Transfusion medicine handbook

5. Fractionated Products

5.4.2 HEPATITIS B IMMUNOGLOBULIN-VF

Hepatitis B Immunoglobulin-VF is a sterile, preservative-free solution containing not less than 100 IU/mL neutralising hepatitis B antibodies. Donations used in the preparation of Hepatitis B Immunoglobulin-VF are selected on the basis that they contain high levels of specific antibodies against HBsAg. Hepatitis B Immunoglobulin-VF is provided as 400 IU vials, intended for intramuscular injection.

Indications for Use

Hepatitis B Immunoglobulin-VF is indicated for [5]:

• Post-exposure prophylaxis in persons who did not receive prior vaccination or whose vaccination regimen is incomplete, or when the hepatitis B antibody level is inadequate (< 10 IU/L)
• Post-exposure prophylaxis should be considered following percutaneous or permucosal exposure to the hepatitis B virus surface antigen (HBsAg)-positive or suspected HBsAg-positive material, for example, by needle stick, oral ingestion or sexual exposure.
• Infants born to HBsAg-positive mothers, either chronic carriers or those who contract hepatitis B during pregnancy
• Patients with hepatitis B undergoing a liver transplant, to protect the transplanted liver

Dosage and Administration

For maximum protective effect, Hepatitis B Immunoglobulin-VF should be given within 72 hours of exposure. Efficacy is greatly reduced if it is given after a longer interval.

Table 5.15: Prophylaxis with Hepatitis B Immunoglobulin-VF in Adults Following Percutaneous or Permucosal Exposure to HBsAg-positive or Suspected HBsAg-positive Material [5]

Active immunisation with hepatitis B vaccine should always be commenced in conjunction with administration of Hepatitis B Immunoglobulin-VF in patients exposed to hepatitis B virus. Vaccination should be initiated simultaneously with the passive immunoglobulin but administered at a different site.

Prophylaxis in Infants Born to HBsAg-positive Mothers

Where HyperHEP B is unavailable, give 100 IU Hepatitis B Immunoglobulin-VF to the infant at birth and initiate simultaneously a hepatitis B vaccination regime administered at a different site.