The U.S. Food and Drug Administration (FDA) has approved Lymphoseek (technetium Tc 99m tilmanocept) Injection, a novel product indicated for use in lymphatic mapping procedures to assist in the localization of lymph nodes draining a primary tumor in patients with breast cancer or melanoma. Lymphoseek is a receptor targeted radiopharmaceutical designed to identify these lymph nodes which have the highest probability of harboring cancer and thereby assist physicians in the staging of such patients
LYMPHOSEEK Rx
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Generic Name and Formulations:
Technetium Tc 99m tilmanocept 250mcg; pwd for SC, intradermal, or peritumoral inj after reconstitution. After radiolabeling (with technetium Tc 99m + dilution); contains approx. 92.5 MBq (2.5 mCi) and 250mcg of technetium Tc 99m tilmanocept in 0.5–5mL total volume.
Company:
Navidea Biopharmaceuticals

Select therapeutic use: Imaging agents
Indications for LYMPHOSEEK:
Using a hand-held gamma counter: for lymphatic mapping to assist in the localization of lymph nodes draining a primary tumor site in patients with breast cancer or melanoma; for guiding sentinel lymph node biopsy in patients with clinically node negative squamous cell carcinoma (SCC) of the oral cavity.

Adult:
See full labeling. Determine the planned injection technique and the number of injections per patient prior to preparing dose. May be administered as a single injection or multiple injections. Give 18.5MBq (0.5mCi) as a radioactivity dose and 50mcg as a mass dose, at least 15mins before initiating intraoperative lymphatic mapping; do not delay mapping >15hrs after injection. Total injection volume per patient: 0.1mL in single syringe; 0.5mL in single or in multiple syringes (0.1–0.25mL each); or 1mL in multiple syringes (0.2–0.5mL each). Route of administration: Breast cancer: intradermal, SC, subareolar, peritumoral; Melanoma: intradermal or SC.

Children:
<18yrs: not established.

Warnings/Precautions:
Previous hypersensitivity to dextran or other modified forms. Have resuscitation equipment available. Risk of radiation exposure. Should only be used by trained and experienced physicians in the safe use and handling of radioactive materials to minimize radiation exposure. In females of reproductive potential: administer within 10 days following the onset of menses or perform a pregnancy test within 48hrs prior to the administration. Pregnancy (Cat. C). Nursing mothers (discard milk for at least 4hrs after administration).

Interactions:
Co-injection (mixture) with local anesthetics: not recommended.

Pharmacological Class:
Radioactive diagnostic agent.

Adverse Reactions:
Injection site irritation and/or pain.

How Supplied:
Kit—1 (5 vials + 5 diluents; supplies)