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Engerix-B
hepatitis B vaccine (recombinant) (HepB)
Adult Dosing .
Dosage forms: INJ
hepatitis B infection prevention, immunocompetent patients
- [<20 yo]
- Dose: 0.5 mL IM x1 at mo 0, 1, and 6 for 3 total doses; Info: may give SC if hemorrhage risk with IM; repeat series if anti-HBs level <10 milliunits/mL at least 1-2mo after 3rd dose in healthcare workers or patients with HBsAg-positive partner; search 'immunization' for epocrates Adult Immunization and CDC Pre-Travel Vaccine decision tools including links to CDC/ACIP schedules and recommendations; see pkg insert for alternative schedules for high-risk patients
- [20 yo and older]
- Dose: 1 mL IM x1 at mo 0, 1, and 6 for 3 total doses; Info: give to patients 60 yo and older with risk factors; may give to patients 60 yo and older without risk factors; may give SC if hemorrhage risk with IM; repeat series if anti-HBs level <10 milliunits/mL at least 1-2mo after 3rd dose in healthcare workers or patients with HBsAg-positive sex partner; search 'immunization' for epocrates Adult Immunization and CDC Pre-Travel Vaccine decision tools including links to CDC/ACIP schedules and recommendations; see pkg insert for alternative schedules for high-risk patients
hepatitis B infection prevention, immunocompromised patients (off-label)
- [patients with HIV infection]
- Dose: 2 mL IM x1 at mo 0, 1, and 6 for 3 total doses; Info: may give SC if hemorrhage risk with IM; repeat series if anti-HBs level <10 milliunits/mL at least 1-2mo after 3rd dose; refer to DHHS guidelines for dosing in patients with isolated anti-HBc
- [patients without HIV infection]
- Dose: 2 mL IM x1 at mo 0, 1, 2, and 6 for 4 total doses; Info: for patients 20 yo and older; may give SC if hemorrhage risk with IM; repeat series if anti-HBs level <10 milliunits/mL at least 1-2mo after 4th dose
renal dosing
- [<20 yo]
- renal impairment: consider incr. usual dose or frequency if eGFR <30
- HD/PD: no adjustment; no supplement
- [20 yo and older]
- renal impairment: consider incr. usual dose or frequency if eGFR <30
- HD/PD: 2 mL x1 at mo 0, 1, 2, and 6 for 4 total doses; repeat series if anti-HBs level <10 milliunits/mL 1-2mo after 4th dose; give 2 mL booster x1 if annual anti-HBs level <10 milliunits/mL; no supplement
hepatic dosing
- [no adjustment]
Peds Dosing .
- Dosage forms: INJ
hepatitis B infection prevention, primary
- [newborn with HBsAg-negative gestational parent]
- Dose: 0.5 mL IM x1 at birth, 1-2 mo, and 6-18 mo for 3 total doses; Start: within 24h of birth if wt >2 kg, otherwise at 1 mo or hospital discharge; Info: may give SC if hemorrhage risk with IM; search 'immunization' for epocrates Child/Adolescent Immunization and CDC Pre-Travel Vaccine decision tools including links to CDC/ACIP schedules and recommendations; see pkg insert for alternative schedules for high-risk patients
- [newborn with HBsAg-positive gestational parent]
- Dose: 0.5 mL IM x1 at birth, 1-2 mo, and 6-18 mo for 3 total doses; Start: within 12h of birth; Info: may give SC if hemorrhage risk with IM; give with hepatitis B immune globulin; if wt <2 kg, give 1 dose at birth, then start 3-dose series at 1 mo for 4 total doses; search 'immunization' for epocrates Child/Adolescent Immunization and CDC Pre-Travel Vaccine decision tools including links to CDC/ACIP schedules and recommendations; see pkg insert for alternative schedules for high-risk patients
- [newborn with HBsAg status unknown gestational parent]
- Dose: 0.5 mL IM x1 at birth, 1-2 mo, and 6-18 mo for 3 total doses; Start: within 12h of birth; Info: may give SC if hemorrhage risk with IM; if wt <2 kg, give 1 dose at birth with hepatitis B immune globulin, then start 3-dose series at 1 mo for 4 total doses; search 'immunization' for epocrates Child/Adolescent Immunization and CDC Pre-Travel Vaccine decision tools including links to CDC/ACIP schedules and recommendations; see pkg insert for alternative schedules for high-risk patients
- [immunocompetent patients]
- Dose: 0.5 mL IM x1 at mo 0, 1-2, and 6-18 for 3 total doses; Info: may give SC if hemorrhage risk with IM; search 'immunization' for epocrates Child/Adolescent Immunization and CDC Pre-Travel Vaccine decision tools including links to CDC/ACIP schedules and recommendations; see pkg insert for alternative schedules for high-risk patients
- [immunocompromised adolescents (off-label)]
- Dose: 2 mL IM x1 at mo 0, 1, and 6 for 3 total doses; Info: for patients with HIV infection; may give SC if hemorrhage risk with IM; repeat series if anti-HBs level <10 milliunits/mL at least 1-2mo after 3rd dose; refer to DHHS guidelines for dosing in patients with isolated anti-HBc
hepatitis B infection prevention, booster (off-label)
- [0.5 mL IM x1]
- Info: for patients >9 mo with HBsAg-positive or HBsAg status unknown gestational parent and anti-HBs level <10 milliunits/mL at least 1-2mo after last dose of primary series; may give SC if hemorrhage risk with IM; give subsequent doses per schedule to complete second series if anti-HBs level <10 milliunits/mL at least 1-2mo after booster dose
renal dosing
- [see below]
- renal impairment: consider incr. usual dose or frequency if eGFR <30
- HD/PD: no adjustment; no supplement
hepatic dosing
- [no adjustment]
Contraindications / Cautions .
