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[4].

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

Dosage and Administration

The infant should receive a single 110 IU neonatal dose of HyperHEP B at birth. The dose is preferably given within 12 hours of birth as efficacy decreases markedly if treatment is delayed beyond 48 hours. 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.