Kit For The Preparation Of Technetium Tc99M Sestamibi

FDA Drug Information • Also known as: Kit For The Preparation Of Technetium Tc99M Sestamibi

Brand Names: Kit For The Preparation Of Technetium Tc99M Sestamibi
Drug Class: Radioactive Diagnostic Agent [EPC]
Route: PARENTERAL
Dosage Form: INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Product Type: HUMAN PRESCRIPTION DRUG

Description

11 DESCRIPTION Each 5 mL vial contains a sterile, non-pyrogenic, lyophilized mixture of:

Tetrakis (2-methoxy isobutyl isonitrile) Copper (I) tetrafluoroborate - 1.0 mg

Sodium Citrate Dihydrate - 2.6 mg

L-Cysteine Hydrochloride Monohydrate - 1.0 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 pH is 5.3 to 5.9. The contents of the vial are lyophilized and stored under nitrogen. This drug is administered by intravenous injection for diagnostic use after reconstitution with sterile, non-pyrogenic, oxidant-free Sodium Pertechnetate Tc 99m Injection. The pH of the reconstituted product is 5.5 (5.0–6.0). No bacteriostatic preservative is present. The precise structure of the technetium complex is Tc 99m[MIBI] 6 + where MIBI is 2-methoxy isobutyl isonitrile. Tetrakis (2-methoxy isobutyl isonitrile) Copper (I) tetrafluoroborate has the following structural formula: 11.1 Physical Characteristics Technetium Tc 99m decays by isomeric transition with a physical half-life of 6.02 hours 2 . Photons that are useful for detection and imaging studies are listed below in Table 3 . Table 3 Principal Radiation Emission Data Radiation Mean %/Disintegration Mean Energy (KeV) Gamma -2 89.07 140.5 2 Kocher, David, C., Radioactive Decay Data Tables, DOE/TIC-11026, 108(1981). 11.2 External Radiation The specific gamma ray constant for Tc 99m is 5.4 microcoulombs/Kg-MBq-hr (0.78R/mCi-hr) at 1 cm. The first half value layer is 0.017 cm of Pb. A range of values for the relative attenuation of the radiation emitted by this radionuclide that results from interposition of various thicknesses of Pb is shown in Table 4 . To facilitate control of the radiation exposure from Megabequerel (millicurie) amounts of this radionuclide, the use of a 0.25 cm thickness of Pb will attenuate...

What Is Kit For The Preparation Of Technetium Tc99M Sestamibi Used For?

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 agent indicated for: ( 1 )

detecting coronary artery disease by localizing myocardial ischemia (reversible defects) and infarction (non-reversible defects) ( 1 )

evaluating myocardial function and developing information for use in patient management decisions ( 1 )

Dosage and 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 breast should not be compressed on the overlay. For anterior images, position the patient supine with both arms behind the head. For either lateral or anterior images, shield the chest and abdominal organs, or remove them from the field of view. For complete study, sets of images should be obtained five minutes after the injection, and in the following sequence: Beginning five minutes after the injection of Technetium Tc 99m Sestamibi:

ten-minute lateral image of breast with abnormality

ten-minute lateral image of contralateral breast

ten-minute anterior image of both breasts 2.2 Radiation Dosimetry The radiation doses to organs and tissues of an average patient (70 Kg) per 1110 MBq (30 mCi) of Technetium Tc 99m Sestamibi injected intravenously are shown in Table 1 . Table 1 Radiation Absorbed Doses from Tc 99m Sestamibi Estimated Radiation Absorbed Dose REST 2.0 hour void 4.8 hour void Organ rads/30 mCi mGy/1110 MBq rads/30 mCi mGy/1110 MBq Breasts 0.2 2.0 0.2 1.9 Gallbladder Wall 2.0 20.0 2.0 20.0 Small Intestine 3.0 30.0 3.0 30.0 Upper Large Intestine Wall 5.4 55.5 5.4 55.5 Lower Large Intestine Wall 3.9 40.0 4.2 41.1 Stomach Wall 0.6 6.1 0.6 5.8 Heart Wall 0.5 5.1 0.5 4.9 Kidneys 2.0 20.0 2.0 20.0 Liver 0.6 5.8 0.6 5.7 Lungs 0.3 2.8 0.3 2.7 Bone Surfaces 0.7 6.8 0.7 6.4 Thyroid 0.7 7.0 0.7 2.4 Ovaries 1.5 15.5 1.6 15.5 Testes 0.3 3.4 0.4 3.9 Red Marrow 0.5 5.1 0.5 5.0 Urinary Bladder Wall 2.0 20.0 4.2 41.1 Total Body 0.5 4.8 0.5 4.8 STRESS 2.0 hour void 4.8 hour void Organ rads/30 mCi mGy/1110 MBq rads/30 mCi mGy/1110 MBq Breasts 0.2 2.0 0.2 1.8 Gallbladder Wall 2.8 28.9 2.8 27.8 Small Intestine 2.4 24.4 2.4 24.4 Upper Large Intestine Wall 4.5 44.4 4.5 44.4 Lower Large Intestine Wall 3.3 32.2 3.3 32.2 Stomach Wall 0.6 5.3 0.5 5.2 Heart Wall 0.5 5.6 0.5 5.3...

