Kit For The Preparation Of Lymphoseek

Kit For The Preparation Of Lymphoseek

Kit For The Preparation Of Lymphoseek Recall

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Questions & Answers

Side Effects & Adverse Reactions

There is currently no warning information available for this product. We apologize for any inconvenience.

Legal Issues

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FDA Safety Alerts

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Manufacturer Warnings

There is currently no manufacturer warning information available for this drug.

FDA Labeling Changes

There are currently no FDA labeling changes available for this drug.

Uses

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 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.

History

There is currently no drug history available for this drug.

Other Information

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 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 complexes.
  • The molecular formula of technetium Tc 99m tilmanocept is [C6H10O5]n.(C19H28N4O9S99mTc)b.(C13H24N2O5S2)c.(C5H11NS)a. It contains 3-8 conjugated DTPA (diethylenetriaminepentaacetic acid) molecules (b); 12-20 conjugated mannose molecules (c) with 0-17 amine side chains (a) remaining free.
  • The calculated average molecular weight of tilmanocept ranges from 15,281 to 23,454 g/mol.
  • Technetium Tc 99m tilmanocept has the following structural formula:

image description

Lymphoseek (technetium Tc 99m tilmanocept) injection is supplied as a Kit which contains:

  • Tilmanocept Powder vial contains the non-radioactive ingredients needed to produce technetium Tc 99m tilmanocept. The vial contains a sterile, non-pyrogenic, white to off-white lyophilized powder (under nitrogen) that consists of a mixture of 250 mcg tilmanocept, 20 mg trehalose dihydrate, 0.5 mg glycine, 0.5 mg sodium ascorbate, and 0.075 mg stannous chloride dihydrate.
  • DILUENT for Lymphoseek contains a preservative formulated for Lymphoseek. The vial contains 4.5 mL sterile buffered saline consisting of 0.04% (w/v) potassium phosphate, 0.11% (w/v) sodium phosphate (heptahydrate), 0.5% (w/v) sodium chloride, and 0.4% (w/v) phenol. The pH is 6.8 – 7.2. No other diluent should be used.

Physical Characteristics

Technetium Tc 99m decays by isomeric transition with a physical half-life of approximately 6 hours. The principal photon that is useful for detection and imaging studies is listed in Table 4.

Table 4. Principal Radiation Emission Data
From: Kocher, D.C. Radioactive decay data tables. DOE/TIC-11026, 108 (1981).
Radiation Mean % Disintegration Mean Energy (keV)
Gamma-2 89.1 140.5

External Radiation

The linear mass energy absorption attenuation coefficient for Tc 99m is 18.9 cm-1. The first half-value layer is 0.037 cm of lead (Pb). The use of a 0.25 cm thick standard radiation lead shield will attenuate the radiation emitted by millicurie amounts of technetium Tc 99m by a factor of about 100. A range of values for the relative attenuation of the radiation of technetium Tc 99m that results with various thicknesses of lead shielding are displayed in Table 5.

Table 5. Radiation Attenuation by Lead Shielding
Shield Thickness, cm of lead (Pb) Coefficient of Attenuation
0.037 0.5
0.12 10-1
0.24 10-2
0.36 10-3
0.49 10-4

To correct for physical decay of the radionuclide, the fractions that remain at selected intervals after the time of calibration are shown in Table 6. 

Table 6. Physical Decay Chart; Tc 99m, Half-Life of approximately 6 Hours
Hours Fraction Remaining
0 1
1 0.891
3 0.708
6 0.501
12 0.251
15 0.178

Kit For The Preparation Of Lymphoseek Manufacturers


  • Navidea Biopharmaceuticals, Inc.
    Kit For The Preparation Of Lymphoseek (Technetium Tc 99m Tilmanocept) (Tilmanocept) Kit [Navidea Biopharmaceuticals, Inc.]

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