Vivaglobin [Immune Globulin Subcutaneous (Human)] - Risk of Thrombotic Events (Blood Clots) - For the Public

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Contact: Marketed Health Products Directorate

The Health Products and Food Branch (HPFB) posts on the Health Canada Web site safety alerts, public health advisories, press releases and other notices as a service to health professionals, consumers, and other interested parties. These advisories may be prepared with Directorates in the HPFB which includes pre-market and post-market areas as well as market authorization holders and other stakeholders. Although the HPFB grants market authorizations or licenses for therapeutic products, we do not endorse either the product or the company. Any questions regarding product information should be discussed with your health professional.

This is duplicated text of a letter from CSL Behring Canada, Inc.
Contact the company for a copy of any references, attachments or enclosures .

PUBLIC COMMUNICATION
Health Canada Endorsed Important Safety Information on Vivaglobin

April 11, 2011

Subject: Risk of blood clots with the use of Vivaglobin^® [Immune Globulin Subcutaneous (Human)]

To Whom It May Concern,

CSL Behring Canada Inc, in collaboration with Health Canada, would like to inform you of reports of serious thrombotic events (blood clots) following the use of Vivaglobin^®, Immune Globulin Subcutaneous (Human).

Vivaglobin^® is used to treat adults and children with primary immune deficiency (PID), a condition in which a person's natural defense system or immune system is not functioning properly.

There have been very rare reports of blood clots associated with use of Vivaglobin^®. The risk of forming blood clots is well known for immune globulin products injected into veins, but has now been reported when injected under the skin. These events include deep vein thrombosis (blood clot in the legs), pulmonary embolism (blood clot in the lung), and stroke (blood clot in the brain). Nineteen thrombotic events were reported worldwide in patients treated with Vivaglobin^®, some of them following inappropriate injection into a vein; no cases have been reported in Canada.

Some of these patients had risk factors for blood clots, which included heart disease, previous blood clots, excess weight, use of birth control pills, high levels of protein and cholesterol in the blood, the use of a catheter, and immobility.

Vivaglobin^® is authorized to be given only by injection under the skin (subcutaneously). It is important that the instructions in the Patient Instructions provided with Vivaglobin^® and those given by your health-care provider, including particular symptoms to look for, be followed. There are risk factors such as dehydration, blood clotting disorders and heart disease that may increase the risk of clots forming in blood vessels during immunoglobulin replacement therapy. If you have any of these risk factors, please discuss with your health-care professional so that appropriate precautions be taken, including administering Vivaglobin^® at the slowest administration rate possible.

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 thrombotic events or other serious or unexpected adverse reactions in patients receiving Vivaglobin^® should be reported to CSL Behring or to Health Canada.

Sincerely,

original signed by

David Barnes
Medical Director
CSL Behring Canada