HepaGam B [Hepatitis B Immune Globulin (Human) Injection] - Theoretical Risk of Thrombotic Events with Intravenous Administration and Related Labeling Update - For the Public

Starting date:

June 14, 2012

Posting date:

June 14, 2012

Type of communication:

Public Communication

Subcategory:

Biologic/vaccine

Source of recall:

Health Canada

Audience:

General Public

Identification number:

RA-14806

This is duplicated text of a letter from Cangene Corporation.

Contact the company for a copy of any references, attachments or enclosures.

Notice about Health Canada advisories

Public Communication - Health Canada Endorsed Important Safety Information on HepaGam B [Hepatitis B Immune Globulin (Human) Injection]

June 14, 2012

Subject: Theoretical Risk of Blood Clots with Intravenous HepaGam B^® [Hepatitis B Immune Globulin (Human) Injection]

To Whom It May Concern,

Cangene Corporation, in cooperation with the Health Canada, would like to inform you of the possibility of developing blood clots after receiving HepaGam B^®.

HepaGam B^® is used to prevent hepatitis B infection after exposure to hepatitis B virus (called post-exposure prophylaxis) and to prevent hepatitis B from coming back following liver transplant in patients with hepatitis B. HepaGam B^® belongs to a group of biological medicines derived from human blood known as immune globulins. It is administered in hospitals by infusion through the veins (intravenously) or by injection into the muscle (intramuscularly).

• There is a theoretical risk of developing blood clots when HepaGam B^® is given through the veins.
• Certain conditions may increase your risk of blood clots, such as dehydration, blood clotting disorders, advanced age, and heart disease.
• The symptoms of a blood clot include: shortness of breath; pain and swelling of a limb; pain in the chest area; sudden difficulty in concentration, focus or balance, or anything else that becomes suddenly unusual.
• See a doctor if you develop any of these symptoms or are concerned about the use of HepaGam B^®.

There have been very rare reports of blood clots associated with the use of other immune globulin products. These events include deep vein thrombosis (blood clot in the legs), pulmonary embolism (blood clot in the lung), myocardial infarction (heart attack), and stroke (blood clot in the brain). Although these events have not been reported with HepaGam B^®, it is possible that these events could occur after receiving HepaGam B^® through the veins. 

It is important that you follow the Patient Instructions provided with HepaGam B^® as well as any instruction given by your doctor. In particular, it is important that you watch for the symptoms mentioned above. There are risk factors such as the ones mentioned above that may increase the risk of developing clots after receiving an immune globulin product. If you have any risk factors noted above, please discuss this with your doctor so that appropriate precautions can be taken, including administering HepaGam B^® more slowly.

Managing marketed health product-related adverse reactions depends on health care professionals and consumers reporting them. Reporting rates determined on the basis of spontaneously reported post-marketing adverse reactions are generally presumed to underestimate the risks associated with health product treatments. Any case of serious blood clot or other serious or unexpected adverse reactions in patients receiving HepaGam B^® should be reported to Cangene Corporation or Health Canada.

Please report any adverse events you encounter with Cangene product to Cangene Corporation Pharmacovigilance at 1-800-768-2304. Please provide the lot number(s) of products associated with reported adverse events, whenever possible.

Cangene Corporation

155 Innovation Drive, Winnipeg, MB

Canada, R3T 5Y3

Tel: 204-275-4509

Fax: 204-275-4330

Cell: 204-295-2935 (24 hour access)

Toll free number (for USA and Canada) 800-768-2304 (24 hour access)

E-mail: pharmacovigilance@cangene.com

To report suspected adverse reactions to these or other health products, please contact Health Canada's Canada Vigilance Program toll-free at 1-866-234-2345, or visit the MedEffect™ Canada Web site for information on how to report.

The Reporting Forms, postage paid labels, and Guidelines can be found on the MedEffect™ Canada Web site in the Adverse Reaction Reporting section.

For other health product inquiries related to this communication, please contact Health Canada at:

Marketed Health Products Directorate

E-mail: mhpd_dpsc.public@hc-sc.gc.ca

Telephone: 613-954-6522

Fax: 613-952-7738

original signed by

Pam Bobbette

Director of Quality

Cangene Corporation