Cardiolite

Cardiolite is an FDA-registered drug product whose active ingredient is TETRAKIS(2-METHOXYISOBUTYLISOCYANIDE)COPPER(I) TETRAFLUOROBORATE. It is labelled by SHINE SPECT USA, LLC taken by intravenous and marketed as a human prescription drug product. Identifiers on file: NDC 87333-001, application NDA019785, label effective 20260910. It is one of 3 FDA drug label records sharing the active ingredient TETRAKIS(2-METHOXYISOBUTYLISOCYANIDE)COPPER(I) TETRAFLUOROBORATE. This page reproduces the FDA-approved label text so you can check what a product is, who makes it and how it is supplied before discussing it with a pharmacist or prescriber.

Across FDA labelling, products containing TETRAKIS(2-METHOXYISOBUTYLISOCYANIDE)COPPER(I) TETRAFLUOROBORATE are most often described in connection with: myocardial ischemia, perfusion agent, detecting coronary, artery disease, reversible defects, infarction non-reversible, developing information, patient management. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

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.

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). 2.1 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 Tc99m Sestamibi: ten-minute lateral image of breast with abnormality ten-minute lateral image of contralateral breast ten-minute anterior image of both breasts 2.2 Radiation 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 1.9 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 7.0 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 Kidneys 1.7 16.7 1.7 16.7 Liver 0.4 4.2 0.4 4.1 Lungs 0.3 2.6 0.2 2.4 Bone Surfaces 0.6 6.2 0.6 6.0 Thyroid 0.3 2.7 0.2 2.4 Ovaries 1.2 12.2 1.3 13.3 Testes 0.3 3.1 0.3 3.4 Red Marrow 0.5 4.6 0.5 4.4 Urinary Bladder Wall 1.5 15.5 3.0 30.0 Total Body 0.4 4.2 0.4 4.2 2.3 Instructions 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 the surface. Boiling Water Bath Procedure: c.Place the vial in a suitable radiation shield with a fitted radiation cap. d.With a sterile shielded syringe, aseptically obtain additive-free, sterile, non-pyrogenic Sodium Pertechnetate Tc99m Injection [925 - 5550 MBq, (25 - 150 mCi)] in approximately 1 to 3 mL. e.Aseptically add the Sodium Pertechnetate Tc99m Injection to the vial in the lead shield. Without withdrawing the needle, remove an equal volume of headspace to maintain atmospheric pressure within the vial. f.Shake vigorously, about 5 to 10 quick upward-downward motions. g.Remove the vial from the lead shield and place upright in an appropriately shielded and contained boiling water bath, such that the vial is suspended above the bottom of the bath, and boil for 10 minutes. Timing for 10 minutes is begun as soon as the water begins to boil again. Do not allow the boiling water to come in contact with the aluminum crimp. h.Remove the vial from the water bath, place in the lead shield and allow to cool for fifteen minutes. Recon-o-Stat (thermal cycler) Procedure: c.Place the vial in the thermal cycler radiation shield. d.With a sterile shielded syringe, aseptically obtain additive-free, sterile, non-pyrogenic Sodium Pertechnetate Tc99m Injection [925 - 5550 MBq, (25 - 150 mCi)] in approximately 1 to 3 mL. e.Aseptically add the Sodium Pertechnetate Tc99m Injection to the vial in the lead shield. Without withdrawing the needle, remove an equal volume of headspace to maintain atmospheric pressure within the vial . f.Shake vigorously, about 5 to 10 quick upward-downward motions. g.Place shield on sample block. While slightly pressing downward, give the shield a quarter turn to make certain there is a firm fit between the shield and the sample block. h.Press the proceed button to initiate the program (the thermal cycler automatically heats & cools the vial and contents). Please see the Recon-o-Stat Instruction Manual for further details. General Procedure (cont.): i.Using proper shielding, the vial contents should be visually inspected. Use only if the solution is clear and free of particulate matter and discoloration. j.Assay the reaction vial using a suitable radioactivity calibration system. Record the Technetium Tc99m concentration, total volume, assay time and date, expiration time and lot number on the vial shield label and affix the label to the shield. k.Store the reaction vial containing the Technetium Tc99m Sestamibi at 15° to 25°C (59-77°F) until use; at such time the product should be aseptically withdrawn. Technetium Tc99m Sestamibi should be used within six hours of preparation. The vial contains no preservative. Note: Adherence to the above product reconstitution instructions is recommended. The potential for cracking and significant contamination exists whenever vials containing radioactive material are heated. Product should be used within 6 hours after preparation. Final product with radiochemical purity of at least 90% was used in the clinical trials that established safety and effectiveness. The radiochemical purity was determined by the following method. 2.4 Determination of Radiochemical Purity in Technetium Tc99m Sestamibi Obtain a Baker-Flex Aluminum Oxide coated, plastic TLC plate, #1 B-F, pre-cut to 2.5 cm × 7.5 cm. Dry the plate or plates at 100°C for 1 hour and store in a desiccator. Remove pre-dried plate from the desiccator just prior to use. Apply 1 drop of ethanol The ethanol used in this procedure should be 95% or greater. Absolute ethanol (99%) should remain at ≥ 95% ethanol content for one week after opening if stored tightly capped, in a cool dry place. using a 1 mL syringe with a 22-26 gauge needle, 1.5 cm from the bottom of the plate. THE SPOT SHOULD NOT BE ALLOWED TO DRY. Add 2 drops of Technetium Tc99m Sestamibi solution, side by side on top of the ethanol spot. Return the plate to a desiccator and allow the sample spot to dry (typically 15 minutes). The TLC tank is prepared by pouring ethanol to a depth of 3-4 mm. Cover the tank and let it equilibrate for ~10 minutes. Develop the plate in the covered TLC tank in ethanol for a distance of 5 cm from the point of application. Cut the TLC plate 4 cm from the bottom and measure the Tc99m activity in each piece by appropriate radiation detector. Calculate the % Tc99m Sestamibi as: % Tc99m Sestamibi = µCi Top Piece × 100 µCi Both Pieces Figure 1.0 TLC Plate Diagram Figure 1.0

