Transfusion medicine handbook

5. Fractionated Products

5.4.3 HyperHEP B

HyperHEP B is a sterile, preservative-free, solvent/detergent-treated solution containing not less than 220 IU/mL neutralising hepatitis B antibodies. Donations used in the preparation of HyperHEP B are selected on the basis that they contain high levels of specific antibodies against HBsAg. HyperHEP B is supplied as a 0.5 mL neonatal single-dose syringe containing at least 110 IU of hepatitis B immunoglobulin, intended for intramuscular injection [7]. From June 2026, a 5 mL vial will also be available because of a temporary shortage of Hepatitis B Immunoglobulin-VF. The 5 mL vial is intended for use in adults.

Indications for Use

HyperHEP B is indicated for:

•      Infants born to HBsAg-positive mothers, either chronic carriers or those who contract hepatitis B during pregnancy
•      Acute exposure to blood containing HBsAg
•      Sexual exposure to an HBsAg-positive person
•      Household exposure to persons with acute HBV infection [7].

Dosage and Administration

Infants should receive a single 110 IU neonatal dose of HyperHEP B at birth (0.5 mL). The dose is preferably given within 12 hours of birth. Hepatitis B vaccine should be administered concurrently with hepatitis B immunoglobulin (or at most within 7 days) but at a separate site. If administration of the first dose of hepatitis B vaccine is delayed for as long as 3 months, then a 0.5 mL dose of HyperHEP B should be repeated at 3 months. If vaccine is refused, the 0.5 mL dose of HyperHEP B should be repeated at 3 and 6 months [7].

Acute exposure to blood containing HBsAg. The datasheet provides more information about management of unvaccinated vs vaccinated people who have been exposed. If HyperHEP B is needed then the dose is 0.06 mL/kg body weight administered intramuscularly [7].

Sexual exposure to an HBsAg-positive person. All susceptible persons, whose sex partners have acute hepatitis B infection, should receive a single dose of HyperHEP B (0.06 mL/kg) and initiate Hepatitis B Vaccine series. The immunoglobulin dose should be within 14 days of the last sexual contact [7].

Household exposure to persons with acute HBV infection. Prophylactic treatment with a 0.5 mL dose of HyperHEP B and hepatitis B vaccine is indicated for infants < 12 months of age, who have been exposed to a primary care-giver who has acute hepatitis B. Prophylaxis for other household contacts of persons with acute HBV infection is not indicated unless they have had identifiable blood exposure to the index patient, such as by sharing toothbrushes or razors [7].

Observe the recipient for 20 minutes after administration.