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 hepatitis B surface antigen vaccine whose active ingredients include aluminium adjuvant and recombinant hepatitis B surface antigen produced in *Saccharomyces cerevisiae* cells. The product is supplied as an injectable preparation for intramuscular or subcutaneous use; specific strength and dosage form are not disclosed in the available data. It is marketed within the European Union, clinically and widely, for the prevention 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 individuals who have not been previously vaccinated.

  • Primary prevention in infants, children, and adults.
  • Post‑exposure prophylaxis for persons with recent exposure to hepatitis B.
  • Use in healthcare workers at risk of occupational exposure.
  • Administration as part of a three‑dose series (0, 1, and 6 months) according to local guidelines.
  • May be given to individuals with chronic liver disease to reduce risk of superinfection.

Side Effects

The safety profile of Hbvaxpro reflects typical reactions observed with recombinant hepatitis B vaccines.

Common

  • Pain, redness, or swelling at the injection site, typically resolving within a few days.
  • Low‑grade fever, usually transient and self‑limited.
  • Fatigue or mild malaise lasting 24–48 hours.

Serious

  • Severe allergic reaction (anaphylaxis), characterized by difficulty breathing, hives, or swelling of the face and throat.
  • Guillain‑Barré syndrome, a rare autoimmune neuropathy presenting with muscle weakness.
  • Persistent high fever or neurological symptoms such as weakness, numbness, or seizures, requiring immediate medical attention.

Precautions & Warnings

Before administering Hbvaxpro, healthcare providers should review the patient’s medical history and consider specific precautionary measures.

  • Known hypersensitivity to any vaccine component, especially aluminium salts, should contraindicate use.
  • History of severe allergic reaction to a previous hepatitis B vaccine dose requires evaluation.
  • Moderate or severe acute illness with fever may warrant postponement of vaccination.
  • Pregnancy and lactation status should be assessed; vaccination may be given if benefits outweigh risks.
  • Immunocompromised individuals may have a reduced immune response and should follow recommended dosing schedules.
  • Use caution in patients with chronic kidney disease due to aluminium exposure.

Avoid Interactions

Hbvaxpro does not have many documented drug‑drug interactions, but certain agents may influence vaccine response or safety.

Avoid

  • Concurrent administration of other live vaccines at the same anatomical site.
  • Use of systemic corticosteroids or immunosuppressive therapy at high doses during the vaccination period.

Use with caution

  • Antiviral therapy for hepatitis B infection; timing may be coordinated with the provider.
  • Blood products or immunoglobulins given within 4 weeks before or after vaccination may reduce immunogenicity.
  • Chronic alcohol use or heavy smoking, which can impair immune response.

Frequently Asked Questions

Hbvaxpro is typically given as a three‑dose series at month 0, month 1, and month 6, following standard hepatitis B vaccination guidelines.

Yes, the vaccine may be administered by either the intramuscular or subcutaneous route, as directed by the healthcare professional.

Hbvaxpro is approved for primary prevention of hepatitis B in newborns, infants, children, and adults who have not been previously vaccinated.

Mild pain is common and usually resolves on its own; however, if pain is severe, persistent, or accompanied by swelling, the patient should contact a healthcare provider.

The vaccine should be stored according to the manufacturer’s instructions, typically in a refrigerator between 2 °C and 8 °C, and protected from freezing.

Yes, vaccination is recommended for people with chronic liver disease to reduce the risk of hepatitis B superinfection.

Vaccination may be considered during pregnancy if the potential benefits outweigh any theoretical risks; the decision should be made by a qualified healthcare professional.

Signs include difficulty breathing, swelling of the face or throat, hives, rapid heartbeat, or dizziness, and require immediate medical attention.

Testing for anti‑HBs antibodies can be performed to confirm seroconversion, especially in high‑risk groups or immunocompromised patients.

Hbvaxpro can be co‑administered with other non‑live vaccines at different injection sites, but live vaccines should be given at separate times or sites.

The missed dose should be administered as soon as possible, and the remaining doses should follow the standard schedule to complete the series.

Individuals with documented prior infection or immunity may not require vaccination; serologic testing can determine the need for immunization.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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