How to Use Lymphoseek®1,2
Lymphoseek is a radioactive diagnostic agent and is supplied as a kit that should be stored in your facility at room temperature. It is prepared by radiolabeling with technetium Tc 99m and diluting with the supplied diluent prior to use.
As a fully standardized reagent, Lymphoseek requires little or no manipulation before injection. Recommended administration routes are subcutaneous, intradermal, subareolar, or peritumoral.
Review this section for more information on how to use Lymphoseek in your patients to assist in the localization of lymph nodes draining a primary tumor site.
Dosing and Administration
Learn more about the dosing and administration of Lymphoseek, including the recommended time from administration to lymphatic mapping.
Navidea supports your use of Lymphoseek through dedicated resources and clinical expertise, and a corporate commitment to improving diagnostic accuracy and patient care.
Lymphoseek is a radioactive diagnostic agent indicated with or without scintigraphic imaging for:
- Lymphatic mapping using a handheld gamma counter to locate lymph nodes draining a primary tumor site in patients with solid tumors for which this procedure is a component of intraoperative management.
- Guiding sentinel lymph node biopsy using a handheld gamma counter in patients with clinically node negative squamous cell carcinoma of the oral cavity, breast cancer or melanoma.
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.
To report suspected adverse reactions, contact Navidea Biopharmaceuticals, Inc. at 1-800-476-5270 or FDA at 1 800-FDA-1088 or www.fda.gov/medwatch.