Lymphoseek

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

About Lymphoseek®

The first and only agent specifically designed for targeted lymphatic mapping and guiding sentinel lymph node biopsy,* Lymphoseek provides accurate and precise lymph node identification in patients with solid tumors.1,2

Discover how Lymphoseek can be used in your facility to provide actionable information that can enhance pathological evaluation and inform patient staging and management decisions.

 

Why Lymphoseek?

Discover the benefits of Lymphoseek for nuclear medicine physicians and surgeons.
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Mechanism of Action

As the first and only receptor-targeted lymphatic mapping agent, Lymphoseek works by way of a distinct mechanism of action.1-4
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Clinical Efficacy

The clinical efficacy of Lymphoseek was demonstrated in three pivotal Phase 3 open-label studies.2-4
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Safety

Review the safety and tolerability profile of Lymphoseek.2
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*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.