Kit For the Preparation of Technetium Tc 99m Sestamibi

KIT FOR THE PREPARATION OF TECHNETIUM TC 99M SESTAMIBI- tetrakis(2-methoxyisobutylisocyanide)copper(i) tetrafluoroborate injection
Mallinckrodt Inc.

1 INDICATIONS AND USAGE

Myocardial Imaging: Technetium Tc 99m Sestamibi Injection 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 Tc 99m 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 Tc 99m 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 Tc 99m Sestamibi is not indicated for breast cancer screening, to confirm the presence or absence of malignancy, and it is not an alternative to biopsy.

2 DOSAGE AND ADMINISTRATION

For Myocardial Imaging: The suggested dose range for I.V. administration of Technetium Tc 99m Sestamibi in a single dose to be employed in the average patient (70 Kg) is 370–1110 MBq (10–30 mCi).

For Breast Imaging: The recommended dose range for I.V. administration of Technetium Tc 99m Sestamibi is a single dose of 740–1110 MBq (20–30 mCi).

2.1 Image Acquisition

Breast Imaging: It is recommended that images are obtained with a table overlay to separate breast tissue from the myocardium and liver, and to exclude potential activity that may be present in the opposite breast. For lateral images, position the patient prone with the isolateral arm comfortably above the head, shoulders flat against the table, head turned to the side and relaxed, with the breast imaged pendent through an overlay cutout. The breast should not be compressed on the overlay. For anterior images, position the patient supine with both arms behind the head. For either lateral or anterior images, shield the chest and abdominal organs, or remove them from the field of view.

For complete study, sets of images should be obtained five minutes after the injection, and in the following sequence:

Beginning five minutes after the injection of Technetium Tc 99m Sestamibi:

  • ten-minute lateral image of breast with abnormality
  • ten-minute lateral image of contralateral breast
  • ten-minute anterior image of both breasts

2.2 Radiation Dosimetry

The radiation doses to organs and tissues of an average patient (70 Kg) per 1110 MBq (30 mCi) of Technetium Tc 99m Sestamibi injected intravenously are shown in Table 1.

Table 1. Radiation Absorbed Doses from Tc 99m Sestamibi

Radiation dosimetry calculations performed by Radiation Internal Dose Information Center, Oak Ridge Institute for Science and Education, PO Box 117, Oak Ridge, TN 37831-0117, (865) 576-3448.

Estimated Radiation Absorbed Dose
REST
2.0 hour void 4.8 hour void
Organ rads/30 mCi mGy/1110 MBq rads/30 mCi mGy/1110 MBq
Breasts 0.2 2.0 0.2 1.9
Gallbladder Wall 2.0 20.0 2.0 20.0
Small Intestine 3.0 30.0 3.0 30.0
Upper LargeIntestine Wall 5.4 55.5 5.4 55.5
Lower LargeIntestine Wall 3.9 40.0 4.2 41.1
Stomach Wall 0.6 6.1 0.6 5.8
Heart Wall 0.5 5.1 0.5 4.9
Kidneys 2.0 20.0 2.0 20.0
Liver 0.6 5.8 0.6 5.7
Lungs 0.3 2.8 0.3 2.7
Bone Surfaces 0.7 6.8 0.7 6.4
Thyroid 0.7 7.0 0.7 2.4
Ovaries 1.5 15.5 1.6 15.5
Testes 0.3 3.4 0.4 3.9
Red Marrow 0.5 5.1 0.5 5.0
Urinary Bladder Wall 2.0 20.0 4.2 41.1
Total Body 0.5 4.8 0.5 4.8
Estimated Radiation Absorbed Dose
STRESS
2.0 hour void 4.8 hour void
Organ rads/30 mCi mGy/1110 MBq rads/30 mCi mGy/1110 MBq
Breasts 0.2 2.0 0.2 1.8
Gallbladder Wall 2.8 28.9 2.8 27.8
Small Intestine 2.4 24.4 2.4 24.4
Upper LargeIntestine Wall 4.5 44.4 4.5 44.4
Lower LargeIntestine Wall 3.3 32.2 3.3 32.2
Stomach Wall 0.6 5.3 0.5 5.2
Heart Wall 0.5 5.6 0.5 5.3
Kidneys 1.7 16.7 1.7 16.7
Liver 0.4 4.2 0.4 4.1
Lungs 0.3 2.6 0.2 2.4
Bone Surfaces 0.6 6.2 0.6 6.0
Thyroid 0.3 2.7 0.2 2.4
Ovaries 1.2 12.2 1.3 13.3
Testes 0.3 3.1 0.3 3.4
Red Marrow 0.5 4.6 0.5 4.4
Urinary Bladder Wall 1.5 15.5 3.0 30.0
Total Body 0.4 4.2 0.4 4.2

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