Dosing and uses of Lymphoseek (technetium Tc 99m tilmanocept)
Adult dosage forms and strengths
Kit
- 5 Tilmanocept powder vials each containing 250 mcg tilmanocept
- 5 diluent vials for technetium Tc 99m tilmanocept vials containing 4.5 mL of sterile buffered saline
- End product after radiolabeling with technetium: Tc 99m 92.5 MBq (2.5 mCi) and 250 mcg of technetium Tc 99m tilmanocept in 0.5 mL to 5 mL total volume
Lymphatic Mapping & Node Biopsy
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
Breast cancer: May administer through intradermal, subcutaneous, subareolar, and peritumoral injections
Melanoma: May administer through intradermal or subcutaneous injections
Administer 18.5 MBq (0.5 mCi) of technetium Tc 99m tilmanocept at least 15 minutes before initiating intraoperative lymphatic mapping or sentinel node biopsy; complete lymphatic mapping/biopsy within 15 hr of administration
Recommended total injection volume for each patient is 0.1 mL administered in a single syringe; 0.5 mL administered in a single syringe or in multiple syringes (0.1 mL to 0.25 mL each); or 1 mL administered in multiple syringes (0.2 mL to 0.5 mL each)
Administration
Technetium Tc 99m tilmanocept administration should be handled with appropriate safety measures to minimize radiation exposure; use waterproof gloves, effective radiation shielding, and appropriate safety measures when preparing and handling technetium Tc 99m tilmanocept
Total injection volume and the number of sites to be injected should be known before preparing technetium Tc 99m tilmanocept
Each radiolabled technetium Tc 99m tilmanocept vial contains sufficient amount to provide doses for up to four patients when prepared according to the instructions
Radiolabeled technetium Tc 99m tilmanocept is to be used within 6 hr of its preparation
Head & Neck Cancers (Orphan)
Orphan designation for use in sentinel lymph node detection with a hand-held gamma-counter, with scintigraphic imaging, in patients with cancer of the head and neck
Sponsor
- Navidea Biopharmaceuticals; 5600 Blazer Parkway, Suite 200; Dublin, OH 43017
Pediatric dosage forms and strengths
Safety and efficacy not established
Lymphoseek (technetium Tc 99m tilmanocept) adverse (side) effects
<1%
Injection site reactions
Pain
Warnings
Contraindications
None
Cautions
Observe for hypersensitivity signs and symptoms following injection
Have resuscitation equipment and trained personnel available at the time of administration
Pregnancy and lactation
Pregnancy category: C
Lactaion: Excercise caution when administering to a nursing mother
Pregnancy categories
A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.
C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.
D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.
X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.
NA: Information not available.
Pharmacology of Lymphoseek (technetium Tc 99m tilmanocept)
Mechanism of action
The macromolecule accumulates in lymphatic tissue and selectively binds to mannose binding receptor (CD206) located on the surface of macrophages and dendritic cells; macromolecule consists 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
Used with a hand-held gamma counter to assist in the localization of lymph nodes draining a primary tumor site in patients with breast cancer or melanoma
Distribution
Detectable in lymphnodes within 15 min and up to 30 hr after injection
Elimination
Half-life: 1.75-3.05 hr
Administration
Preparation
Kit for the preparation contains 5 sets of 2 vials - a tilmanocept powder vial and a diluent viaL
Tilmanocept powder vial contains 250 mcg of tilmanocept from which 50 mcg is intended for administration to a patient
The diluent for technetium Tc 99m tilmanocept vial contains 4.5 mL of sterile buffered saline and is used to dilute technetium Tc 99m tilmanocept after the radiolabeling procedure.
Amount of diluent used varies, depending on the total injection volume and the number of syringes used for each patient
The vial components of the kit for the preparation are sterile, nonpyrogenic, and are intended solely for use in the preparation of technetium Tc 99m tilmanocept; do not administer the unprepared vial components of the kit directly to a patient
Follow aseptic procedures during preparation and administration
Use reconstituted product within 6 hours of its preparation
Storage
Store reconstituted product in radiation shielding at room temperature
