Cardiolite TETRAKIS(2-METHOXYISOBUTYLISOCYANIDE)COPPER(I) TETRAFLUOROBORATE 1 mg/mL Injection, Powder, Lyophilized, For Solution
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🧪 Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
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1 mg / 1 mL
UNII ZT934N0X4W
A naturally occurring amino acid salt used as a reducing agent and antioxidant in medications. It helps prevent ingredient breakdown and may improve product stability during storage.
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20 mg / 1 mL
UNII 3OWL53L36A
A natural sugar alcohol derived from seaweed or synthesized in the lab. It's used as a filler to add bulk, a sweetener in sugar-free formulas, and a disintegrant to help tablets break apart in the stomach.
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0.075 mg / 1 mL
UNII 1BQV3749L5
Stannous chloride is a tin-based chemical compound used as a reducing agent and antioxidant in pharmaceuticals. It helps prevent oxidation of active ingredients and stabilizes certain formulations, particularly in products requiring preservation of potency.
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2.6 mg / 1 mL
UNII B22547B95K
A salt derived from citric acid that helps maintain the proper acid-base balance in the medicine. It's used as a buffer to keep the product stable and at the right pH level.
4 inactive ingredients listed in the exact product block matched to this NDC.
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ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.Inactive ingredient FAQ
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| Price system | Per mL | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | Not in the retail survey — common for institutional, discontinued, or low-volume packs. | |
| Medicaid paysCMS SDUD · 12 mo | No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data. | |
| Medicare drug plans payPart D · quarterly | No Part D plan price is available for this NDC in our data. | |
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🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Kit for the Preparation of Technetium Tc99m Sestamibi 1 mg/mL 11994-0003-20 | Lantheus | 20 vials | — | AP | FDA listed | — |
| Cardiolite 1 mg/mL 11994-0001-20 | Lantheus | 20 vials | — | AP | FDA listed | — |
| Cardiolite 1 mg/mLthis 87333-0001-55 | SHINE | 5 vials | — | AP | FDA listed | — |
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📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 87333-0001-20 | 20 VIAL in 1 BOX (87333-001-20) / 5 mL in 1 VIAL | 2026-09-10 | Active |
| 87333-0001-55 You're viewing this | 5 VIAL in 1 BOX (87333-001-55) / 5 mL in 1 VIAL | 2026-09-10 | Active |
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| NDC identity (package / product / labeler codes) | ✓ Available |
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| Product & package description | ✓ Available |
| Marketing category & status | ✓ Available |
| Active ingredient / dosage form / route | ✓ Available |
| FDA label (SPL via DailyMed) | ✓ Available |
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| Inactive ingredients (structured) | ✓ Available |
| NADAC pharmacy acquisition price (CMS) | — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey. |
| Orange Book / therapeutic-equivalence data | ✓ Available |
| HCPCS J-code billing crosswalk | — Not published for this NDC Most self-administered / retail products have no J-code — that is normal. |
| Medicaid utilization (CMS SDUD) | — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold. |
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📄 Full prescribing information FDA SPL
🎯 Indications and Usage ▾
1. INDICATIONS AND USAGE CARDIOLITE® is a myocardial perfusion agent indicated for: detecting coronary artery disease by localizing myocardial ischemia (reversible defects) and infarction (non-reversible defects) evaluating myocardial function and developing information for use in patient management decisions Myocardial Imaging: CARDIOLITE ® 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), in evaluating myocardial function and developing information for use in patient management decisions.
CARDIOLITE ® 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: MIRALUMA ® , Kit for the Preparation of Technetium Tc99m Sestamibi for 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.
MIRALUMA ® is not indicated for breast cancer screening, to confirm the presence or absence of malignancy, and it is not an alternative to biopsy.
⏱️ Dosage and Administration ▾
2. DOSAGE AND ADMINISTRATION For Myocardial Imaging: The suggested dose range for I.V. administration of CARDIOLITE® 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 MIRALUMA® is a single dose of 740 - 1110 MBq (20 - 30 mCi).
