booster dose may be considered for patients undergoing dialysis if anti-HBs level less than 10 milliunits/mL 1 to 2 mo after third dose.

Other patients (when a booster dose is appropriate) Adults and adolescents 11 yr of age and older

IM 20 mcg.

Children 10 yr of age or younger

IM 10 mcg.

Recombivax HB
Adults 20 yr of age and older

IM 10 mcg at 0, 1, and 6 mo.

Children and Adolescents 0 to 19 yr of age

IM 5 mcg at 0, 1, and 6 mo.

Adolescents 11 to 15 yr of age

IM 10 mcg at 0 and 4 to 6 mo.

Infants Born of HBsAg-Positive or -Negative Mothers

IM 5 mcg at 0, 1, and 6 mo.

Adult Predialysis and Dialysis Patients

IM 40 mcg at 0, 1, and 6 mo.

General Advice

  • Administer in deltoid muscle in adults. In neonates and infants, the anterolateral thigh may be preferable. Do not inject in the gluteal region.
  • May administer subcutaneous in patients at risk of hemorrhage from IM injection. However, response may be less than optimal, and there may be an increased risk of local reactions.
  • Inspect visually for particulate matter or discoloration prior to administration. With thorough agitation, vaccine is a slightly turbid/opaque, white suspension. Discard if it appears otherwise.
  • No dilution is necessary.
  • Engerix-B
  • Shake well before withdrawal and use.
  • Use full recommended dose of the vaccine.
  • Discard any vaccine remaining in a single-dose vial.
  • Recombivax HB
  • Shake well before use.
  • Thorough agitation at the time of administration is necessary to maintain suspension of the vaccine.
  • Because none of the formulations contain a preservative, once the single-dose vial has been penetrated, use the withdrawn vaccine promptly, and discard the vial.

Storage/Stability

Store refrigerated (36° to 46°F). Do not freeze; freezing destroys potency. Discard any vaccine that has been frozen.

Drug Interactions

Use with other vaccines

Simultaneous administration of certain live and inactivated pediatric vaccines has not resulted in impaired antibody responses or increased rates of adverse reactions. Separate sites and syringes should be used for simultaneous administration of injectable vaccines.

Laboratory Test Interactions

None well documented.

Adverse Reactions

Cardiovascular

Palpitation, syncope, tachycardia (postmarketing).

CNS

Engerix-B

Dizziness, headache (1% to 10%); migraine, multiple sclerosis (MS), neuropathy (including Bells palsy, Guillain-Barré syndrome, hypoesthesia, and paresthesia), paresis, seizures (postmarketing).

Recombivax HB

Fatigue/weakness, headache, malaise (at least 1%); agitation, encephalitis, exacerbation of MS, febrile seizures, Guillain-Barré syndrome, hypesthesia, irritability, migraine, MS, peripheral neuropathy (including Bells palsy), radiculopathy hypesthesia, seizures, somnolence (postmarketing).

Dermatologic

Engerix-B

Alopecia, eczema, herpes zoster, purpura (postmarketing).

Recombivax HB

Alopecia, herpes zoster, petechiae, Stevens-Johnson syndrome (postmarketing).

EENT

Engerix-B

Conjunctivitis, earache, keratitis, tinnitus, vertigo, visual disturbances (postmarketing).

Recombivax HB

Conjunctivitis, optic neuritis, tinnitus, visual disturbances (postmarketing).

GI

Engerix-B

Dyspepsia (postmarketing).

Recombivax HB

Diarrhea, nausea (at least 1%); constipation (postmarketing).

Hematologic-Lymphatic

Engerix-B

Thrombocytopenia (postmarketing).

Recombivax HB

Increased erythrocyte sedimentation rate, thrombocytopenia (postmarketing).

Hepatic

Engerix-B

Abnormal LFTs (postmarketing).

Recombivax HB

Elevated liver enzymes (postmarketing).

Hypersensitivity

Engerix-B

Hypersensitivity, including anaphylaxis, angioedema, arthritis, serum sickness–like reaction, delayed hypersensitivity syndrome including arthralgia/arthritis, fever, dermatologic reactions such as erythema multiforme (including Stevens-Johnson syndrome), ecchymosis, and erythema nodosum (postmarketing).

Recombivax HB

Hypersensitivity, including anaphylaxis and symptoms of immediate hypersensitivity reaction, including angioedema, bronchial spasm, chest discomfort, dyspnea, edema, hypersensitivity syndrome (serum sickness–like reaction) of delayed onset (including ecchymosis, erythema multiforme, erythema nodosum), palpitation, pruritus, rash, symptoms consistent with hypotensive episode, and urticaria.

Local

Engerix-B

Erythema, induration, swelling (1% to 10%).

Recombivax HB

Soreness, including ecchymosis, erythema, nodule formation, pain, pruritus, swelling, tenderness, and warmth (at least 1%).

Musculoskeletal

Engerix-B

Transverse myelitis (postmarketing).

Recombivax HB

Arthritis, muscle weakness, myelitis, including transverse myelitis (postmarketing).

Respiratory

Engerix-B

Bronchospasm, including asthma-like symptoms (postmarketing).

Recombivax HB

Pharyngitis, upper respiratory tract infection (at least 1%).

Miscellaneous

Engerix-B

Fever (1% to 10%).

Recombivax HB

Lupus-like syndrome, systemic lupus erythematosus, vasculitis (postmarketing).

Precautions

Pregnancy

Category C .

Lactation

Undetermined.

Children

Safety and efficacy of Recombivax HB dialysis formulation have not been established.

Hypersensitivity

Patients who develop symptoms suggestive of hypersensitivity after an injection should not receive further injections.

Immunosuppressed patients

May require larger doses and may not respond to vaccine. Deferral of vaccination for 3 mo may be considered.

Infection

Delay use of hepatitis B vaccine in presence of serious active infection except when withholding vaccine entails greater risk.

Latex

Engerix-B vial stopper is latex-free. The tip cap and the rubber plunger of the needleless prefilled syringes contain dry natural latex rubber that may cause allergic reactions in latex-sensitive persons.

MS

Although no casual relationship has been established, rare instances of MS exacerbation have been reported following administration of hepatitis vaccines and other vaccines.

Severely compromised cardiopulmonary status

Administer vaccine with caution.

Unrecognized hepatitis B infection

May be present at time of vaccination and vaccine may not prevent hepatitis B because of long incubation period.

Patient Information

  • Instruct patient or parent to complete the series of injections for vaccine to be effective.
  • Provide patient or parent with immunization history record and record this immunization in patient's medical records.
  • Instruct patient or parent to use antipyretics for fever or analgesics (eg, acetaminophen) for local pain.
  • Inform patient or parent of immunization schedule.

Copyright © 2009 Wolters Kluwer Health.

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