Human Immune Globulin
June 26, 2013
FDA is requiring manufacturers of all human immune globulin dosage forms (intravenous, intramuscular, and subcutaneous) to update product labeling to include a boxed warning for risk of thrombosis. This includes adding information to the existing boxed warning for intravenous forms of human immune globulin and addition of a new boxed warning for intramuscular and subcutaneous forms. The boxed warning includes the following information:
- There is a risk of thrombosis with all human immune globulin products.
- Risk factors for thrombosis include: advanced age, cardiac risk factors, history of venous or arterial thrombosis, hypercoagulable conditions, hyperviscosity, indwelling central vascular catheters, prolonged immobilization, and use of estrogens.
- Administer the lowest available concentration at the lowest infusion rate possible in patients with known risk factors.
- Risk of thrombosis is still present in patients without known risk factors.
- Adequately hydrate patients prior to human immune globulin administration.
- Assess blood viscosity and monitor for signs and symptoms of thrombosis in patients who are at risk of hyperviscosity.
This new human immune globulin class warning for risk of thrombosis is supported by postmarketing adverse event reports as well as a retrospective analysis of a large health claims-related database. Warnings regarding thrombosis are currently included in all the product labels for human immune globulin products; however, FDA believes that more prominent placement of this information will help to reduce the incidence of thrombosis when these products are used.
Be aware of the risks of thrombosis associated with human immune globulin and discuss these with your patient or healthcare provider. Evaluate patients for possible risk factors and treat appropriately. Monitor closely for signs or symptoms of thrombosis and advise patients to report any symptoms of thrombosis following treatment with human immune globulin.
Additional information is available at the following link:
- FDA Safety Communication:
June 26, 2013; University of Utah, Drug Information Service. Copyright 2013, Drug Information Service, University of Utah, Salt Lake City, UT.