For Myocardial Imaging: The suggested dose range for I.V. administration of CARDIOLITE® 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 MIRALUMA® is a single dose of 740 - 1110 MBq (20 - 30 mCi).
2.1Image 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 Tc99m Sestamibi: ten-minute lateral image of breast with abnormality ten-minute lateral image of contralateral breast ten-minute anterior image of both breasts
2.2Radiation Dosimetry The radiation doses to organs and tissues of an average patient (70 Kg) per 1110 MBq (30 mCi) of Technetium Tc99m Sestamibi injected intravenously are shown in Table 1.0. Table 1.0. Radiation Absorbed Doses from Tc99m Sestamibi Estimated Radiation Absorbed Dose Radiation dosimetry calculations performed by Radiation Internal Dose Information Center, Oak Ridge Institute for Science and Education, PO Box 117, Oak Ridge, TN 37831-0117.
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
1.9Gallbladder Wall 2.0 20.0 2.0
20.0Small Intestine 3.0 30.0 3.0
30.0Upper Large Intestine Wall 5.4 55.5 5.4
55.5Lower Large Intestine Wall 3.9 40.0 4.2
41.1Stomach Wall 0.6 6.1 0.6
5.8Heart Wall 0.5 5.1 0.5
4.9Kidneys 2.0 20.0 2.0
20.0Liver 0.6 5.8 0.6
5.7Lungs 0.3 2.8 0.3
2.7Bone Surfaces 0.7 6.8 0.7
6.4Thyroid 0.7 7.0 0.7
7.0Ovaries 1.5 15.5 1.6
15.5Testes 0.3 3.4 0.4
3.9Red Marrow 0.5 5.1 0.5
5.0Urinary Bladder Wall 2.0 20.0 4.2
41.1Total Body 0.5 4.8 0.5
4.8STRESS 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
1.8Gallbladder Wall 2.8 28.9 2.8
27.8Small Intestine 2.4 24.4 2.4
24.4Upper Large Intestine Wall 4.5 44.4 4.5
44.4Lower Large Intestine Wall 3.3 32.2 3.3
32.2Stomach Wall 0.6 5.3 0.5
5.2Heart Wall 0.5 5.6 0.5
5.3Kidneys 1.7 16.7 1.7
16.7Liver 0.4 4.2 0.4
4.1Lungs 0.3 2.6 0.2
2.4Bone Surfaces 0.6 6.2 0.6
6.0Thyroid 0.3 2.7 0.2
2.4Ovaries 1.2 12.2 1.3
13.3Testes 0.3 3.1 0.3
3.4Red Marrow 0.5 4.6 0.5
4.4Urinary Bladder Wall 1.5 15.5 3.0
30.0Total Body 0.4 4.2 0.4 4.2
2.3Instructions For Preparation Preparation of the Technetium Tc99m Sestamibi from the Kit for the Preparation of Technetium Tc99m Sestamibi is done by the following aseptic procedure: General Procedure: a.Prior to adding the Sodium Pertechnetate Tc99m Injection to the vial, inspect the vial carefully for the presence of damage, particularly cracks, and do not use the vial if found. Tear off a radiation symbol and attach it to the neck of the vial. b.Waterproof gloves should be worn during the preparation procedure.
Remove the plastic disc from the vial and swab the top of the vial closure with alcohol to sanitize th…
💊 Dosage Forms and Strengths ▾
3. DOSAGE FORMS AND STRENGTHS CARDIOLITE ®, Kit for the Preparation of Technetium Tc99m Sestamibi for Injection is supplied as a lyophilized mixture in a 5 mL vial. CARDIOLITE ® , Kit for the Preparation of Technetium Tc99m Sestamibi for Injection is supplied as a lyophilized mixture in a 5 mL vial.
