Browse HepaGam B HepaGam B Home Patients and Families Healthcare Professionals Plasma Safety Common Questions HepaGam B Canadian Product Monograph and Canadian Package Insert

HepaGam B is a hyperimmune product that is manufactured from human plasma (derived from human blood). HepaGam B is a liquid product that is administered intravenously.

Hepatitis B is the most common and serious liver infection worldwide and is caused by the hepatitis B virus (HBV), which attacks the liver. The virus is transmitted through blood and infected bodily fluids that are Hepatitis B Surface Antigen Positive (HBsAg +). Transmission of HBV can occur through direct blood-to-blood contact, unprotected sex, use of non-sterile needles and from an infected women to her newborn during the delivery process.

Approximately 90% of healthy adults infected with hepatitis B will naturally recover and develop protective antibodies against future hepatitis B infections. Unfortunately, this is not true for infants and young children, where 90% of infants and up to 50% of young children infected with hepatitis B will develop chronic infections. An estimated 5-10% will not recover from the virus and develop chronic infections and are at risk for the development of end stage liver disease such as cirrhosis and liver cancer, conditions that necessitate liver transplantation.

An estimated 2 billion people worldwide are infected with HBV. Approximately 400 million people are chronically infected and each year an additional 10-30 million people will become infected. 1 million people worldwide die each year from hepatitis B and its complications.

Chronic hepatitis B can lead to cirrhosis of the liver, liver cancer and even death. An estimated 25% of the people infected with chronic hepatitis B are expected to develop progressive liver disease. Hepatitis B is 50-100 times more contagious than HIV. Chronic hepatitis B is the sixth leading cause of liver transplantation.

Reference:
http://www.cdc.gov/ncidod/aip/research/hepatitis/hep_b.html#what_hepb

HepaGam B protects the newly transplanted liver from re-infection with the hepatitis B virus (HBV). For HepaGam B to be effective in preventing hepatitis B recurrence, treatment should begin during the liver transplantation and continued regularly after transplant. Laboratory tests will determine if HepaGam B is working, by measuring levels of HepaGam B in serum (the liquid portion of blood) and by looking for signs/symptoms of hepatitis B infection.

Patients should talk to their doctor or pharmacist before using HepaGam B if:

• They have experienced allergic reactions to blood products in the past
• They have a known IgA deficiency
• They are pregnant or nursing
• They use any device to measure blood glucose

While being treated with HepaGam B, regular blood tests will be conducted to check for adequate drug levels.

Medicinal ingredients:
Hepatitis B Immune Globulin (Human)

Important nonmedicinal ingredients:
Human plasma protein
Sodium Chloride
Polysorbate 80

HepaGam B may contain trace amounts of tri-n-butyl phosphate and Triton X-100^®.

Dosage forms:
HepaGam B is a sterile liquid supplied in 1 mL and 5 mL vials. Each vial contains > 312 IU (International Units) of the active ingredient (Hepatitis B Immune Globulin).

Administration:
HepaGam B is administered intravenously.

Dosage:
Each dose of 35 ML (10,920 international units) is given by an intravenous injection that may take approximately 20 minutes.

Typical dosing schedule:

• First dose during the liver transplantation operation
• Daily dose for the first week post-operative
• Once every two weeks for the first three months post-operative
• Once a month thereafter

* If a schedule dose is missed, it should be given as soon as possible after the missed dose. Your doctor will adjust your dosing schedule if required.

The most common side effects are chills, fever, headaches, vomiting, allergic reactions, nausea and arthralgia (joint pain). * These side effects are usually mild, but if they require treatment consult with your health care professional.

Hepatitis B recurrence can occur after liver transplantation in patients who are hepatitis B surface antigen (HBsAg) positive at the time of transplant. Recurrence results from the infection of the liver graft with hepatitis B virus (HBV) remaining in circulation and/or coming from extrahepatic sites.

Cangene utilizes its world class manufacturing process that features a two-step viral removal process including a solvent detergent step and a Planova 20 nm virus filter, which effectively removes lipid-enveloped and non-enveloped viruses based on size, and a solvent/detergent treatment step that effectively inactivates lipid-enveloped viruses. These two processes are designed to increase product safety by reducing the risk of viral transmission of several viruses including human immunodeficiency virus (HIV), hepatitis B and hepatitis C. However, despite these measures, such products can still potentially transmit disease. There is also the possibility that unknown infectious agents may be present in such products.

An NOC/c is a form a marketing approval granted to a product on the basis that there is promising clinical evidence for the intended indications (usage). The product sponsor is required to carry out additional clinical trials to verify the anticipated benefits (within an agreed upon time frame with Health Canada).

The NOC/c policy was established to make certain products available for the treatment; prevention or diagnosis of a serious unmet medical need, life threatening or severely debilitating illness. These products have demonstrated promising benefit, are of high quality and possess an acceptable safety profile based on benefit/risk assessment.

Canadian Association for the Study of the Liver
www.hepatology.ca

Canadian Liver Foundation
www.liver.ca

Canadian Society of Transplantation
www.cst-transplant.ca

Canadian Association of Hepatology Liver Nurses
www.livernurses.org

HepNet – Hepatitis B Awareness
www.hepnet.com

Hepatitis B Foundation
www.hepb.org