Kit for the Preparation of Technetium Tc99m Sestamibi 1 mg/mL
TETRAKIS(2-METHOXYISOBUTYLISOCYANIDE)COPPER(I) TETRAFLUOROBORATE · INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION · Lantheus Medical Imaging, Inc.
Kit for the Preparation of Technetium Tc99m Sestamibi is a injection, powder, lyophilized, for solution containing tetrakis(2-methoxyisobutylisocyanide)copper(i) tetrafluoroborate at 1 mg/mL, taken intravenous. Manufactured by Lantheus Medical Imaging, Inc..
Key Facts
- Brand Name
- Kit for the Preparation of Technetium Tc99m Sestamibi
- Generic Name
- TETRAKIS(2-METHOXYISOBUTYLISOCYANIDE)COPPER(I) TETRAFLUOROBORATE
- NDC Code (Product)
11994-003- Manufacturer
- Lantheus Medical Imaging, Inc.
- Strength
- 1 mg/mL
- Dosage Form
- INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
- Route
- INTRAVENOUS
- Marketing Status
- Application #
- NDA019785
- Marketing Start
- 12/20/1990
Recall History
No Recall HistorySide Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
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. Technetium Tc 99m Sestamibi is a myocardial perfusion ag…
Dosage & Administration
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). ( 2 ) • 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 ) 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…
Warnings
5.1 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 Tc 99m Sestamibi use and is usually associated with exercise stress testing [ see Warnings and Precautions ( 5.2 ) ]. Pharmacologic induction of cardiovascular stress may be associated with serious adverse events such as myocardial infarction, arrhythmia, hypotension, bronchoconstriction and cerebrovascular events. Caution should be used when pharmacologic stress is selected as an alternative to exercise; it should be used when indicated and in accordance with the pharmacologic stress agent’s labeling. Technetium Tc 99m Sestamibi has been rarely associated with acute severe allergic and anaphylactic events of angioedema and generalized urticaria. In some patients the allergic symptoms developed on the second injection during Tc 99m Sestamibi imaging. Patients who receive Technetium Tc 99m Sestamibi for either myocardial or breast imaging are receiving the same drug. Caution should be exercised and emergency equipment should be avai…
Contraindications
4 CONTRAINDICATIONS None known. • None known. ( 4 )
Drug Interactions
7 DRUG INTERACTIONS Specific drug-drug interactions have not been studied. • Specific drug-drug interactions have not been studied ( 7 ).
Adverse Reactions
6 ADVERSE REACTIONS Adverse events were evaluated in 3741 adults who were evaluated in clinical studies. Of these patients, 3068 (77% men, 22% women, and 0.7% of the patients’ genders were not recorded) were in cardiac clinical trials and 673 (100% women) in breast imaging trials. Cases of angina, chest pain, and death have occurred [ see Warnings and Precautions ( 5 ) ]. Adverse events reported at a rate of 0.5% or greater after receiving Technetium Tc 99m Sestamibi administration are shown in the following table: Table 2 Selected Adverse Events Reported in > 0.5% of Patients Who Received Technetium Tc 99m Sestamibi in Either Breast or Cardiac Clinical Studies Excludes the 22 patients whose genders were not recorded. Body System Breast Studies Cardiac Studies Women Women Men Total n = 673 n = 685 n = 2361 n = 3046 Body as a Whole 21 (3.1%) 6 (0.9%) 17 (0.7%) 23 (0.8%) Headache 11 (1.6%) 2 (0.3%) 4 (0.2%) 6 (0.2%) Cardiovascular 9 (1.3%) 24 (3.5%) 75 (3.2%) 99 (3.3%) Chest Pain/Angina 0 (0%) 18 (2.6%) 46 (1.9%) 64 (2.1%) ST segment changes 0 (0%) 11 (1.6%) 29 (1.2%) 40 (1.3%) Digestive System 8 (1.2%) 4 (0.6%) 9 (0.4%) 13 (0.4%) Nausea 4 (0.6%) 1 (0.1%) 2 (0.1%) 3 (0.1%) Special Se…
Frequently Asked Questions
What is Kit for the Preparation of Technetium Tc99m Sestamibi used for?
Kit for the Preparation of Technetium Tc99m Sestamibi contains TETRAKIS(2-METHOXYISOBUTYLISOCYANIDE)COPPER(I) TETRAFLUOROBORATE. It is a injection, powder, lyophilized, for solution taken intravenous. Consult your doctor for specific uses.
Is Kit for the Preparation of Technetium Tc99m Sestamibi a controlled substance?
Kit for the Preparation of Technetium Tc99m Sestamibi is not classified as a controlled substance by the DEA.
What is the generic name for Kit for the Preparation of Technetium Tc99m Sestamibi?
The generic name for Kit for the Preparation of Technetium Tc99m Sestamibi is TETRAKIS(2-METHOXYISOBUTYLISOCYANIDE)COPPER(I) TETRAFLUOROBORATE. There are 1 other brand versions of TETRAKIS(2-METHOXYISOBUTYLISOCYANIDE)COPPER(I) TETRAFLUOROBORATE.
What is the NDC code for Kit for the Preparation of Technetium Tc99m Sestamibi 1 mg/mL?
The NDC (National Drug Code) for Kit for the Preparation of Technetium Tc99m Sestamibi 1 mg/mL is 11994-003, listed by Lantheus Medical Imaging, Inc..