Vaccine Pregnancy: Can be used during pregnancy only when clearly needed and possible advantages outweigh potential risks to the foetus. Breast-feeding: use only when possible advantages outweigh potential risks.

Hepatitis B vaccine

Brand names: Engerix B, HBvaxPro, Fendrix

Hepatitis B vaccine is a recombinant vaccine used for active immunisation against hepatitis B virus, given as part of the routine childhood schedule and to adults at increased occupational or clinical risk.

Auto-extracted from the source labelling — not yet independently clinician-verified. These values were distilled from the UK SPC (or the US label where noted) but have not had a clinician sign-off. Confirm against the current SmPC before prescribing.

Adult dose

Dose: 1.0 ml per dose (for subjects from 1 year up to and including 15 years of age)

Route: Intramuscular injection, usually into the deltoid muscle (anterolateral thigh in very young subjects)

Frequency: Two-dose primary course: first dose at elected date, second dose between 6 and 12 months after the first dose

IMPORTANT: The eMC source SPC is for Ambirix, a COMBINED hepatitis A and hepatitis B vaccine (360 ELISA Units inactivated HAV + 10 micrograms recombinant hepatitis B surface antigen), indicated for children/adolescents aged 1 up to and including 15 years — it is NOT a standalone adult monovalent hepatitis B vaccine. No adult monovalent dosing is available in this bundle; clinician to source the specific hepatitis B vaccine product SPC for adult/monovalent regimens. Standard primary course = two doses; once initiated, complete with the same vaccine. If rapid protection against hepatitis B is required, the standard three-dose regimen of the combined vaccine (360 ELISA Units HAV + 10 micrograms HBsAg) is recommended instead. Booster: need in healthy fully-vaccinated individuals not established; maintain protective antibody level >= 10 mIU/ml in at-risk groups (e.g. haemodialysis, immunocompromised). Not recommended for post-exposure prophylaxis (e.g. needle-stick). Exceptionally may be given subcutaneously in thrombocytopenia/bleeding disorders (may give suboptimal response); must never be given intravascularly or into the gluteal muscle. Paediatric: safety and efficacy in children aged less than 1 year not established.

Dose auto-extracted from UK Summary of Product Characteristics (SPC) via the eMC — not yet clinician-verified. Always confirm against the product SmPC and your local formulary before prescribing.

Contraindications

Hypersensitivity to the active substances or to any of the excipients, or to neomycin
Hypersensitivity after previous administration of hepatitis A and/or hepatitis B vaccines
Administration should be postponed in subjects suffering from acute severe febrile illness

Side effects

Pain and fatigue (most common; approx. 50% and 30% per dose)
Redness at the injection site; loss of appetite; irritability; headache (very common)
Drowsiness; gastrointestinal symptoms; fever; swelling at the injection site (common)
Dizziness, myalgia, upper respiratory tract infection (uncommon)
Allergic reactions including anaphylactic/anaphylactoid reactions; syncope/vasovagal responses (post-marketing)

Clinical monograph

How it works

It contains recombinant hepatitis B surface antigen which stimulates production of protective anti-HBs antibodies and immunological memory against the virus.

Prescribing in practice

It is contraindicated in those with a confirmed anaphylactic reaction to a previous dose or a vaccine component, and the full course is required for reliable protection.
Some at-risk and immunocompromised individuals need post-vaccination antibody testing and may require reinforcing or higher-antigen schedules.
Administer intramuscularly and follow the relevant Green Book chapter, the SPC and current prescribing references for schedules and combination vaccines.

Monitoring

Post-vaccination anti-HBs testing is recommended for selected groups such as healthcare workers and renal patients to confirm an adequate response.

Counselling the patient

Complete every dose in the schedule, as partial courses may not give protection.
Some people, such as healthcare workers, need a blood test afterwards to check the response.
Injection-site soreness and mild tiredness are common and usually short-lived.

Evidence & guidelines

Hepatitis B vaccination schedules and the use of post-vaccination antibody testing for at-risk groups are set out in the UK immunisation guidance (the Green Book).

Reference: UK Green Book; Drug verified in RxNorm (NLM); confirm dosing against the manufacturer SPC (eMC). Verify against your local formulary and current prescribing references before prescribing. The structured dose values shown have been reviewed by a clinician. Monograph status: clinician-reviewed (2026-07-04).

Curated clinical cross-links plus same-class fallbacks.

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