Canada Warns of Blood Clot Risk with Vivaglobin

Health Canada (HC), in collaboration with CSL Behring Canada Inc, just announced that reports of serious thrombotic events—commonly known as blood clots—have been reported 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. Vivaglobin® is a medication that is only administered subcutaneously (injection under the skin). Vivaglobin® administered in any other way, such as into a vein, is not an approved method and could increase blood clot risks.

The symptoms of a blood clot include difficulty breathing; pain and swelling of a limb; pain in the chest area; sudden difficulty in concentration, focus, or balance; or any other event that becomes suddenly unusual. Certain conditions may increase the risk of blood clots and a doctor should be consulted with questions or concerns about use of Vivaglobin®, or if any adverse symptoms are experienced.

There have been some rare reports of blood clots associated with use of Vivaglobin® and the risk of forming blood clots is well known for immune globulin products injected into veins; however, this adverse reaction has now been reported when Vivaglobin® is injected under the skin. These events include deep vein thrombosis, which is a blood clot in the legs; pulmonary embolism, a blood clot in the lung; and stroke, which HC described is a blood clot in the brain. To date, 19 thrombotic events were reported, worldwide, in patients treated with Vivaglobin®, some following inappropriate injection into a vein.

Some patients had risk factors for blood clots, such as 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 only authorized to be given subcutaneously, and it is important that the instructions in the Patient Instructions provided with Vivaglobin®, and those given by the patient’s healthcare 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. Patients with any of these risk factors are urged to discuss these with their healthcare professional so that appropriate precautions are taken, such as administering Vivaglobin® at the slowest administration rate possible.

Health Canada is asking patients to report adverse events to CSL Behring and the Canadian Vigilance Program. CSL Behring can be reached at CSL Behring U.S. Clinical Safety and Pharmacovigilance, toll-free, at 1.866.915.6958. Lot numbers of involved products should be provided, when possible. CSL Behring Canada, Inc.
can be contacted at 55 Metcalfe Street, Suite 1460
Ottawa, Ontario
K1P 6L5

The Canada Vigilance Program can be reached either by submitting an online report at; calling, toll-free, at 1.866.234.2345; or completing a Reporting Form and faxing it to 1.866.678.6789 or mailing it to the Canada Vigilance Program, Health Canada, Postal Locator 0701E, Ottawa, Ontario, K1A 0K9. Reporting Forms, postage paid labels, and Guidelines can be found on the MedEffectTM Canada Web site in the Adverse Reaction Reporting section at:

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