- hypersensitivity to drug or ingredient
- hypersensitivity to yeast
- caution: immunocompromised patients
- caution: illness, acute moderate-severe
- caution: patients >60 yo
- caution: renal impairment
Drug Interactions .
Overview
hepatitis B vaccine
vaccine
- non-live vaccine
Avoid/Use Alternative
- interferon gamma 1b
Monitor/Modify Tx
- abatacept
- abemaciclib
- abrocitinib
- acalabrutinib
- adalimumab
- ado-trastuzumab emtansine
- afamitresgene autoleucel
- aldesleukin
- alemtuzumab
- amivantamab
- anakinra
- anifrolumab
- anti-thymocyte globulin
- asciminib
- atezolizumab
- atidarsagene autotemcel
- avelumab
- avutometinib
- axicabtagene ciloleucel
- azacitidine
- azathioprine
- baricitinib
- basiliximab
- belantamab mafodotin
- belatacept
- belimumab
- belinostat
- belzutifan
- bendamustine
- betamethasone
- bimekizumab
- blinatumomab
- bortezomib
- brentuximab vedotin
- brexucabtagene autoleucel
- brodalumab
- budesonide
- budesonide rectal
- busulfan
- cabazitaxel
- canakinumab
- capecitabine
- capmatinib
- carboplatin
- carfilzomib
- carmustine
- cemiplimab
- certolizumab pegol
- chlorambucil
- ciltacabtagene autoleucel
- cisplatin
- cladribine injection
- cladribine oral
- clofarabine
- copanlisib
- corticotropin
- cortisone
- cosibelimab
- cyclophosphamide
- cyclosporine
- cytarabine
- dactinomycin
- daratumumab
- dasatinib
- daunorubicin
- decitabine
- defactinib
- deflazacort
- delgocitinib topical
- deucravacitinib
- deuruxolitinib
- dexamethasone
- dimethyl fumarate
- dinutuximab
- diroximel fumarate
- docetaxel
- dordaviprone
- dostarlimab
- doxorubicin
- dupilumab
- durvalumab
- duvelisib
- efgartigimod alfa
- elivaldogene autotemcel
- elotuzumab
- elranatamab
- emapalumab
- epcoritamab
- epirubicin
- erdafitinib
- eribulin
- etanercept
- etoposide
- etrasimod
- etuvetidigene autotemcel
- everolimus
- fam-trastuzumab deruxtecan
- fingolimod
- floxuridine
- fludarabine
- fludrocortisone
- fluorouracil
- fruquintinib
- futibatinib
- gemcitabine
- gemtuzumab ozogamicin
- glofitamab
- golimumab
- guselkumab
- hydrocortisone
- hydroxyurea
- ibritumomab tiuxetan
- ibrutinib
- icotrokinra
- idarubicin
- idecabtagene vicleucel
- idelalisib
- ifosfamide
- imatinib
- inebilizumab
- infliximab
- inotuzumab ozogamicin
- ipilimumab
- irinotecan
- isatuximab
- ixabepilone
- ixekizumab
- lazertinib
- lebrikizumab
- leflunomide
- lenalidomide
- linvoseltamab
- lisocabtagene maraleucel
- lomustine
- loncastuximab tesirine
- lurbinectedin
- lymphocyte immune globulin, anti-thymocyte globulin
- margetuximab
- melphalan
- mercaptopurine
- methotrexate
- methylprednisolone
- mirikizumab
- mitomycin
- mitoxantrone
- mogamulizumab
- momelotinib
- monomethyl fumarate
- mosunetuzumab
- mycophenolate mofetil
- mycophenolic acid
- natalizumab
- nelarabine
- nemolizumab
- nilotinib
- nipocalimab
- nivolumab
- obecabtagene autoleucel
- obinutuzumab
- ocrelizumab
- ofatumumab
- olaparib
- oxaliplatin
- ozanimod
- paclitaxel
- palbociclib
- peginterferon alfa 2a
- pembrolizumab
- pemetrexed
