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HepaGam B™ is the first Intravenous Hepatitis B Immune Globulin licensed by the FDA for the prevention of Hepatitis B recurrence following liver transplantation in HBsAg-positive liver transplant patients.

HepaGam B™ is also FDA licensed for treatment of acute exposure to hepatitis B infection.  

• Treatment of acute exposure to blood containing HbsAg
• Perinatal exposure of infants born to HbsAg-positive mothers
• Sexual exposure to HbsAg-positive persons
• Household exposure to persons with acute HBV infection
• Household exposure of infants less than 12 months old whose mother or primary care giver is positive for HBsAG

HepaGam B™ is also licensed in Canada for the prevention of Hepatitis B recurrence following liver transplantation in adult patients with Hepatitis B as found under Health Canada’s Notice of Compliance with Conditions (NOC/c) policy.

Licensure in Canada of HepaGam B™ marks approval of the only Hepatitis B Immune Globulin (HBIG) product labeled for intravenous administration to prevent recurrence of Hepatitis B following liver transplantation.

HepaGam B™ is a sterile solution of purified gamma globulin (IgG) fraction of human plasma containing antibodies to hepatitis B surface antigen (anti-HBs).  HepaGam B™ is manufactured from plasma collected from healthy, screened donors with high titres of anti-HBs, which is purified by an anion-exchange column chromatography method.