Heplisav B

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.

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.

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.

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.

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.