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Lymphoseek Generic Name & Formulations
Legal Class
Rx
General Description
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.
Pharmacological Class
Radioactive diagnostic agent.
How Supplied
Kit—1 (5 vials + 5 diluents; supplies)
Manufacturer
Generic Availability
NO
Lymphoseek Indications
Indications
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.
Lymphoseek Dosage and Administration
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 Contraindications
Not Applicable
Lymphoseek Boxed Warnings
Not Applicable
Lymphoseek Warnings/Precautions
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 Pharmacokinetics
See Literature
Lymphoseek Interactions
Interactions
Co-injection (mixture) with local anesthetics: not recommended.
Lymphoseek Adverse Reactions
Adverse Reactions
Injection site irritation and/or pain.
Lymphoseek Clinical Trials
See Literature
Lymphoseek Note
Not Applicable
Lymphoseek Patient Counseling
See Literature
