Europe — EMA
Heplisav B
Heplisav B is an EU‑approved hepatitis B surface antigen vaccine with CpG 1018 adjuvant, used for preventing hepatitis B infection.
Request sourcing
What is 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.
What is Hepatitis B Surface Antigen, Cpg 1018 used for?
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
What are the side effects of Hepatitis B Surface Antigen, Cpg 1018?
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
What precautions apply to Hepatitis B Surface Antigen, Cpg 1018?
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
What does Hepatitis B Surface Antigen, Cpg 1018 interact with?
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
What is the active ingredient in Heplisav B?+
How does the CpG 1018 adjuvant work in Heplisav B?+
What is the recommended route of administration for Heplisav B?+
Who should receive Heplisav B vaccination?+
Can Heplisav B be given to pregnant women?+
What are the common side effects after Heplisav B injection?+
What serious adverse events have been reported with Heplisav B?+
Should Heplisav B be given to immunocompromised patients?+
Is there any need to avoid other vaccines when receiving Heplisav B?+
How many doses of Heplisav B are required for full protection?+
Can antipyretics be taken before receiving Heplisav B?+
What should be done if an allergic reaction occurs after Heplisav B?+
Product details
Related products

A
Liquid Extract From Viscum Album Subsp. Abietis Var Abies Alba (1:20), Extraction Solvents: Water Fo

A
Liquid Extract From Viscum Album Subsp. Abietis Var Abies Alba (1:20), Extraction Solvents: Water Fo

A
Liquid Extract From Viscum Album Subsp. Abietis Var Abies Alba (1:20), Extraction Solvents: Water Fo

A
Liquid Extract From Viscum Album Subsp. Abietis Var Abies Alba (1:20), Extraction Solvents: Water Fo