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

 

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

 

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

 

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

 

 

References: 1. LYMPHOSEEK Injection [prescribing information]. Dublin, OH: Navidea; September 2014. 2. Sondak V, King DW, Zager JS, et al. Combined analysis of Phase III trials evaluating Tc99m tilmanocept and vital blue dye for identification of sentinel lymph nodes in clinically node-negative cutaneous melanoma. Ann Surg Oncol. 2013;20:680-8. 3. Wallace AM, Han LK, Povoski SP, et al. Comparative evaluation of [99mTc] tilmanocept for sentinel lymph node mapping in breast cancer patients: results of two Phase 3 trials. Ann Surg Oncol. 2013; doi 10.1245/s10434-013-2887-8. 4. Vera, DR, Tokin CA. Tilmanocept: a synthetic receptor-targeted molecule for sentinel lymph node mapping. International Atomic Energy Agency (IAEA) Publication 2014; Chapter X: In Press.


*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 Cardinal Health at 1.800.618.2768 or FDA at 1.800.FDA.1088 or www.fda.gov/medwatch.

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