Technetium (^99mTc) tilmanocept

Technetium (^99mTc) tilmanocept
Clinical data
Trade names	Lymphoseek
Other names	technetium Tc 99m tilmanocept
AHFS/Drugs.com	Micromedex Detailed Consumer Information
License data	US DailyMed: Tilmanocept;
Pregnancy; category	AU: C; ;
Routes of; administration	Intradermal, subcutaneous, intratumor
ATC code	V09IA09 (WHO) ;
Legal status
Legal status	AU: S4 (Prescription only); UK: POM (Prescription only); US: ℞-only; EU: Rx-only;
Pharmacokinetic data
Elimination half-life	1.75 to 3.05 hours at injection site
Identifiers
	IUPAC name Dextran 3-[(2-aminoethyl)thio]propyl 17-carboxy-10,13,16-tris(carboxymethyl)-8-oxo-4-thia-7,10,13,16-tetraazaheptadec-1-yl 3-[[2-[[1-imino-2-(D-mannopyranosylthio)ethyl]amino]ethyl]thio]propyl ether technetium-99m complexes;
CAS Number	1262984-82-6;
UNII	8IHI69PQTC;
KEGG	D11543;
Chemical and physical data
Formula	(C6H10O5)n(C19H28N4O9S99mTc)3–8(C13H24N2O5S2)12–20(C5H11NS)0–17
Molar mass	15,281–23,454 g/mol

Technetium (^99mTc) tilmanocept, sold under the brand name Lymphoseek, is a radiopharmaceutical diagnostic imaging agent used to locate lymph nodes which may be draining from tumors, and assist doctors in locating lymph nodes for removal during surgery.^[6]

The most common side effects include pain or irritation at the injection site.^[7]

It was approved for medical use in the United States in March 2013,^[4]^[7] and in the European Union in November 2014.^[5]

Medical uses

In the US, technetium (^99mTc) tilmanocept is indicated with or without scintigraphic imaging for lymphatic mapping using a handheld gamma counter to locate lymph nodes draining a primary tumor site in people with solid tumors for which this procedure is a component of intraoperative management; and guiding sentinel lymph node biopsy using a handheld gamma counter in people with clinically node negative squamous cell carcinoma of the oral cavity, breast cancer or melanoma.^[4]^[7]

In the EU, technetium (^99mTc) tilmanocept is indicated for imaging and intraoperative detection of sentinel lymph nodes draining a primary tumor in adults with breast cancer, melanoma, or localized squamous cell carcinoma of the oral cavity.^[5] External imaging and intraoperative evaluation may be performed using a gamma detection device.^[5]

History

The safety and effectiveness of technetium (^99mTc) tilmanocept were established in two clinical trials of 332 participants with melanoma or breast cancer.^[7] All participants were injected with technetium (^99mTc) tilmanocept and blue dye, another drug used to help locate lymph nodes.^[7]

References

^ "Lymphoseek kit for the preparation of technetium [99m Tc] tilmanocept injection vial". Therapeutic Goods Administration (TGA). Retrieved 28 October 2020.
^ "Summary for ARTG Entry: 296337 Lymphoseek kit for the preparation of technetium [99m Tc] tilmanocept injection vial" (PDF). Therapeutic Goods Administration (TGA). Retrieved 28 October 2020.
^ "Lymphoseek 50 micrograms kit for radiopharmaceutical preparation - Summary of Product Characteristics (SmPC)". (emc). 18 May 2020. Retrieved 28 October 2020.
^ ^a ^b ^c ^d "Kit for the preparation of Lymphoseek (technetium tc 99m tilmanocept)- tilmanocept kit". DailyMed. 8 July 2019. Retrieved 28 October 2020.
^ ^a ^b ^c ^d "Lymphoseek EPAR". European Medicines Agency (EMA). 17 September 2018. Retrieved 28 October 2020. Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
^ Marcinow AM, Hall N, Byrum E, Teknos TN, Old MO, Agrawal A (September 2013). "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". JAMA Otolaryngology–Head & Neck Surgery. 139 (9): 895–902. doi:10.1001/jamaoto.2013.4239. PMC 4301415. PMID 24051744.
^ ^a ^b ^c ^d ^e "FDA approves Lymphoseek to help locate lymph nodes in patients with certain cancers" (Press release). U.S. Food and Drug Administration (FDA). 13 March 2013. Archived from the original on 30 March 2014. This article incorporates text from this source, which is in the public domain.

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[1] "Lymphoseek kit for the preparation of technetium [99m Tc] tilmanocept injection vial". Therapeutic Goods Administration (TGA). Retrieved 28 October 2020.

[2] "Summary for ARTG Entry: 296337 Lymphoseek kit for the preparation of technetium [99m Tc] tilmanocept injection vial" (PDF). Therapeutic Goods Administration (TGA). Retrieved 28 October 2020.

[3] "Lymphoseek 50 micrograms kit for radiopharmaceutical preparation - Summary of Product Characteristics (SmPC)". (emc). 18 May 2020. Retrieved 28 October 2020.

[Lymphoseek_FDA_label-4] "Kit for the preparation of Lymphoseek (technetium tc 99m tilmanocept)- tilmanocept kit". DailyMed. 8 July 2019. Retrieved 28 October 2020.

[Lymphoseek_EPAR-5] "Lymphoseek EPAR". European Medicines Agency (EMA). 17 September 2018. Retrieved 28 October 2020. Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.

[6] Marcinow AM, Hall N, Byrum E, Teknos TN, Old MO, Agrawal A (September 2013). "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". JAMA Otolaryngology–Head & Neck Surgery. 139 (9): 895–902. doi:10.1001/jamaoto.2013.4239. PMC 4301415. PMID 24051744.

[FDA_PR-7] "FDA approves Lymphoseek to help locate lymph nodes in patients with certain cancers" (Press release). U.S. Food and Drug Administration (FDA). 13 March 2013. Archived from the original on 30 March 2014. This article incorporates text from this source, which is in the public domain.

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