vsample [0.01:600 X maximal human dose). Pregnancy Category C Animal reproduction and teratogenicity studies have not been conducted with Technetium Tc99m Sestamibi. It is also not known whether Technetium Tc99m 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 Tc99m Sestamibi should be given to a pregnant woman only if clearly needed. Nursing Mothers Technetium Tc99m Pertechnetate is excreted in human milk during lactation. It is not known whether Technetium Tc99m Sestamibi is excreted in human milk. Therefore, formula feedings should be substituted for breast feedings. Pediatric Use Safety and effectiveness in the pediatric population have not been established. Geriatric 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. 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 Warnings and Precautions ). Adverse events reported at a rate of 0.5% or greater after receiving Technetium Tc99m Sestamibi administration are shown in the following table: Table 9 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 were 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. 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). 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 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 10. Table 10. Radiation Absorbed Doses from Tc99m 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 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 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, (865) 576-3448. DRUG HANDLING: 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. Store at 15-25 C before and after reconstitution. INSTRUCTIONS FOR PREPARATION OF TECHNETIUM Tc99m Sestamibi for Injection 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: 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. 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 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. 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 x 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* 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 X 100 µCi Both Pieces * 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. How is Cardiolite Supplied Cardiolite , Kit for the Preparation of Technetium Tc99m Sestamibi for Injection is supplied as a 5 mL vial in kits of two (2) (NDC # 11994-001-52), five (5) (NDC # 11994-011-55), and twenty (20) (NDC # 11994-001-20), sterile and non-pyrogenic. 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 before and after reconstitution. Technetium Tc99m Sestamibi contains no preservatives. Included in each two (2) vial kit is one (1) package insert, six (6) vial shield labels and six (6) radiation warning labels. 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 120.533 or under equivalent licenses of the U.S. Nuclear Regulatory Commission, Agreement States or Licensing States. Distributed by Bristol-Myers Squibb Medical Imaging 331 Treble Cove Road N. Billerica, Massachusetts 01862 USA For Ordering Tel: Toll Free 800-225-1572 All Other Business: 800-362-2668 (For Massachusetts and International, call 978-667-9531) Printed in the U.S.A. 513121-0503 May 2003 CARDIOITE tetrakis(1-isocyano-2-methoxy-2-methyl-propane)-copper(i) tetrafluoroborate injection, powder, lyophilized, for solution Product Information Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) 11994-001 Route of Administration INTRAVENOUS DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TETRAKIS(1-ISOCYANO-2-METHOXY-2-METHYL-PROPANE)-COPPER(I) TETRAFLUOROBORATE (TETRAKIS(1-ISOCYANO-2-METHOXY-2-METHYL-PROPANE)-COPPER(I) TETRAFLUOROBORATE) TETRAKIS(1-ISOCYANO-2-METHOXY-2-METHYL-PROPANE)-COPPER(I) TETRAFLUOROBORATE 1 mg Inactive Ingredients Ingredient Name Strength Sodium Citrate Dihydrate 2.6 mg in 1 Mannitol 20 mg in 1 Sodium Citrate Dihydrate 75 ug in 1 L-Cystiene Hydrochloride Monohydrate 1 mg in 1 Packaging # Item Code Package Description 1 NDC:11994-001-52 2 VIAL (2 VIAL) in 1 PACKAGE 1 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION (1 VIAL) in 1 VIAL 2 NDC:11994-001-55 5 VIAL (5 VIAL) in 1 PACKAGE 2 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION (1 VIAL) in 1 VIAL 3 NDC:11994-001-20 20 VIAL (20 VIAL) in 1 PACKAGE 3 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION (1 VIAL) in 1 VIAL Labeler - Bristol-Myers Squibb Medical Imaging Revised: 02/2006 Bristol-Myers Squibb Medical Imaging Next User Reviews Print this page Add to My Med List More about Cardiolite (sestamibi) Side Effects Dosage Information Support Group 0 Reviews Add your own review/rating Drug class: radiologic conjugating agents Consumer resources Cardiolite Professional resources Technetium TC 99M Sestamibi (FDA) Related treatment guides Diagnosis and Investigation]} FEATURED: CAR-T Cell Therapy Overview Mechanism of Action KTE-C19 Studies KTE-C19 Cancer Targets Adverse Events Manufacturing Drug Status Availability Unknown C Pregnancy Category Risk cannot be ruled out N/A CSA Schedule Not a controlled drug Drug Class Radiologic conjugating agents Related Drugs radiologic conjugating agents Zevalin , bicisate dihydrochloride , tetrofosmin , sestamibi , Neurolite , exametazime Diagnosis and Investigation glucagon , arginine , Lexiscan , mannitol , L-Arginine , GlucaGen , Tubersol , inulin , Metopirone , regadenoson , Aplisol , Gastrografin , tuberculin purified protein derivative , diatrizoate , Thyrogen , gadobutrol , methacholine , Lipiodol , tetrofosmin , Lipiodol Ultra-Fluide , Gadavist , sestamibi , exametazime , metyrapone , More... 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