TECHNETIUM TC 99M SESTAMIBI (technetium tc-99m sestamibi kit) · CURIUM
Technetium Tc 99m Sestamibi is a radioactive diagnostic agent indicated for myocardial perfusion imaging and breast imaging. In cardiac applications, it is used to detect coronary artery disease by localizing myocardial ischemia (reversible defects) and infarction (non-reversible defects), and to evaluate myocardial function during rest or stress tests. In breast imaging, it serves as a second-line diagnostic tool following mammography to assist in evaluating lesions in patients with abnormal mammograms or palpable masses. It is not indicated for breast cancer screening, to confirm or rule out malignancy, or as an alternative to biopsy.
How TECHNETIUM TC 99M SESTAMIBI Works
Technetium Tc 99m Sestamibi is a cationic complex that accumulates in viable myocardial tissue in a manner analogous to thallous chloride Tl-201. Evidence suggests that cellular retention in the heart occurs specifically within the mitochondria due to electrostatic interactions, allowing for scintigraphic visualization of perfusion defects. While its cardiac mechanism is well-characterized, the specific mechanism of Tc 99m Sestamibi localization in various types of breast tissue has not been established.
Details
- Status
- Prescription
- First Approved
- 2008-09-22
- Routes
- INJECTION
- Dosage Forms
- INJECTABLE
TECHNETIUM TC 99M SESTAMIBI Approval History
What TECHNETIUM TC 99M SESTAMIBI Treats
4 indicationsTECHNETIUM TC 99M SESTAMIBI is approved for 4 conditions since its original approval in 2008. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Coronary Artery Disease
- Myocardial Ischemia
- Myocardial Infarction
- Breast Lesions
TECHNETIUM TC 99M SESTAMIBI Competitive Set
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Indication competitors
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Trial Timeline
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Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
TECHNETIUM TC 99M SESTAMIBI FDA Label Details
Indications & Usage
Myocardial Imaging: Kit for the preparation of 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 agents labeling)...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.