CARDIOLITE (technetium tc-99m sestamibi kit)
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.
Drugs Similar to CARDIOLITE
3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
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 indicated for the treatment of Coronary Artery Disease; Myocardial Ischemia; Myocardial Infarction; Breast Lesions.
Track CARDIOLITE with TheraRadar Pro
Watchlist alerts, full database access, CSV exports across 14,000+ drugs.
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.