Side Effects (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 Senses 132 (19.6%) 62 (9.1%) 160 (6.8%) 222 (7.3%) Taste Perversion 129 (19.2%) 60 (8.8%) 157 (6.6%) 217 (7.1%) Parosmia 8 (1.2%) 6 (0.9%) 10 (0.4%) 16 (0.5%) 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. The following adverse reactions have been reported in ≤ 0.5% of patients: signs and symptoms consistent with seizure occurring shortly after administration of the agent; transient arthritis; angioedema, arrhythmia, dizziness, syncope, abdominal pain, vomiting, and severe hypersensitivity characterized by dyspnea, hypotension, bradycardia, asthenia, and vomiting within two hours after a second injection of Technetium Tc 99m Sestamibi. A few cases of flushing, edema, injection site inflammation, dry mouth, fever, pruritus, rash, urticaria and fatigue have also been attributed to administration of the agent. The following adverse reactions have been reported in ≤ 0.5% of patients: signs and symptoms consistent with seizure occurring shortly after administration of the agent; transient arthritis; angioedema, arrhythmia, dizziness, syncope, abdominal pain, vomiting, and severe hypersensitivity characterized by dyspnea, hypotension, bradycardia, asthenia, and vomiting within two hours after a second injection of Technetium Tc 99m Sestamibi. A few cases of flushing, edema, injection site inflammation, dry mouth, fever, pruritus, rash, urticaria and fatigue have also been attributed to administration of the agent ( 6 ). To report SUSPECTED ADVERSE REACTIONS, contact Cardinal Health at 1-800-618-2768 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Warnings and Precautions

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 available when administering Technetium Tc 99m Sestamibi. Also, before administering Technetium Tc 99m Sestamibi Injection, patients should be asked about the possibility of allergic reactions to the drug.

Drug Interactions

7 DRUG INTERACTIONS Specific drug-drug interactions have not been studied.

Specific drug-drug interactions have not been studied ( 7 ).

Contraindications

4 CONTRAINDICATIONS None known.

None known. ( 4 )

Pregnancy and Breastfeeding

8.1 Pregnancy Animal reproduction and teratogenicity studies have not been conducted with Technetium Tc 99m Sestamibi. It is also not known whether Technetium Tc 99m Sestamibi can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity. There have been no studies in pregnant women. Technetium Tc 99m Sestamibi should be given to a pregnant woman only if clearly needed.

8.3 Nursing Mothers Technetium Tc 99m Pertechnetate is excreted in human milk during lactation. It is not known whether Technetium Tc 99m Sestamibi is excreted in human milk. Therefore, formula feedings should be substituted for breast feedings.

Overdosage

10 OVERDOSAGE The clinical consequences of overdosing with Technetium Tc 99m Sestamibi are not known.

How Supplied

16 HOW SUPPLIED/STORAGE AND HANDLING Kit for Preparation of Technetium Tc 99m Sestamibi Injection is supplied as a 5 mL vial in kits of twenty (20) vials (NDC # 65857-500-20), sterile and non-pyrogenic. The patient dose should be measured by a suitable radioactivity calibration system immediately prior to patient administration. Radiochemical purity should be checked prior to patient administration. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit. Prior to lyophilization the pH is between 5.3-5.9. The contents of the vial are lyophilized and stored under nitrogen. Store at 15-25°C (59-77°F) before and after reconstitution. Kit for Preparation of Technetium Tc 99m Sestamibi Injection contains no preservatives. Included in each twenty (20) vial kit is one (1) package insert, twenty-four (24) vial shield labels and twenty-four (24) radiation warning labels. This reagent kit is approved for distribution to persons licensed by the U.S. Nuclear Regulatory Commission to use byproduct material identified in 10 CFR 35.200 or under an equivalent license issued by an Agreement State or Licensing State.

About This Information

This drug information is sourced from FDA-approved labeling via the openFDA database. It is intended for educational and reference purposes only. This is not medical advice. Always consult your healthcare provider before making decisions about medication. Drug information may be updated by the FDA; check with your pharmacist for the most current information.

What are side effects?

Side effects are unwanted reactions that can occur when taking a medication. They range from mild (headache, nausea) to severe (allergic reactions, organ damage). Not everyone experiences side effects, and severity varies. Report any concerning side effects to your doctor.

What are drug interactions?

Drug interactions occur when a medication is affected by another drug, food, or supplement. Interactions can make medications less effective or cause dangerous side effects. Always tell your doctor about all medications and supplements you take.