4. CONTRAINDICATIONS None known. None known.

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 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.

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 2.0 Selected 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 .

FDA lists 3 drug label records with TETRAKIS(2-METHOXYISOBUTYLISOCYANIDE)COPPER(I) TETRAFLUOROBORATE as the active ingredient. The most common dosage forms and the manufacturers with the most records are summarised below; strengths, pack sizes and inactive ingredients can still differ between apparently similar products.

What is Cardiolite used for?
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 …

Who makes Cardiolite?
SHINE SPECT USA, LLC is the labeler of record for Cardiolite. 3 FDA label records share the active ingredient TETRAKIS(2-METHOXYISOBUTYLISOCYANIDE)COPPER(I) TETRAFLUOROBORATE, so generic and branded versions may come from different companies; the manufacturer named on your pack is the one that matters for any enquiry.

What form does Cardiolite come in?
administered by intravenous. Strengths and pack sizes vary by label, so compare the NDC on your pack with the identifier listed on this page.

Is Cardiolite prescription or over-the-counter?
The FDA label for this product is recorded as human prescription drug. Marketing status can differ between strengths and countries, so check the dispensing rules where you live.

Are there other products containing TETRAKIS(2-METHOXYISOBUTYLISOCYANIDE)COPPER(I) TETRAFLUOROBORATE?
Yes. 3 FDA drug label records list TETRAKIS(2-METHOXYISOBUTYLISOCYANIDE)COPPER(I) TETRAFLUOROBORATE as the active ingredient. Products with the same active ingredient can usually be substituted only when a prescriber or pharmacist confirms it is appropriate.

Has Cardiolite been recalled?
No FDA recall record in our database matches this product name or manufacturer. Recall data is updated periodically, so a very recent notice may not appear here yet.

Where does this information come from?
All content is reproduced from FDA Structured Product Labelling data via openFDA. It is provided for identification and reference only and is not medical advice.