Technetium Tc 99m Sestamibi 1 mg/mL
Technetium Tc 99m Sestamibi · INJECTION · Curium US LLC
Technetium Tc 99m Sestamibi is a injection containing technetium tc 99m sestamibi at 1 mg/mL, taken intravenous. Manufactured by Curium US LLC.
Key Facts
- Brand Name
- Technetium Tc 99m Sestamibi
- Generic Name
- Technetium Tc 99m Sestamibi
- NDC Code (Product)
69945-092- Manufacturer
- Curium US LLC
- Strength
- 1 mg/mL
- Dosage Form
- INJECTION
- Route
- INTRAVENOUS
- Marketing Status
- Application #
- ANDA078098
- Marketing Start
- 10/31/2011
Recall History
Curium US, LLC
Lack of Assurance of Sterility; Improper crimps on vials impacting the integrity of the product
Pharmalucence, Inc.
Presence of Particulate Matter; particulate found in retain samples
Side 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: 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). It is usually not possible to determine the age of a myocardial infarction or to differentiate a recent myocardial infarction from ischemia. Breast Imaging: Kit for the preparation of Technetium Tc 99m Sestamibi Injection 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. Kit for the preparation of Technetium Tc 99m Sestamibi Injection is not indicated for breast cancer screening, to confirm the presence or absence of malignan…
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 to 1110 MBq (10 to 30 mCi). For Breast Imaging: The recommended dose range for I.V. administration of Technetium Tc 99m Sestamibi is a single dose of 740 to 1110 MBq (20 to 30 mCi). 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 to 1110 MBq (10 to 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 to 1110 MBq (20 to 30 mCi) ( 2 ). 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…
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 General 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 available…
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 Warning and Precautions ( 5.1 ) ]. 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* Body System Breast Studies Cardiac Studies Women n = 673 Women n = 685 Men n = 2361 Total 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 Senses 132 (19.6 %) 62 (9.1…
Frequently Asked Questions
What is Technetium Tc 99m Sestamibi used for?
Technetium Tc 99m Sestamibi contains Technetium Tc 99m Sestamibi. It is a injection taken intravenous. Consult your doctor for specific uses.
Is Technetium Tc 99m Sestamibi a controlled substance?
Technetium Tc 99m Sestamibi is not classified as a controlled substance by the DEA.
What is the generic name for Technetium Tc 99m Sestamibi?
The generic name for Technetium Tc 99m Sestamibi is Technetium Tc 99m Sestamibi. There are 1 other brand versions of Technetium Tc 99m Sestamibi.
What is the NDC code for Technetium Tc 99m Sestamibi 1 mg/mL?
The NDC (National Drug Code) for Technetium Tc 99m Sestamibi 1 mg/mL is 69945-092, listed by Curium US LLC.