⛔ Contraindications ▾
4. CONTRAINDICATIONS None known. None known.
⚠️ Warnings and Cautions ▾
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. CARDIOLITE® 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 CARDIOLITE® imaging. Caution should be exercised and emergency equipment should be available when administering CARDIOLITE®. Before administering CARDIOLITE® patients should be asked about the possibility of allergic reactions to either drug.
The contents of the vial are intended only for use in the preparation of Technetium Tc99m Sestamibi and are not to be administered directly to the patient without first undergoing the preparative procedure.
5.1Warnings 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 5.2 ). 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 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 CARDIOLITE® imaging.
Patients who receive CARDIOLITE® or MIRALUMA® imaging are receiving the same drug. Caution should be exercised and emergency equipment should be available when administering Technetium Tc99m Sestamibi. Also, before administering either CARDIOLITE® or MIRALUMA®, patients should be asked about the possibility of allergic reactions to either drug.
5.2General Precautions The contents of the vial are intended only for use in the preparation of Technetium Tc99m Sestamibi and are not to be administered directly to the patient without first undergoing the preparative procedure. Radioactive drugs must be handled with care and appropriate safety measures should be used to minimize radiation exposure to clinical personnel. Also, care should be taken to minimize radiation exposure to the patients consistent with proper patient management.
Contents of the kit before preparation are not radioactive. However, after the Sodium Pertechnetate Tc99m Injection is added, adequate shielding of the final preparation must be maintained. The components of the kit are sterile and non-pyrogenic.
It is essential to follow directions carefully and to adhere to strict aseptic procedures during preparation. Technetium Tc99m labeling reactions depend on maintaining the stannous ion in the reduced state. Hence, Sodium Pertechnetate Tc99m Injection containing oxidants should not be used.
Technetium Tc99m Sestamibi should not be used more than six hours after preparation. Radiopharmaceuticals should be used only by physicians who are qualified by training and experience in the safe use and handling of radionuclides and whose experience and training have been approved by the appropriate government agency authorized to license the use of radionuclides. Stress testing should be performed only under the supervision of a qualified physician and in a laboratory equipped with appropriate resuscitation and support apparatus.
The most frequent exercise stress test endpoints sufficient to stop the test reported during controlled studies (two-thirds were cardiac patients) were: Fatigue 35% Dyspnea 17% Chest Pain 16% ST-depression 7%…
⚠️ Warnings ▾
5.1Warnings 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 5.2 ). 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 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 CARDIOLITE® imaging.
Patients who receive CARDIOLITE® or MIRALUMA® imaging are receiving the same drug. Caution should be exercised and emergency equipment should be available when administering Technetium Tc99m Sestamibi. Also, before administering either CARDIOLITE® or MIRALUMA®, patients should be asked about the possibility of allergic reactions to either drug.
🤒 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 patient's 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: Table
2.0Selected Adverse Events Reported in > 0.5% of Patients Who Received Technetium Tc99m 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%) 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%) *Excludes the 22 patients whose gender was not recorded.
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, arrythmia, 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 Tc99m Sestamibi.
A few cases of flushing, edema, injection site inflammation, dry mouth, fever, pruritis, 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, arrythmia, 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 Tc99m Sestamibi.
A few cases of flushing, edema, injection site inflammation, dry mouth, fever, pruritis, rash, urticaria and fatigue have also been attributed to administration of the agent. To report SUSPECTED ADVERSE REACTIONS, contact SHINE SPECT USA, LLC at 1-800-657-5426 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
🔄 Drug Interactions ▾
7. DRUG INTERACTIONS Specific drug-drug interactions have not been studied. Specific drug-drug interactions have not been studied.
👥 Use in Specific Populations ▾
8. USE IN SPECIFIC POPULATIONS In one study of 46 subjects who received CARDIOLITE® administration, the radioactivity in both children and adolescents exhibited blood PK profiles similar to those previously reported in adults. Lactation: Interruption of breastfeeding after exposure to Technetium Tc99m Sestamibi is not necessary, however, a lactating woman should be advised to consider restricting close contact with her breast fed infant to a maximum of 5 hours in the 24 hour period after Technetium Tc99m Sestamibi administration in order to minimize radiation exposure.
