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

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Contact: Marketed Health Products Directorate

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

Health Canada Endorsed Important Safety Information on Vivaglobin

April 11, 2011

Subject: Risk of Thrombotic Events with Subcutaneous or Inappropriate Intravenous use of Vivaglobin^® [Immune Globulin Subcutaneous (Human)]

Dear Health Care Professional,

CSL Behring Canada Inc, in collaboration with Health Canada, would like to inform you of post-marketing reports that indicate an association of serious thrombotic events with the use of Vivaglobin^®, Immune Globulin Subcutaneous (Human).

Vivaglobin^® is authorized for the treatment of adult and pediatric patients with primary immune deficiency (PID).

Post-marketing reports indicate that the use of Vivaglobin^®, a subcutaneous immune globulin product for treatment of primary immune deficiency (PID), has been associated with very rare serious thrombotic events, including deep venous thrombosis, pulmonary embolism and stroke. Nineteen TEES have been reported internationally in patients treated with Vivaglobin; no Canadian cases have been reported.

When reported, risk factors in post-marketing thrombotic event reports for Vivaglobin, have included pre-existing cardiovascular disorders, prior thrombotic event, obesity, oral estrogen use, hyperlipoproteinemia, in-dwelling catheter, and immobility.

In response to reports that certain intravenous immunoglobulin products have higher levels of procoagulant activity that could predispose patients to thrombosis, CSL Behring developed research assays for product assessment. In-house research testing by CSL Behring laboratories revealed procoagulant activity in Vivaglobin^®. The clinical significance of these laboratory findings is uncertain.

Vivaglobin^® is authorized for subcutaneous infusion only; follow the instructions for subcutaneous administration presented in the current Product Monograph. Hyperviscosity from any cause including dehydration, hypercoagulable disorders, and multiple cardiac risk factors may also confer thrombosis risk in the setting of immune globulin product administration. In all patients receiving Vivaglobin^®, physicians and patients should take precautions to minimize risk, including administration of Vivaglobin^® at the minimum rate practicable. For patients with pre-existing risk factors for thrombosis, prescribers should make individualized risk benefit decisions.

Patients should be informed of the symptoms of a thrombotic event, and what to do if these occur.

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 cases 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