Heplisav B

Heplisav B is a recombinant hepatitis B surface antigen vaccine that contains hepatitis B surface antigen and the CpG 1018 adjuvant. It is supplied as an injectable solution for intramuscular administration. The product is marketed in the European Union and is prescribed (Rx) for active immunization against hepatitis B virus. Strength details are not specified in the publicly available labeling, currently official and in the EU.

Heplisav B is indicated for the prevention of hepatitis B infection in specific populations.

- Adults 18 years and older who have not been previously vaccinated against hepatitis B. - Adolescents 12–17 years of age who are at risk for hepatitis B exposure. - Individuals with occupational exposure risk, such as health‑care workers. - Persons with chronic liver disease, diabetes, or other conditions that increase susceptibility to hepatitis B. - Travelers to regions where hepatitis B is endemic.

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

Common: - Pain, redness, or swelling at the injection site. - Low‑grade fever. - Headache or fatigue. - Mild muscle aches. - Nausea. - Mild joint pain. - Transient rash.

Serious: - Severe allergic reaction (anaphylaxis). - Guillain‑Barré syndrome (rare). - High fever with chills. - Neurological symptoms such as weakness or numbness. - Severe injection site reaction (e.g., necrosis). - Thrombocytopenia.

Before administering Heplisav B, healthcare providers should consider several precautionary factors to ensure safe use.

- Known hypersensitivity to any component of the vaccine, including the CpG 1018 adjuvant. - History of severe allergic reaction to a previous hepatitis B vaccine. - Immunocompromised patients, as response may be reduced. - Pregnancy and breastfeeding status, because safety data are limited. - Acute moderate or severe illness at the time of vaccination. - Use in individuals younger than 12 years, which is not approved.

Heplisav B may interact with other agents; certain combinations should be avoided while others require careful monitoring.

Avoid: - Concurrent administration of other live vaccines (e.g., measles, mumps, rubella). - Simultaneous use of immunosuppressive biologics that could blunt vaccine response. - High‑dose chemotherapy administered within 2 weeks of vaccination.

Use with caution: - Antiviral therapy for chronic hepatitis B, as it may affect serologic testing. - Systemic corticosteroids, which may reduce immunogenicity. - Blood products or immunoglobulins given within 4 weeks of vaccination. - Patients receiving interferon therapy. - Interferon therapy may alter immune response to the vaccine.