Kit For The Preparation Of Technetium Tc99m Sestamibi
Kit For The Preparation Of Technetium Tc99m Sestamibi Prescribing Information
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.
• 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 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).• 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).
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 AcquisitionBreast 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 DosimetryThe 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 DoseREST
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.
2.3 Instructions for PreparationPreparation of the Technetium Tc 99m Sestamibi from the Kit for Preparation of Technetium Tc 99m Sestamibi Injection is done by the following aseptic procedure:
Boiling Water Bath Procedure:a. Prior to adding the Sodium Pertechnetate Tc 99m 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.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 Tc 99m Injection [925-5550 MBq, (25–150 mCi)] in approximately 1 to 3 mL.e. Aseptically add the Sodium Pertechnetate Tc 99m 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.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 Tc 99m 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 Tc 99m Sestamibi at 15° to 25°C until use; at such time the product should be aseptically withdrawn. Technetium Tc 99m Sestamibi should be used within six hours of preparation. The vial contains no preservative.
Note:Adherence to the above product reconstitution instructions is recommended.Cardinal Health 414, LLC's Kit for the Preparation of Technetium Tc 99m Sestamibi Injection is not to be used with the Recon-o-Stat™ thermal cycler due to the smaller vial size requirements of this heating device.
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 Tc 99m Sestamibi1.000000000000000e+00 Obtain a Baker-Flex Aluminum Oxide coated, plastic TLC plate, #1 B-F, pre-cut to 2.5 cm x 7.5 cm.2.000000000000000e+00 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.3.000000000000000e+00 Apply 1 drop of ethanol1using 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.4.000000000000000e+00 Add 2 drops of Technetium Tc 99m Sestamibi solution, side by side on top of the ethanol1spot. Return the plate to a desiccator and allow the sample spot to dry (typically 15 minutes).5.000000000000000e+00 The TLC tank is prepared by pouring ethanol1to a depth of 3-4 mm. Cover the tank and let it equilibrate for ~10 minutes.6.000000000000000e+00 Develop the plate in the covered TLC tank in ethanol1for a distance of 5 cm from the point of application.7.000000000000000e+00 Cut the TLC plate 4 cm from the bottom and measure the Tc 99m activity in each piece by appropriate radiation detector.8.000000000000000e+00 Calculate the % Tc 99m Sestamibi as:
Figure 1 TLC Plate Diagram
1The 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.
% Tc99m Calculation Formula TLC Plate Diagram • 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 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).• 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).
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 AcquisitionBreast 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 DosimetryThe 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 DoseREST
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.
2.3 Instructions for PreparationPreparation of the Technetium Tc 99m Sestamibi from the Kit for Preparation of Technetium Tc 99m Sestamibi Injection is done by the following aseptic procedure:
Boiling Water Bath Procedure:a. Prior to adding the Sodium Pertechnetate Tc 99m 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.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 Tc 99m Injection [925-5550 MBq, (25–150 mCi)] in approximately 1 to 3 mL.e. Aseptically add the Sodium Pertechnetate Tc 99m 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.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 Tc 99m 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 Tc 99m Sestamibi at 15° to 25°C until use; at such time the product should be aseptically withdrawn. Technetium Tc 99m Sestamibi should be used within six hours of preparation. The vial contains no preservative.
Note:Adherence to the above product reconstitution instructions is recommended.Cardinal Health 414, LLC's Kit for the Preparation of Technetium Tc 99m Sestamibi Injection is not to be used with the Recon-o-Stat™ thermal cycler due to the smaller vial size requirements of this heating device.
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 Tc 99m Sestamibi1.000000000000000e+00 Obtain a Baker-Flex Aluminum Oxide coated, plastic TLC plate, #1 B-F, pre-cut to 2.5 cm x 7.5 cm.2.000000000000000e+00 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.3.000000000000000e+00 Apply 1 drop of ethanol1using 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.4.000000000000000e+00 Add 2 drops of Technetium Tc 99m Sestamibi solution, side by side on top of the ethanol1spot. Return the plate to a desiccator and allow the sample spot to dry (typically 15 minutes).5.000000000000000e+00 The TLC tank is prepared by pouring ethanol1to a depth of 3-4 mm. Cover the tank and let it equilibrate for ~10 minutes.6.000000000000000e+00 Develop the plate in the covered TLC tank in ethanol1for a distance of 5 cm from the point of application.7.000000000000000e+00 Cut the TLC plate 4 cm from the bottom and measure the Tc 99m activity in each piece by appropriate radiation detector.8.000000000000000e+00 Calculate the % Tc 99m Sestamibi as:
Figure 1 TLC Plate Diagram1The 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.
% Tc99m Calculation Formula TLC Plate Diagram
Kit for Preparation of Technetium Tc 99m Sestamibi Injection is supplied as a lyophilized mixture in a 5 mL vial.
• In one study of 46 subjects who received Technetium Tc 99m Sestamibi administration, the radioactivity in both children and adolescents exhibited blood PK profiles similar to those previously reported in adults ().8.4 Pediatric UseSafety and effectiveness in the pediatric population have not been established.
No evidence of diagnostic efficacy or clinical utility of Technetium Tc 99m Sestamibi 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 Technetium Tc 99m Sestamibi 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 Technetium Tc 99m Sestamibi. 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 Technetium Tc 99m Sestamibi myocardial perfusion imaging and who had coronary angiography within three months of the Technetium Tc 99m Sestamibi scan was designed to measure sensitivity and specificity of Technetium Tc 99m Sestamibi scan. Out of 72 patients who had both evaluable Technetium Tc 99m Sestamibi scans and evaluable angiographic images, only one patient had both an abnormal angiogram and an abnormal Technetium Tc 99m Sestamibi 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 Technetium Tc 99m Sestamibi 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 Clinical Pharmacology].The radiation absorbed doses in adolescents, both at rest and stress, were similar to those observed in adults [
see Dosage and Administration]. 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 Technetium Tc 99m Sestamibi in adults. Two of the 609 had a serious adverse event: one patient received a Technetium Tc 99m Sestamibi overdose but remained asymptomatic, and one patient had an asthma exacerbation following administration.
None known.
• Pharmacologic induction of cardiovascular stress may be associated with serious adverse events such as myocardial infarction, arrhythmia, hypotension, bronchoconstriction and cerebrovascular events ().5.1 WarningsIn 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].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.
• 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 Technetium Tc 99m Sestamibi imaging ().5.1 WarningsIn 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].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.
• Caution should be exercised and emergency equipment should be available when administering Technetium Tc 99m Sestamibi ().5.1 WarningsIn 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].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.
• Before administering Technetium Tc 99m Sestamibi Injection, patients should be asked about the possibility of allergic reactions to either drug ().5.1 WarningsIn 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].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.
• The contents of the vial are intended only for use in the preparation of Technetium Tc 99m Sestamibi and are not to be administered directly to the patient without first undergoing the preparative procedure ().5.2 General PrecautionsThe contents of the vial are intended only for use in the preparation of Technetium Tc 99m 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 Tc 99m 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 Tc 99m labeling reactions depend on maintaining the stannous ion in the reduced state. Hence, Sodium Pertechnetate Tc 99m Injection containing oxidants should not be used.
Technetium Tc 99m 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%
Arrhythmia
1%