Date: March 11, 2011
FDA has received postmarketing reports of serious thrombotic adverse events associated with use of Vivaglobin manufactured by CSL Behring. Vivaglobin is indicated for treatment of Primary Humoral Immunodeficiency, and is administered subcutaneously. The risk of arterial and venous thrombosis following intravenous Immune Globulin (IGIV) products is well known, however postmarketing reports suggest that a degree of risk is associated with subcutaneous administration of Vivaglobin. Vivaglobin is not approved for intravenous use and inadvertent intravenous use of Vivaglobin may carry a higher risk. The manufacturer has informed FDA that in-house research testing revealed procoagulant activity in Vivaglobin. The significance of these findings is uncertain.
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.
Hyperviscosity, hypercoagulable disorders, and multiple cardiac risk factors may also confer thrombosis risk in the setting of immune globulin product administration.
Do not infuse Vivaglobin intravenously.
Infuse at the minimum rate practicable.
Follow package insert instructions to ensure subcutaneous infusion
Inform patients of signs and symptoms of thrombotic events, including: shortness of breath, pain and swelling of a limb, focal neurological deficits, chest pain, and other manifestations of thrombotic and embolic events.
FDA continues to monitor reports of thrombotic adverse events associated with intravenous and subcutaneous immune globulin products. FDA is working with manufacturers to identify strategies that lower the risk of thrombotic adverse events.
Reporting Adverse Events
You may also report adverse events to the U.S. Food and Drug Administration at 1-800-FDA-1088, online at www.fda.gov/medwatch, or by mail using Medwatch form FDA 3500 postage paid from, the FDA Safety Information and Adverse Event Reporting Program, 5600 Fishers Lane, Rockville, MD 20852-9787. Please provide the lot number(s) of products associated with reported adverse events whenever possible.
You may report any adverse event you encounter with a CSL Behring product to CSL Behring U.S. Clinical Safety and Pharmacovigilance: 1-866-915-6958. Please provide the lot number(s) of products associated with reported adverse events whenever possible.