( 8.2 )
8.1Pregnancy 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.
If considering Technetium Tc99m Sestamibi administration to a pregnant woman, inform the patient about the potential for adverse pregnancy outcomes based on the radiation dose from Technetium Tc99m Sestamibi and the gestational timing of exposure. All pregnancies have a background risk of birth defects, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively.
8.2Lactation Risk Summary Limited data in the scientific literature on the presence of Technetium Tc99m Sestamibi in human milk, demonstrate that between 0.01% and 0.03% of maternal injected activity of technetium Tc99m Sestamibi was excreted in human milk. Technetium Tc99m Sestamibi accumulates in the lactating breast [see Clinical Considerations ] . There are limited data in the scientific literature on effects of Technetium Tc99m Sestamibi on the breastfed infant or on milk production The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for Technetium Tc99m Sestamibi and any potential adverse effects on the breastfed infant from Technetium Tc99m Sestamibi or from the underlying maternal condition.
Clinical Considerations Interruption of breastfeeding after exposure to Technetium Tc99m Sestamibi is not necessary because Technetium Tc99m Sestamibi excretion in breast milk is low. However, a lactating woman may restrict close contact with her breast fed infant to a maximum of 5 hours in the 24 hour period after Technetium Tc99m Sestamibi administration in order to minimize radiation exposure.
8.4Pediatric Use Safety and effectiveness in the pediatric population have not been established. No evidence of diagnostic efficacy or clinical utility of CARDIOLITE® scan was found in clinical studies of children and adolescents with Kawasaki disease. A prospective study of 445 pediatric patients with Kawasaki disease was designed to determine the predictive value of CARDIOLITE® rest and stress myocardial perfusion imaging to define a pediatric population with Kawasaki disease that was at risk of developing cardiac events.
Cardiac events were defined as cardiac death, MI, hospitalization due to cardiac etiology, heart failure, CABG or coronary angioplasty. The standard of truth was defined as cardiac events occurring 6 months following the administration of CARDIOLITE®. Only three cardiac events were observed at six months in this study.
In all three cases, the scan was negative. No clinically meaningful measurements of sensitivity, specificity or other diagnostic performance parameters could be demonstrated in this study. A ten year retrospective case history study of pediatric Kawasaki disease patients who completed CARDIOLITE® myocardial perfusion imaging and who had coronary angiography within three months of the CARDIOLITE…
🤰 Pregnancy ▾
8.1Pregnancy 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.
If considering Technetium Tc99m Sestamibi administration to a pregnant woman, inform the patient about the potential for adverse pregnancy outcomes based on the radiation dose from Technetium Tc99m Sestamibi and the gestational timing of exposure. All pregnancies have a background risk of birth defects, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively.
🧒 Pediatric Use ▾
8.4Pediatric Use Safety and effectiveness in the pediatric population have not been established. No evidence of diagnostic efficacy or clinical utility of CARDIOLITE® scan was found in clinical studies of children and adolescents with Kawasaki disease. A prospective study of 445 pediatric patients with Kawasaki disease was designed to determine the predictive value of CARDIOLITE® rest and stress myocardial perfusion imaging to define a pediatric population with Kawasaki disease that was at risk of developing cardiac events.
Cardiac events were defined as cardiac death, MI, hospitalization due to cardiac etiology, heart failure, CABG or coronary angioplasty. The standard of truth was defined as cardiac events occurring 6 months following the administration of CARDIOLITE®. Only three cardiac events were observed at six months in this study.
In all three cases, the scan was negative. No clinically meaningful measurements of sensitivity, specificity or other diagnostic performance parameters could be demonstrated in this study. A ten year retrospective case history study of pediatric Kawasaki disease patients who completed CARDIOLITE® myocardial perfusion imaging and who had coronary angiography within three months of the CARDIOLITE® scan was designed to measure sensitivity and specificity of CARDIOLITE® scan.
