Product image of Heplisav B (Hepatitis B Surface Antigen, Cpg 1018) supplied by GNH India

Heplisav B

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

Heplisav B (Hepatitis B Surface Antigen, Cpg 1018)

Heplisav B is a recombinant hepatitis B surface antigen vaccine combined with the CpG 1018 adjuvant, supplied as an injectable vaccine for intramuscular use. The product is authorized in the European Union and is prescribed by healthcare professionals. Strength information is not disclosed in the public labeling, and the vaccine is intended to stimulate protective immunity against hepatitis B virus infection.

Manufacturer / TM Owner

Dynavax Gmbh

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Indications & Clinical Uses

Heplisav B is indicated for the prevention of hepatitis B infection in individuals who have not been previously immunized or who require booster protection. It is administered as a series of intramuscular injections according to recommended schedules.

  • Adults and adolescents at risk of hepatitis B exposure
  • Healthcare workers with potential occupational exposure
  • Individuals with chronic liver disease
  • Travelers to regions with high hepatitis B prevalence
  • Persons with diabetes mellitus requiring vaccination

Side Effects

Heplisav B may cause a range of post‑vaccination reactions, most of which are mild and resolve without medical intervention. Serious adverse events are rare but should be monitored.

Common

  • Injection‑site pain, redness, or swelling
  • Low‑grade fever within 24‑48 hours
  • Fatigue or mild headache
  • Muscle aches at the injection site
  • Transient nausea or gastrointestinal discomfort

Serious

  • Severe allergic reaction (anaphylaxis) with difficulty breathing
  • High fever persisting more than 48 hours
  • Neurological symptoms such as seizures or altered consciousness
  • Persistent joint inflammation (arthralgia) lasting several days
  • Unexplained rash covering large body areas

Precautions & Warnings

Healthcare providers should assess individual risk factors before administering Heplisav B and observe patients for immediate reactions. Specific considerations include:

  • Known hypersensitivity to any vaccine component, especially CpG 1018 adjuvant
  • History of severe allergic reactions to previous hepatitis B vaccines
  • Pregnancy status is unknown; vaccinate only if benefits outweigh potential risks
  • Immunocompromised patients may have reduced vaccine efficacy
  • Patients with acute moderate or severe illness should defer vaccination until recovery
  • Monitor for signs of anaphylaxis for at least 15 minutes post‑injection

Avoid Interactions

Heplisav B does not have documented pharmacokinetic interactions, but certain conditions may influence its safety or effectiveness.

Avoid

  • Concurrent administration of live vaccines within 4 weeks of Heplisav B
  • Use of immunosuppressive therapy that may blunt immune response

Use with caution

  • Antipyretics or analgesics taken prophylactically before injection
  • Patients receiving other adjuvanted vaccines within a short interval
  • Individuals with uncontrolled autoimmune disorders
  • Concurrent administration with blood products that may affect antigen presentation

Frequently Asked Questions

Heplisav B contains recombinant hepatitis B surface antigen combined with the CpG 1018 adjuvant to enhance immune response.

CpG 1018 activates Toll‑like receptor 9 (TLR9), stimulating both humoral and cellular immunity for a stronger protective effect.

Heplisav B is administered by intramuscular injection, typically into the deltoid muscle.

The vaccine is indicated for individuals at risk of hepatitis B infection, including adults, adolescents, healthcare workers, travelers to endemic areas, and persons with chronic liver disease.

Pregnancy safety data are limited; vaccination should be considered only if the potential benefit justifies any potential risk to the fetus.

Common reactions include injection‑site pain, redness, low‑grade fever, fatigue, muscle aches, and mild nausea.

Serious events are rare but may include anaphylaxis, high fever lasting more than 48 hours, neurological symptoms, persistent joint inflammation, and extensive rash.

Immunocompromised individuals can receive the vaccine, but the immune response may be reduced; timing with immunosuppressive therapy should be considered.

Live vaccines should be avoided within four weeks before or after Heplisav B to prevent potential interference.

Heplisav B is typically given as a two‑dose series, with the second dose administered one month after the first.

Prophylactic use of antipyretics before vaccination is not recommended; they may be used after injection if needed for symptom relief.

If signs of an allergic reaction appear, such as difficulty breathing or swelling, seek immediate medical attention and report the event to a healthcare professional.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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