Technetium Tc 99m Sestamibi
Generic Name: technetium tc 99m sestamibi
Brand Names:
Technetium Tc 99m Sestamibi
11. DESCRIPTION Each 10 mL vial contains a sterile, non-pyrogenic, lyophilized mixture of: Tetrakis (2-methoxy isobutyl isonitrile) Copper (I) tetrafluoroborate – 1 mg Sodium Citrate Dihydrate - 2.6 mg L-Cysteine Hydrochloride Monohydrate – 1 mg Mannitol - 20 mg Stannous Chloride, Dihydrate, minimum (SnCl 2 •2H 2 O) - 0.025 mg Stannous Chloride, Dihydrate (SnCl 2 •2H 2 O) - 0.075 mg Tin Chloride (stannous and stannic) Dihydrate, maximum (as SnCl 2 •2H 2 O) - 0.086 mg Prior to lyophilization the...
Overview
11. DESCRIPTION Each 10 mL vial contains a sterile, non-pyrogenic, lyophilized mixture of: Tetrakis (2-methoxy isobutyl isonitrile) Copper (I) tetrafluoroborate – 1 mg Sodium Citrate Dihydrate - 2.6 mg L-Cysteine Hydrochloride Monohydrate – 1 mg Mannitol - 20 mg Stannous Chloride, Dihydrate, minimum (SnCl 2 •2H 2 O) - 0.025 mg Stannous Chloride, Dihydrate (SnCl 2 •2H 2 O) - 0.075 mg Tin Chloride (stannous and stannic) Dihydrate, maximum (as SnCl 2 •2H 2 O) - 0.086 mg Prior to lyophilization the...
Uses
1. INDICATIONS AND USAGE Myocardial Imaging: Kit for the Preparation of Technetium Tc99m 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 Tc99m 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.
Dosage
2. DOSAGE AND ADMINISTRATION For Myocardial Imaging: The suggested dose range for I.V. administration of Technetium Tc99m 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 Tc99m Sestamibi is a single dose of 740–1110 MBq (20–30 mCi). For Myocardial Imaging: The suggested dose range for I.V. administration of Technetium Tc99m 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 Tc99m Sestamibi is a single dose of 740-1110 MBq (20-30 mCi).
Side Effects
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 Section 5 ). Adverse events reported at a rate of 0.5% or greater after receiving Technetium Tc99m Sestamibi administration are shown in the following table: In the clinical studies for breast imaging, breast pain was reported in 12 (1.7%) of the patients. In 11 of these patients the pain appears to be associated with biopsy/surgical procedures.
Interactions
7. DRUG INTERACTIONS Specific drug-drug interactions have not been studied. Specific drug-drug interactions have not been studied.
Warnings
5. 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. Technetium Tc99m 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 Technetium Tc99m Sestamibi imaging. Caution should be exercised and emergency equipment should be available when administering Technetium Tc99m Sestamibi. Before administering Technetium Tc99m Sestamibi patients should be asked about the possibility of allergic reactions to either drug. 4. CONTRAINDICATIONS None known. None known.
Pregnancy
8.1 Pregnancy Risk Summary Limited available data with Technetium Tc99m Sestamibi use in pregnant women have not identified a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. Animal reproduction and teratogenicity studies have not been conducted with Technetium Tc99m Sestamibi. However, all radiopharmaceuticals have the potential to cause fetal harm depending on the fetal stage of development and the magnitude of the radiation dose.
Storage
16. HOW SUPPLIED/STORAGE AND HANDLING Kit for the Preparation of Technetium Tc99m Sestamibi Injection is supplied as a 10 mL vial in kits of five (5) (NDC # 69945-092-20) or a carton of thirty (30) (NDC # 69945-092-40), sterile and non-pyrogenic. The patient dose should be measured by a suitable radioactivity calibration system immediately prior to patient administration.
Frequently Asked Questions
What is Technetium Tc 99m Sestamibi used for?▼
1. INDICATIONS AND USAGE Myocardial Imaging: Kit for the Preparation of Technetium Tc99m 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 Tc99m 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.
What are the side effects of Technetium Tc 99m Sestamibi?▼
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 Section 5 ). Adverse events reported at a rate of 0.5% or greater after receiving Technetium Tc99m Sestamibi administration are shown in the following table: In the clinical studies for breast imaging, breast pain was reported in 12 (1.7%) of the patients. In 11 of these patients the pain appears to be associated with biopsy/surgical procedures.
Can I take Technetium Tc 99m Sestamibi during pregnancy?▼
8.1 Pregnancy Risk Summary Limited available data with Technetium Tc99m Sestamibi use in pregnant women have not identified a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. Animal reproduction and teratogenicity studies have not been conducted with Technetium Tc99m Sestamibi. However, all radiopharmaceuticals have the potential to cause fetal harm depending on the fetal stage of development and the magnitude of the radiation dose.
What are the important warnings for Technetium Tc 99m Sestamibi?▼
5. 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. Technetium Tc99m 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 Technetium Tc99m Sestamibi imaging. Caution should be exercised and emergency equipment should be available when administering Technetium Tc99m Sestamibi. Before administering Technetium Tc99m Sestamibi patients should be asked about the possibility of allergic reactions to either drug. 4. CONTRAINDICATIONS None known. None known.
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Medical Disclaimer
This drug information is for educational purposes only and should not replace professional medical advice. Drug information is sourced from the FDA National Drug Code Directory and Structured Product Labeling. Always consult with a healthcare provider before starting, stopping, or changing any medication.