Out of 72 patients who had both evaluable CARDIOLITE® scans and evaluable angiographic images, only one patient had both an abnormal angiogram and an abnormal CARDIOLITE® scan. No clinically meaningful measurements of sensitivity, specificity or other diagnostic performance parameters could be demonstrated in this study. In a clinical pharmacology study, 46 pediatric patients with Kawasaki disease received CARDIOLITE® administration at the following doses: 0.1 - 0.2 mCi/kg for rest, 0.3 mCi/kg for stress in one day studies; 0.2 mCi/kg for rest and 0.2 mCi/kg for stress in two day studies.
The radioactivity both in younger children and in adolescents exhibited PK profiles similar to those previously reported in adults (See Section 12 ). The radiation absorbed doses in adolescents, both at rest and stress, were similar to those observed in adults (see Section 2 ). When comparing weight-adjusted radioactivity (up to 0.3 mCi/kg) doses administered to adolescents and younger children to the recommended dose administered to adults (up to 30 mCi), the radiation absorbed doses in both adolescents and younger children were similar to those in adults.
Adverse events were evaluated in 609 pediatric patients from the three clinical studies described above. The frequency and the type of the adverse events were similar to the ones observed in the studies of CARDIOLITE® in adults. Two of the 609 had a serious adverse event: one patient received a CARDIOLITE® overdose but remained asymptomatic, and one patient had an asthma exacerbation following administration.
🧓 Geriatric Use ▾
8.5Geriatric Use Of 3068 patients in clinical studies of CARDIOLITE®, Kit for the Preparation of Technetium Tc99m Sestamibi for Injection, 693 patients were 65 or older and 121 were 75 or older. Of 673 patients in clinical studies of MIRALUMA®, Kit for the Preparation of Technetium Tc99m Sestamibi for Injection, 138 patients were 65 or older and 30 were 75 or older. Based on the evaluation of the frequency of adverse events and review of vital signs data, no overall differences in safety were observed between these subjects and younger subjects.
Although reported clinical experience has not identified differences in response between elderly and younger patients, greater sensitivity of some older individuals cannot be ruled out.
🆘 Overdosage ▾
10. OVERDOSAGE The clinical consequences of overdosing with CARDIOLITE® are not known.
🧬 Clinical Pharmacology ▾
12. CLINICAL PHARMACOLOGY
12.1Mechanism 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.
12.3Pharmacokinetics Pulmonary activity is negligible even immediately after injection. Blood clearance studies indicate that the fast clearing component clears with a t 1/2 of 4.3 minutes at rest, and clears with a t 1/2 of 1.6 minutes under exercise conditions . At five minutes post injection about 8% of the injected dose remains in circulation.
There is less than 1% protein binding of Technetium Tc99m Sestamibi in plasma. The myocardial biological half-life is approximately six hours after a rest or exercise injection . The biological half-life for the liver is approximately 30 minutes after a rest or exercise injection.
The effective half-life of clearance (which includes both the biological half-life and radionuclide decay) for the heart is approximately 3 hours, and for the liver is approximately 30 minutes, after a rest or exercise injection. The ideal imaging time reflects the best compromise between heart count rate and surrounding organ uptake. Myocardial uptake which is coronary flow dependent is 1.2% of the injected dose at rest and 1.5% of the injected dose at exercise.
Table 6.0 illustrates the biological clearance as well as effective clearance (which includes biological clearance and radionuclide decay) of Tc99m Sestamibi from the heart and liver. [Organ concentrations expressed as percentage of injected dose; data based on an average of 5 subjects at rest and 5 subjects during exercise]. Table
6.0Biological and Effective Clearance REST STRESS Heart Liver Heart Liver Time Biological Effective Biological Effective Biological Effective Biological Effective 5 min. 1.2 1.2 19.6 19.4 1.5 1.5 5.9 5.8 30 min. 1.1 1.0 12.2 11.5 1.4 1.3 4.5 4.2 1 hour 1.0 0.9 5.6 5.0 1.4 1.2 2.4 2.1 2 hours 1.0 0.8 2.2 1.7 1.2 1.0 0.9 0.7 4 hours 0.8 0.5 0.7 0.4 1.0 0.6 0.3
0.2A study in a dog myocardial ischemia model reported that Technetium Tc99m Sestamibi undergoes myocardial distribution (redistribution), although more slowly and less completely than thallous chloride Tl-201. A study in a dog myocardial infarction model reported that the drug showed no redistribution of any consequence. Definitive human studies to demonstrate possible redistribution have not been reported.