- penpulimab
- pentostatin
- pertuzumab
- pirtobrutinib
- polatuzumab vedotin
- pomalidomide
- ponatinib
- ponesimod
- prednisolone
- prednisone
- procarbazine
- regorafenib
- retifanlimab
- revumenib
- rilonacept
- rilzabrutinib
- ripretinib
- risankizumab
- ritlecitinib
- rituximab
- romidepsin
- ropeginterferon alfa-2b
- rozanolixizumab
- rucaparib
- ruxolitinib
- sarilumab
- satralizumab
- secukinumab
- selinexor
- selumetinib
- sevabertinib
- sibeprenlimab
- siltuximab
- siponimod
- sirolimus
- sirolimus albumin-bound
- sirolimus topical
- sorafenib
- spesolimab
- sunitinib
- sunvozertinib
- tacrolimus
- tafasitamab
- taletrectinib
- talquetamab
- tarlatamab
- teclistamab
- telisotuzumab vedotin
- temozolomide
- temsirolimus
- teplizumab
- teriflunomide
- thioguanine
- thiotepa
- tildrakizumab
- tisagenlecleucel
- tislelizumab
- tocilizumab
- tofacitinib
- topotecan
- toripalimab
- trabectedin
- tralokinumab
- trastuzumab
- tremelimumab
- triamcinolone
- ublituximab
- upadacitinib
- ustekinumab
- vamorolone
- vandetanib
- vedolizumab
- venetoclax
- vinblastine
- vincristine
- vinorelbine
- voclosporin
- zanidatamab
- zanubrutinib
- zenocutuzumab
- ziftomenib
- zongertinib
Adverse Reactions .
Serious Reactions
- hypersensitivity reaction
- anaphylactoid reaction
- anaphylaxis
- erythema multiforme
- erythema nodosum
- Stevens-Johnson syndrome
- thrombocytopenia
- neurotoxicity
- Guillain-Barre syndrome
- encephalopathy
- seizures
- herpes zoster (shingles)
- meningitis
- lymphadenopathy
- hypotension
- alopecia
Common Reactions
- injection site reaction
- fatigue
- fever
- dizziness
- headache
Safety/Monitoring .
Monitoring Parameters
no routine tests recommended
Look/Sound-Alike Drug Names
Engerix-B confused with: Pediarix
hepatitis B vaccine, recombinant confused with: hepatitis A vaccine, inactivated; hepatitis B immune globulin; hepatitis B vaccine recombinant, adjuvanted
Pregnancy/Lactation .
Pregnancy
Clinical Summary
may use during pregnancy; risk of fetal harm not expected based on limited human data
Lactation
Clinical Summary
may use while breastfeeding; no human data available, though risk of infant harm not expected based on vaccine properties; no human data available to assess effects on milk production
Pharmacology .
Metabolism: for hepatitis B vaccine: other; CYP450: unknown
Excretion: for hepatitis B vaccine: unknown; Half-life: unknown
Subclass: Hepatitis B (HBV) Vaccines ; Routine Adult Vaccines ; Routine Pediatric Vaccines ; Travel Vaccines
Mechanism of Action
for hepatitis B vaccine: exact mechanism of action unknown; induces antibody formation
Formulary .
No Formulary Selected
Manufacturer/Pricing .
Manufacturer: GlaxoSmithKline
DEA/FDA: Rx
Retail Price
Estimated prices only. For current pricing, visit GoodRx.
intramuscular suspension:
- 20 mcg/mL (1 vial, 1 mL): $69.00
intramuscular suspension:
- 10 mcg/0.5 mL (1 syringe, 0.5 mL): $30.00
intramuscular suspension:
- 20 mcg/mL (1 syringe, 1 mL): $69.00
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