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 solid tumors for which this procedure is a component of intraoperative management; for guiding sentinel lymph node biopsy in patients with clinically node negative squamous cell carcinoma of the oral cavity, breast cancer or melanoma.
Adults and Children:
<1month: not established. 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. ≥1month: give 18.5MBq (0.5mCi) as a radioactivity dose and 50mcg as a mass dose, at least 15mins prior to initiating lymphatic mapping or node biopsy; complete procedures within 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.
LYMPHOSEEK 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 radionuclides to minimize radiation exposure. Pregnancy. Nursing mothers (pump/discard milk for 24hrs after administration).
LYMPHOSEEK Classification:
Radioactive diagnostic agent.
LYMPHOSEEK Interactions:
Co-injection (mixture) with local anesthetics: not recommended.
Adverse Reactions:
Injection site irritation and/or pain.
Generic Drug Availability:
NO
How Supplied:
Kit—1 (5 vials + 5 diluents; supplies)
