TECHNETIUM TC-99M TILMANOCEPT

Description
Sources: http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/202207s002lbl.pdf
Curator's Comment: description was created based on several sources, including http://www.ncbi.nlm.nih.gov/pubmed/?term=25069859

Technetium (99mTc) tilmanocept, trade name Lymphoseek, is a radiopharmaceutical diagnostic imaging agent approved for the imaging of lymph nodes. It is used to locate those lymph nodes which may be draining from tumors, and assist doctors in locating those lymph nodes for removal during surgery.

Originator

Approval Year

Targets

Primary Target	Pharmacology	Condition	Potency
Macrophage mannose receptor 1 1 Target ID: P22897 Gene ID: 4360.0 Gene Symbol: MRC1 Target Organism: Homo sapiens (Human) Sources: http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/202207s002lbl.pdf	Binding Agent 1076		27.6 pM [Kd]

Conditions

Condition	Modality	Highest Phase	Product
Squamous cell carcinoma of the oral cavity 1 Sources: http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/202207s002lbl.pdf	Diagnostic	Approved 8583	LYMPHOSEEK Approved Use 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 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 Launch Date 2013
Breast cancer 432 Sources: http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/202207s002lbl.pdf	Diagnostic	Approved 8583	LYMPHOSEEK Approved Use 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 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. Launch Date 2013
Melanoma 88 Sources: http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/202207s002lbl.pdf	Diagnostic	Approved 8583	LYMPHOSEEK Approved Use 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 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 Launch Date 2013

PubMed

Title	Date	PubMed
Comparison of [(99m)Tc]tilmanocept and filtered [(99m)Tc]sulfur colloid for identification of SLNs in breast cancer patients.	2015-01	25069859
Less is better? Intraindividual and interindividual comparison between 0.075 mmol/kg of gadobenate dimeglumine and 0.1 mmol/kg of gadoterate meglumine for cranial MRI.	2014-07	24816087
Mapping lymph nodes in cancer management - role of (99m)Tc-tilmanocept injection.	2014	25028560
Use of a novel receptor-targeted (CD206) radiotracer, 99mTc-tilmanocept, and SPECT/CT for sentinel lymph node detection in oral cavity squamous cell carcinoma: initial institutional report in an ongoing phase 3 study.	2013-09	24051744
Combined analysis of phase III trials evaluating [⁹⁹mTc]tilmanocept and vital blue dye for identification of sentinel lymph nodes in clinically node-negative cutaneous melanoma.	2013-02	23054107

Sample Use Guides

In Vivo Use Guide

Administer 18.5 MBq (0.5 mCi) of Lymphoseek at least 15 minutes before initiating intraoperative lymphatic mapping. Complete lymphatic mapping within 15 hours of Lymphoseek injection. Recommended administration routes are intradermal, subcutaneous, and peritumoral injections. Each radiolabled Lymphoseek vial contains sufficient amount to provide doses for up to four patients when prepared according to the instructions. The radiolabeled Lymphoseek is to be used within 6 hours of its preparation.

Route of Administration: Other

In Vitro Use Guide

Unknown

Name

Type

Language

TECHNETIUM TC 99M TILMANOCEPT

Preferred Name

English

TECHNETIUM TC-99M TILMANOCEPT

Common Name

English

TECHNETIUM TC 99M TILMANOCEPT [USAN]

Common Name

English

LYMPHOSEEK

Brand Name

English

TECHNETIUM TC 99M TILMANOCEPT [MI]

Common Name

English

1600

Code

English

Technetium Tc 99m tilmanocept [WHO-DD]

Common Name

English

TECHNETIUM TC-99M TILMANOCEPT [ORANGE BOOK]

Common Name

English

Classification Tree Code System Code

FDA ORPHAN DRUG

427814