Product image of Hbvaxpro (Aluminium, Hepatitis B Surface Antigen (Rdna) [produced In S. Cerevisiae Cells By Rdna]) supplied by GNH India

Hbvaxpro

Active Ingredient:
Aluminium, Hepatitis B Surface Antigen (Rdna) [produced In S. Cerevisiae Cells By Rdna]
Origin:
EU

Hbvaxpro (Aluminium, Hepatitis B Surface Antigen (Rdna) [produced In S. Cerevisiae Cells By Rdna])

Hbvaxpro is a recombinant hepatitis B surface antigen vaccine that contains aluminium as an adjuvant and hepatitis B surface antigen produced by rDNA technology in Saccharomyces cerevisiae cells. It is supplied as an injectable solution for intramuscular or subcutaneous administration. The product is marketed in the European Union and is available by prescription only and is intended for use in individuals at risk of hepatitis B infection.

Manufacturer / TM Owner

Merck Sharp & Dohme B.V.

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Indications & Clinical Uses

Hbvaxpro is indicated for the active immunization against hepatitis B virus infection in persons who have not been previously vaccinated or who require a booster dose.

  • Primary prevention of hepatitis B infection in infants, children, and adults.
  • Post‑exposure prophylaxis for individuals with recent exposure to hepatitis B virus.
  • Booster vaccination for persons with waning anti‑HBs antibody levels.
  • Immunization of healthcare workers and others at occupational risk.
  • Use in travel medicine for persons traveling to regions with high hepatitis B prevalence.

Side Effects

The safety profile of Hbvaxpro reflects that of other recombinant hepatitis B vaccines; most reactions are mild and transient.

Common

  • Pain, redness, or swelling at the injection site.
  • Low‑grade fever.
  • Fatigue or mild headache.
  • Nausea.

Serious

  • Severe allergic reaction (anaphylaxis) with difficulty breathing or swelling of the face.
  • Neurological events such as Guillain‑Barré syndrome, though rare.
  • Persistent high fever or seizures.

Precautions & Warnings

Before administering Hbvaxpro, healthcare providers should evaluate patient history and current health status to minimize risk of adverse events.

  • Do not vaccinate individuals with a known severe allergy to any vaccine component, including aluminium salts.
  • Defer vaccination in persons experiencing moderate or severe acute illness until recovery.
  • Use caution in patients with a history of hypersensitivity to yeast proteins.
  • Monitor for signs of anaphylaxis for at least 15 minutes after injection.
  • Discuss the benefits and risks of vaccination with pregnant or lactating women, as safety data are limited.
  • Consider serologic testing to assess immunity in individuals with uncertain vaccination status.

Avoid Interactions

Hbvaxpro does not have many documented drug‑drug interactions, but certain concomitant therapies may influence immune response or increase adverse‑event risk.

Avoid

  • Simultaneous administration of other live vaccines (e.g., measles, mumps, rubella) in the same injection site.
  • Use of systemic corticosteroids or immunosuppressive agents at high doses during the vaccination series.

Use with caution

  • Moderate immunosuppression (e.g., low‑dose steroids, chemotherapy) may reduce antibody response.
  • Antipyretics such as acetaminophen or ibuprofen can be taken to manage mild post‑vaccination fever.
  • Patients receiving blood products or immunoglobulins should have vaccination timing coordinated to avoid interference with antibody development.

Frequently Asked Questions

Hbvaxpro contains recombinant hepatitis B surface antigen produced in yeast; when injected, the antigen is presented to the immune system, prompting B‑cells to produce anti‑HBs antibodies that confer protection against hepatitis B virus infection.

The vaccine is recommended for individuals who have not been previously immunized against hepatitis B, for those at occupational risk, for travelers to endemic areas, and for persons needing a booster dose due to waning immunity.

Yes, Hbvaxpro is approved for primary immunization of infants and children as part of the standard hepatitis B vaccination schedule, following the dosing intervals recommended by health authorities.

Safety data in pregnancy are limited; the vaccine may be administered when the potential benefit outweighs any theoretical risk, and the decision should be made in consultation with a healthcare professional.

Common reactions include mild pain, redness, or swelling at the injection site, low‑grade fever, fatigue, headache, and occasional nausea, typically resolving within a few days.

Rare serious events include anaphylaxis, Guillain‑Barré syndrome, and persistent high fever or seizures; immediate medical attention is required if these occur.

Live vaccines should not be given at the same injection site on the same day; non‑live vaccines may be administered concurrently but spacing is often recommended to assess individual reactions.

Patients receiving high‑dose corticosteroids or other strong immunosuppressants may have a reduced antibody response and may require additional doses or serologic testing to confirm immunity.

Hbvaxpro is administered as an injectable solution via the intramuscular or subcutaneous route, typically in the deltoid muscle for adults and the anterolateral thigh for infants.

A booster dose may be recommended for individuals with documented low anti‑HBs antibody levels or for those at continued high risk of exposure, based on serologic testing.

Yes, over‑the‑counter antipyretics such as acetaminophen or ibuprofen may be taken to relieve mild fever or discomfort after vaccination.

Hbvaxpro is classified under ATC code J07BC01, which corresponds to hepatitis B vaccines.

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GNH India Pharmaceuticals Limited

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Last updated:

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