TETRAKIS(2-METHOXYISOBUTYLISOCYANIDE)COPPER(I) TETRAFLUOROBORATE

Other

Brand names: Cardiolite

Intravenous

Mechanism of Action

12.1 Mechanism of Action Technetium Tc99m Sestamibi is a cationic Tc99m complex which has been found to accumulate in viable myocardial tissue in a manner analogous to that of thallous chloride Tl-201. Scintigraphic images obtained in humans after the intravenous administration of the drug have been comparable to those obtained with thallous chloride Tl-201 in normal and abnormal myocardial tissue. Animal studies have shown that myocardial uptake is not blocked when the sodium pump mechanism is inhibited. Although studies of subcellular fractionation and electron micrographic analysis of heart cell aggregates suggest that Tc99m Sestamibi cellular retention occurs specifically within the mitochondria as a result of electrostatic interactions, the clinical relevance of these findings has not been determined. The mechanism of Tc99m Sestamibi localization in various types of breast tissue (e.g., benign, inflammatory, malignant, fibrous) has not been established.

Indications

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)

Kit for the Preparation of Technetium Tc99m Sestamibi for Injection

to confirm the presence or absence of malignancy

and it is not an alternative to biopsy.

Contraindications

• 4. CONTRAINDICATIONS None known. None known.

FDA Warnings

WARNINGS AND PRECAUTIONS Pharmacologic induction of cardiovascular stress may be associated with serious adverse events such as myocardial infarction, arrhythmia, hypotension, bronchoconstriction and cerebrovascular events
1 Warnings In studying patients in whom cardiac disease is known or suspected, care should be taken to assure continuous monitoring and treatment in accordance with safe, accepted clinical procedure
Infrequently, death has occurred 4 to 24 hours after Tc99m Sestamibi use and is usually associated with exercise stress testing (See Section 5
Pharmacologic induction of cardiovascular stress may be associated with serious adverse events such as myocardial infarction, arrhythmia, hypotension, bronchoconstriction and cerebrovascular events

Known Side Effects

13 documented side effects by frequency

Drug Not Working

>10%

Nausea

>10%

Rash

1-10%

Shortness of Breath

1-10%

Dizziness

1-10%

Headache

1-10%

Chest Pain

1-10%

Vomiting

0.1-1%

Cough

0.1-1%

Itching

0.1-1%

Anxiety

0.1-1%

General Unwellness

0.1-1%

Weakness

0.1-1%

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Formulations

Dosage Forms

Tablet

Route

Intravenous