In patients with documented myocardial infarction, imaging revealed the infarct up to four hours post dose. 12.3.1 Metabolism The agent is excreted without any evidence of metabolism. 12.3.2 Elimination The major pathway for clearance of Tc99m Sestamibi is the hepatobiliary system.
Activity from the gall bladder appears in the intestines within one hour of injection. Twenty-seven percent of the injected dose is excreted in the urine, and approximately thirty-three percent of the injected dose is cleared through the feces in 48 hours.
🧬 Mechanism of Action ▾
12.1Mechanism 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.
📦 How Supplied / Storage and Handling ▾
16. HOW SUPPLIED/STORAGE AND HANDLING CARDIOLITE®, Kit for the Preparation of Technetium Tc99m Sestamibi for Injection is supplied as a 5 mL vial in kits of five (5) vials (NDC # 87333-001-55) and twenty (20) vials (NDC # 87333-001-20), 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. Technetium Tc99m Sestamibi contains no preservatives.
Included in each five (5) vial kit is one (1) package insert, six (6) vial shield labels and six (6) radiation warning labels. 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 pursuant to the Code of Massachusetts Regulations 105 CMR 120.500 for the uses listed in 105 CMR 120.547 or 120.552, or under equivalent regulations of the U.S.
Nuclear Regulatory Commission, Agreement States or Licensing States.
📋 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 Tc99m 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 Tc99m[MIBI] 6 + where MIBI is 2-methoxy isobutyl isonitrile.
11.1Physical Characteristics Technetium Tc99m decays by isomeric transition with a physical half-life of 6.02 hours 1 . Photons that are useful for detection and imaging studies are listed below in Table 3.0. Table 3.0. Principal Radiation Emission Data Radiation Mean %/Disintegration Mean Energy (KeV) Gamma -2 89.07 140.5 1 Kocher, David, C., Radioactive Decay Data Tables, DOE/TIC-11026, 108(1981).
11.2External Radiation The specific gamma ray constant for Tc99m 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 4.0.
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 the radiation emitted by a factor of 1,000. Table 4.0. Radiation Attenuation by Lead Shielding Shield Thickness (Pb) cm Coefficient of Attenuation 0.017 0.5 0.08 10 -1 0.16 10 -2 0.25 10 -3 0.33 10 -4 To correct for physical decay of this radionuclide, the fractions that remain at selected intervals after the time of calibration are shown in Table 5.0.
Table
5.0 Physical Decay Chart; Tc99m Half-Life
6.02Hours Hours Fraction Remaining Hours Fraction Remaining 0 Calibration Time 1.000 8 .398 1 .891 9 .355 2 .794 10 .316 3 .708 11 .282 4 .631 12 .251 5 .562 6 .501 7 .447
💬 Information for Patients ▾
17. PATIENT COUNSELING INFORMATION CARDIOLITE ® and MIRALUMA ® are different names for the same drug. Patients should be advised to inform their health care provider if they had an allergic reaction to either drug or if they had an imaging study with either drug.
Lactation: Interruption of breastfeeding after exposure to Technetium Tc99m Sestamibi is not necessary, however, a lactating woman should be advised to consider restricting close contact with her breast fed infant to a maximum of 5 hours in the 24 hour period after Technetium Tc99m Sestamibi administration in order to minimize radiation exposure [see Use in Specific Populations (8.2) ] .