CARDIOLITE (technetium tc-99m sestamibi kit) · SHINE
Cardiolite is a myocardial perfusion imaging agent indicated for the detection of coronary artery disease (CAD) by localizing myocardial ischemia (reversible defects) and infarction (non-reversible defects). It is used to evaluate myocardial function and guide patient management decisions. Additionally, it is indicated for breast imaging as a second-line diagnostic tool following mammography to evaluate suspicious lesions or palpable masses. It is important to note that it is not indicated for breast cancer screening, to confirm the presence or absence of malignancy, or as an alternative to biopsy.
How CARDIOLITE Works
Technetium Tc-99m Sestamibi is a cationic complex that accumulates in viable myocardial tissue in a manner proportional to regional blood flow. Cellular retention is thought to occur specifically within the mitochondria via electrostatic interactions, allowing clinicians to distinguish healthy, viable muscle from ischemic or infarcted areas. While used in breast imaging, the specific mechanism of localization in various types of breast tissue has not been established.
Details
- Status
- Prescription
- First Approved
- 1990-12-21
- Routes
- INJECTION
- Dosage Forms
- INJECTABLE
CARDIOLITE Approval History
What CARDIOLITE Treats
4 indicationsCARDIOLITE is approved for 4 conditions since its original approval in 1990. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Coronary Artery Disease
- Myocardial Ischemia
- Myocardial Infarction
- Breast Lesions
CARDIOLITE Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
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Active Pipeline
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Key Completed Trials
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Trial Timeline
Full development history with FDA approval milestones
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.
CARDIOLITE FDA Label Details
Indications & Usage
FDA Label (PDF)CARDIOLITE® is a myocardial perfusion agent indicated for: detecting coronary artery disease by localizing myocardial ischemia (reversible defects) and infarction (non-reversible defects) evaluating myocardial function and developing information for use in patient management decisions Myocardial Imaging: CARDIOLITE ® , Kit for the Preparation of Technetium Tc99m Sestamibi for 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 f...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.