In clinical trials with LYMPHOSEEK®, no serious hypersensitivity reactions were reported, however LYMPHOSEEK® may pose a risk of such reactions due to its chemical similarity to dextran. Serious hypersensitivity reactions have been associated with dextran and modified forms of dextran (such as iron dextran drugs).
Prior to the administration of LYMPHOSEEK®, patients should be asked about previous hypersensitivity reactions to drugs, in particular dextran and modified forms of dextran. Resuscitation equipment and trained personnel should be available at the time of LYMPHOSEEK® administration, and patients observed for signs or symptoms of hypersensitivity following injection.
Any radiation-emitting product may increase the risk for cancer. Adhere to dose recommendations and ensure safe handling to minimize the risk for excessive radiation exposure to patients or health care workers.
In clinical trials, no patients experienced serious adverse reactions and the most common adverse reactions were injection site irritation and/or pain (<1%).
Please see full prescribing information at www.lymphoseek.com
To report suspected adverse reactions, contact Cardinal Health at 1.800.618.2768 or FDA at 1.800.FDA.1088 or www.fda.gov/medwatch