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Heplisav B

Active Ingredient:
Hepatitis B Surface Antigen, Cpg 1018
Origin:
EU

Heplisav B (Hepatitis B Surface Antigen, Cpg 1018)

Heplisav B is a hepatitis B vaccine that contains 20 µg of recombinant hepatitis B surface antigen combined with the CpG 1018 adjuvant. It is supplied as a sterile injectable solution for intramuscular use and is prescribed in the European Union for adult immunization against hepatitis B virus infection. The product is administered by a healthcare professional and is classified as a prescription‑only medicine. It is stored in a refrigerator.

Manufacturer / TM Owner

Dynavax Gmbh

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Indications & Clinical Uses

Heplisav B is indicated for the prevention of hepatitis B infection in adults who have not been previously immunized or who require booster protection.

  • Primary immunization series for hepatitis B‑naïve adults.
  • Booster vaccination for adults with documented prior hepatitis B vaccination when antibody levels have declined.
  • Use in individuals at increased risk of exposure, such as healthcare workers, travelers to endemic regions, or patients with chronic liver disease.
  • Administration as part of a two‑dose schedule spaced one month apart, as recommended by health authorities.

Side Effects

The safety profile of Heplisav B includes both common, generally mild reactions and rare, more serious events.

Common

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

Serious

  • Severe allergic reaction (anaphylaxis) with symptoms such as difficulty breathing, hives, or swelling of the face.
  • Guillain‑Barré syndrome, a rare neurological disorder.
  • Thrombocytopenia or other blood‑cell abnormalities.

Precautions & Warnings

Healthcare providers should assess individual health status before administering Heplisav B and observe standard vaccination precautions.

  • Do not administer to persons with known severe allergy to any vaccine component, including CpG 1018.
  • Postpone vaccination in individuals with moderate or severe acute illness until recovery.
  • Evaluate immune status in patients with immunosuppressive conditions; vaccine may be less effective.
  • Counsel pregnant or breastfeeding women that the vaccine is classified as pregnancy category B and is considered safe, but discuss benefits versus risks.
  • Monitor for signs of anaphylaxis for at least 15 minutes after injection.
  • Document previous hepatitis B vaccination history to determine need for booster dosing.

Avoid Interactions

Heplisav B does not have direct pharmacologic interactions, but certain conditions and therapies may influence its administration.

Avoid

  • Concurrent administration of other live vaccines; separate by at least 4 weeks.
  • Use in individuals receiving high‑dose immunoglobulin therapy within 3 months, as it may reduce vaccine efficacy.

Use with caution

  • Patients on immunosuppressive drugs or chemotherapy; immune response may be diminished.
  • Individuals with chronic kidney disease undergoing dialysis; monitor antibody response.
  • Concurrent use of antipyretics may mask mild fever post‑vaccination but does not affect immunity.

Frequently Asked Questions

Heplisav B contains recombinant hepatitis B surface antigen (HBsAg) at a strength of 20 µg per 0.5 mL, combined with the CpG 1018 adjuvant.

Heplisav B is given as an intramuscular injection, typically in the deltoid muscle, by a qualified healthcare professional.

The vaccine is administered as a two‑dose series, with the second dose given one month after the first dose.

Yes, Heplisav B can be used as a booster in adults who have completed a prior hepatitis B vaccination series and whose antibody levels have declined.

Heplisav B is classified as pregnancy category B, indicating that animal studies have not shown risk and there are no well‑controlled studies in pregnant women; it may be used when the benefits outweigh potential risks.

Common reactions include pain, redness, or swelling at the injection site, low‑grade fever, fatigue, headache, and mild nausea.

Rare serious events include anaphylaxis, Guillain‑Barré syndrome, and blood‑cell abnormalities such as thrombocytopenia.

People with immunosuppressive conditions may receive Heplisav B, but the immune response may be reduced; clinicians should assess the need for additional monitoring.

Heplisav B should not be given concurrently with live vaccines; a minimum interval of four weeks is recommended between them.

The vaccine must be stored in a refrigerator between 2 °C and 8 °C (36 °F–46 °F) and should not be frozen.

There are no specific medication restrictions, but antipyretics taken before vaccination may mask mild fever; they can be used after vaccination if needed.

Heplisav B uses the CpG 1018 adjuvant, which activates Toll‑like receptor 9 to enhance both humoral and cellular immunity, allowing a shorter two‑dose schedule compared with some other hepatitis B vaccines.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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