HEPAGAM B®

Hepatitis B Immune Globulin Intravenous (Human) [Standardized amount of HBV antibody]

Presentation:

1 mL or 5 mL single-dose vial (>312IU/mL)

Therapeutic Indication:

Post-exposure Prophylaxis

HepaGam B is indicated for the treatment of acute exposure to blood containing hepatitis B surface antigen (HBsAg), perinatal exposure of infants born to HBsAg-positive mothers, sexual exposure to HBsAg-positive persons and household exposure to persons with acute HBV infection in the following settings:

• Acute Exposure to Blood Containing HBsAg – Following either parenteral exposure (needlestick, bite, sharps), direct mucous membrane contact (accidental splash), or oral ingestion (pipetting accident) involving HBsAg-positive materials such as blood, plasma, or serum.
• Perinatal Exposure of Infants Born to HBsAg-positive Mothers – Infants born to mothers positive for HBsAg with or without Hepatitis B e antigen (HBeAg).
• Sexual Exposure to HBsAg-positive Persons – Sexual partners of HBsAg-positive persons.
• Household Exposure to Persons with Acute HBV Infection – Infants less than 12 months old whose mother or primary caregiver is positive for HBsAg, or other household contacts with identifiable blood exposure to the index patient.
• HepaGam B is administered intramuscularly for post-exposure prophylaxis.

Prevention of Hepatitis B Recurrence Following Liver Transplantation (NOC/c)

HepaGam B is indicated for the prevention of hepatitis B recurrence following liver transplantation in adult patients with hepatitis B who have no or low levels of HBV replication. The efficacy of HepaGam B in conjunction with antivirals such as lamivudine will be assessed in a Phase III confirmatory study. HepaGam B should be administered intravenously for this indication.