Kit For The Preparation Of Technetium Tc99m Sestamibi

Kit For The Preparation Of Technetium Tc99m Sestamibi

Kit For The Preparation Of Technetium Tc99m Sestamibi Recall

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Questions & Answers

Side Effects & Adverse Reactions

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Legal Issues

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Manufacturer Warnings

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FDA Labeling Changes

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

Uses

Myocardial Imaging: Technetium Tc99m Sestamibi is a myocardial perfusion agent that is indicated for detecting coronary artery disease by localizing myocardial ischemia (reversible defects) and infarction (non-reversible defects), in evaluating myocardial function and developing information for use in patient management decisions. Technetium Tc99m Sestamibi evaluation of myocardial ischemia can be accomplished with rest and cardiovascular stress techniques (e.g., exercise or pharmacologic stress in accordance with the pharmacologic stress agent's labeling).

It is usually not possible to determine the age of a myocardial infarction or to differentiate a recent myocardial infarction from ischemia.

Breast Imaging: Technetium Tc99m Sestamibi is indicated for planar imaging as a second line diagnostic drug after mammography to assist in the evaluation of breast lesions in patients with an abnormal mammogram or a palpable breast mass.

Technetium Tc99m Sestamibi is not indicated for breast cancer screening, to confirm the presence or absence of malignancy, and it is not an alternative to biopsy.

History

There is currently no drug history available for this drug.

Other Information

Each 5 mL vial contains a sterile, non-pyrogenic, lyophilized mixture of:

  • Tetrakis (2-methoxy isobutyl isonitrile) Copper (I) tetrafluoroborate - 1.0 mg
  • Sodium Citrate Dihydrate - 2.6 mg
  • L-Cysteine Hydrochloride Monohydrate - 1.0 mg
  • Mannitol – 20 mg
  • Stannous Chloride, Dihydrate, minimum (SnCl2∙2H2O) - 0.025 mg
  • Stannous Chloride, Dihydrate, (SnCl2∙2H2O) - 0.075 mg
  • Tin Chloride (stannous and stannic) Dihydrate, maximum (as SnCl2∙2H2O) - 0.086 mg

Prior to lyophilization the pH is 5.3 to 5.9. The contents of the vial are lyophilized and stored under nitrogen.

This drug is administered by intravenous injection for diagnostic use after reconstitution with sterile, non-pyrogenic, oxidant-free Sodium Pertechnetate Tc99m Injection. The pH of the reconstituted product is 5.5 (5.0 - 6.0). No bacteriostatic preservative is present.

The precise structure of the technetium complex is Tc99m[MIBI]6+ where MIBI is 2-methoxy isobutyl isonitrile.

11.1 Physical Characteristics

Technetium Tc99m decays by isomeric transition with a physical half-life of 6.02 hours2. Photons that are useful for detection and imaging studies are listed below in Table 3.0.

Table 3.0. Principal Radiation Emission Data
Radiation Mean %/Disintegration Mean Energy (KeV)
Gamma -2 89.07 140.5
2
Kocher, David, C., Radioactive Decay Data Tables, DOE/TIC-11026, 108(1981).
11.2 External Radiation

The specific gamma ray constant for Tc99m is 5.4 microcoulombs/Kg-MBq-hr (0.78R/mCi-hr) at 1 cm. The first half value layer is 0.017 cm of Pb. A range of values for the relative attenuation of the radiation emitted by this radionuclide that results from interposition of various thicknesses of Pb is shown in Table 4.0. To facilitate control of the radiation exposure from Megabequerel (millicurie) amounts of this radionuclide, the use of a 0.25 cm thickness of Pb will attenuate the radiation emitted by a factor of 1,000.

Table 4.0. Radiation Attenuation by Lead Shielding
Shield Thickness (Pb) cm Coefficient of Attenuation
0.017 0.5
0.08 10-1
0.16 10-2
0.25 10-3
0.33 10-4

To correct for physical decay of this radionuclide, the fractions that remain at selected intervals after the time of calibration are shown in Table 5.0.

Table 5.0 Physical Decay Chart; Tc99m Half-Life 6.02 Hours
Hours Fraction Remaining Hours Fraction Remaining
*
Calibration Time
0* 1.000 8 .398
1 .891 9 .355
2 .794 10 .316
3 .708 11 .282
4 .631 12 .251
5 .562
6 .501
7 .447

Kit For The Preparation Of Technetium Tc99m Sestamibi Manufacturers


  • Lantheus Medical Imaging, Inc.
    Kit For The Preparation Of Technetium Tc99m Sestamibi (Tetrakis(2-methoxyisobutylisocyanide)copper(I) Tetrafluoroborate) Injection, Powder, Lyophilized, For Solution [Lantheus Medical Imaging, Inc.]
  • Pharmalucence, Inc.
    Kit For The Preparation Of Technetium Tc99m Sestamibi (Technetium Tc-99m Sestamibi) Injection [Pharmalucence, Inc.]
  • Cardinal Health 414, Llc
    Kit For The Preparation Of Technetium Tc99m Sestamibi Injection, Powder, Lyophilized, For Solution [Cardinal Health 414, Llc]

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