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
Trade Names: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
Induces specific antibodies against hepatitis B virus (HBV).
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.
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.
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 HBAdults 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.
Store refrigerated (36° to 46°F). Do not freeze; freezing destroys potency. Discard any vaccine that has been frozen.
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.
None well documented.
Palpitation, syncope, tachycardia (postmarketing).
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).
Alopecia, eczema, herpes zoster, purpura (postmarketing).Recombivax HB
Alopecia, herpes zoster, petechiae, Stevens-Johnson syndrome (postmarketing).
Conjunctivitis, earache, keratitis, tinnitus, vertigo, visual disturbances (postmarketing).Recombivax HB
Conjunctivitis, optic neuritis, tinnitus, visual disturbances (postmarketing).
Dyspepsia (postmarketing).Recombivax HB
Diarrhea, nausea (at least 1%); constipation (postmarketing).
Thrombocytopenia (postmarketing).Recombivax HB
Increased erythrocyte sedimentation rate, thrombocytopenia (postmarketing).
Abnormal LFTs (postmarketing).Recombivax HB
Elevated liver enzymes (postmarketing).
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.
Erythema, induration, swelling (1% to 10%).Recombivax HB
Soreness, including ecchymosis, erythema, nodule formation, pain, pruritus, swelling, tenderness, and warmth (at least 1%).
Transverse myelitis (postmarketing).Recombivax HB
Arthritis, muscle weakness, myelitis, including transverse myelitis (postmarketing).
Bronchospasm, including asthma-like symptoms (postmarketing).Recombivax HB
Pharyngitis, upper respiratory tract infection (at least 1%).
Fever (1% to 10%).Recombivax HB
Lupus-like syndrome, systemic lupus erythematosus, vasculitis (postmarketing).
Category C .
Safety and efficacy of Recombivax HB dialysis formulation have not been established.
Patients who develop symptoms suggestive of hypersensitivity after an injection should not receive further injections.
May require larger doses and may not respond to vaccine. Deferral of vaccination for 3 mo may be considered.
Delay use of hepatitis B vaccine in presence of serious active infection except when withholding vaccine entails greater risk.
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.
Although no casual relationship has been established, rare instances of MS exacerbation have been reported following administration of hepatitis vaccines and other vaccines.
Administer vaccine with caution.
May be present at time of vaccination and vaccine may not prevent hepatitis B because of long incubation period.
Copyright © 2009 Wolters Kluwer Health.