Lymphoseek

The information on this web site is intended for use only by healthcare professionals in the United States.

Mechanism of Action

Targeted to Identify

Lymphoseek®, the first and only receptor-targeted lymphatic mapping agent, works by way of a distinct mechanism of action.1,2,3

Tight binding

As a novel, synthetic soluble solution of tilmanocept, Lymphoseek has a small molecular size (7 nanometers) and carries multiple units of mannose.1-3 This mannose component has a high affinity for receptor proteins known as CD-206, which are found in high concentrations on the surface of macrophages and dendritic cells.1,4 By tightly binding to these mannose receptors, Lymphoseek accumulates in lymphatic tissue within minutes and localizes in tumor-draining lymph nodes.1

moa

Lymphoseek transits through the lymphatic vessels and accumulates in lymph nodes draining from a primary tumor.

moa

The mannose components of Lymphoseek have a high affinity for the CD-206 receptor protein, which are found in high concentrations on the surface of macrophages and dendritic cells.1,4

Clears injection site rapidly

Lymphoseek delivers rapid and consistent injection site clearance. In clinical studies, Lymphoseek was detectable in lymph nodes within 10 minutes and up to 30 hours. It is recommended that lymphatic mapping with Lymphoseek be conducted from 15 minutes and up to 15 hours post-injection.1-3

Identifies lymph nodes

The distinct mechanism of action of Lymphoseek enables reliable identification and localization of lymph nodes draining from a primary tumor.2

moa

The receptor targeting properties of Lymphoseek enable reliable identification and localization of lymph nodes draining from a primary tumor.

*Indication

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.

Important Safety Information

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.