Fact sheet - HepaGam B™ (Hepatitis B Immune Globulin [Human] Injection)

2007-01-19

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What is HepaGam B™?

HepaGam B™ (Hepatitis B Immune Globulin [Human] Injection), is a sterile solution of purified gamma globulin (IgG) fraction of human plasma containing antibodies to hepatitis B surface antigen (anti-HBs).

HepaGam B™, indicated for the prevention of hepatitis B recurrence following liver transplantation, has been approved by Health Canada under the Notice of Compliance with Conditions (NOC/c) policy. This authorization reflects the promising nature of the clinical evidence, which must be verified with further data. Products approved under Health Canada's NOC/c policy, have demonstrated promising benefit, are of high quality and possess an acceptable safety profile based on a benefit/risk assessment.

What is HepaGam B™ used for?

HepaGam B™ is used in the prevention of hepatitis B recurrence following liver transplantation in adult patients with hepatitis B who have no or low levels of HBV replication.

What is Hepatitis B recurrence?

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.

How does HepaGam B™ work?

The mechanism whereby hepatitis B immune globulin (HBIG) protects the transplanted liver against HBV infection is not well defined. HBIG may block HBV binding to liver cells, neutralize circulating HBV, target infected cells through an antibody-mediated immune response and/or interact with HBsAg within cells.

Regardless of the mechanism, there is evidence of a dose-dependent response to HBIG treatment.

For HepaGam B™ to be effective in preventing hepatitis B recurrence, treatment should be started during 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 of hepatitis B infection.

What other treatments have been used to prevent Hepatitis B recurrence?

There are currently no other products licensed to prevent Hepatitis B recurrence following liver transplantation, although antiviral therapy has been used to prevent the recurrence in some patients.

What do patients need to know about using HepaGam B™?

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
• If 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.

Drugs that may interact with HepaGam B™ have not been established.

Immune globulins like HepaGam B™ may impair the effectiveness of certain live virus vaccines such as measles, rubella (German measles), mumps and varicella (chicken pox). Patients should talk to their doctor if they have been recently vaccinated or require vaccination.

What are the side effects and how serious are they?

The most common side effects are chills, fever, headaches, vomiting, allergic reactions, nausea, arthralgia (pain in joints) and moderate low back pain. These side effects are usually mild, but if they require treatment patients should ask their health care professional.

Certain side effects may be related to the rate of infusion and may resolve if the infusion rate is slowed. Slower infusion rates should be considered for patients with renal dysfunction.

Who can be treated with HepaGam B™?

HepaGam B™ is most effective in HBsAg positive patients with no or low levels of HBV replication at the time of liver transplantation.

How is HepaGam B™ taken?
Usual dose:

Each dose of 35 mL (10,920 international units) HepaGam B™ will be given by an intravenous injection taking approximately 20 minutes.

The typical dose schedule is as follows:

• first dose during liver transplantation operation
• daily doses for the first week post-operative
• once every two weeks for the first 3 months post-operative
• once a month thereafter

Overdose:

The consequences of an overdose are not known. In case of an overdose, patients should consult their doctor.

Missed Dose:

If a scheduled dose is missed, it should be given as soon as possible after the missed dose. The doctor will adjust the patient's dosing schedule if required.

What else should patients know about taking HepaGam B™?

HepaGam B™ is made from human plasma. Products made from human plasma may contain infectious agents, such as viruses and theoretically, the Creutzfeldt Jakob disease agent. The manufacturing process includes both a Planova 35 nm virus filter that effectively removes lipid-enveloped and non-enveloped viruses based on size and a solvent/detergent treatment step (using tri-n-butyl phosphate and Triton X-100®) 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.

Allergic or anaphylactic reactions are rare. These reactions can occur in patients with a history of allergy to blood products or in patients lacking the IgA blood protein.

Where can I learn more about HepaGam B™?

Contact the sponsor, Cangene Corporation, at: 1-877-CANGENE (226-4363).