Overview
11 DESCRIPTION Chemical Characteristics The active ingredient in Lymphoseek, a radioactive diagnostic agent, is technetium Tc 99m tilmanocept. Technetium Tc 99m binds to the diethylenetriaminepentaacetic acid (DTPA) moieties of the tilmanocept molecule. • Chemically, technetium Tc 99m tilmanocept consists of technetium Tc 99m, dextran 3-[(2-aminoethyl)thio]propyl...
Mechanism of Action
12 CLINICAL PHARMACOLOGY 12.1 Mechanism of Action Lymphoseek (technetium Tc 99m tilmanocept) is a radioactive diagnostic agent. It accumulates in lymphatic tissue and selectively binds to mannose binding receptors (CD206) located on the surface of macrophages and dendritic cells. Technetium Tc 99m tilmanocept is a macromolecule consisting of multiple units of diethylenetriaminepentaacetic acid (DTPA) and mannose, each covalently attached to a 10 kDa dextran backbone. The mannose acts as a ligand for the receptor, and the DTPA serves as a chelating agent for labeling with technetium Tc 99m. 12.2 Pharmacodynamics In in vitro studies, technetium Tc 99m tilmanocept exhibited binding to human mannose binding receptors with a primary binding site affinity of K d = 2.76 x 10 -11 M.
Indications
- 1 INDICATIONS AND USAGE 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 adult and pediatric patients age one month and older 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.
Common Doses
- 50 mcg
- 0.1 mL
- 0.5 mL
- 0.25 mL
Dosage
2 DOSAGE AND ADMINISTRATION • Lymphoseek is supplied as a kit and must be prepared by radiolabeling with technetium Tc 99m and diluting with the supplied diluent or pharmacy-available sterile 0.9% sodium chloride injection prior to use. ( 2.3 ) • Use aseptic technique and radiation safety precautions during Lymphoseek preparation and handling. Determine the total injection volume and number of sites to be injected for each patient before preparing Lymphoseek. ( 2.1 , 2.3 ) • Recommended dose of Lymphoseek is 18.5 MBq (0.
Contraindications
- 4 CONTRAINDICATIONS None. None. ( 4 )
Side Effects
- 6 ADVERSE REACTIONS The most common adverse reactions (incidence
Interactions
- No major interactions listed on the FDA label. Always consult a healthcare professional.