Medication Guide App

Technetium Tc 99m Sestamibi (Systemic)


VA CLASSIFICATION
Primary: DX201

Commonly used brand name(s): Cardiolite.

Other commonly used names are technetium Tc 99m
methoxyisobutylisonitrile and technetium Tc 99m MIBI .
Note: For a listing of dosage forms and brand names by country availability, see Dosage Forms section(s).



Category:


Diagnostic aid, radioactive (cardiac disease)—

Indications

Note: Bracketed information in the Indications section refers to uses that are not included in U.S. product labeling.

Accepted

Cardiac imaging, radionuclide
Myocardial infarction (diagnosis) and
Myocardial perfusion imaging, radionuclide—Technetium Tc 99m sestamibi is indicated in myocardial perfusion imaging to assess the severity and localization of the myocardial infarction. It also helps to demonstrate whether thrombolytic therapy has improved perfusion. {01} {02} {03} {14} {15} {21} {42}

Ischemia, myocardial (diagnosis)1—Technetium Tc 99m sestamibi is indicated in patients with known or suspected coronary artery disease to aid in the diagnosis of myocardial ischemia, orient investigative procedures, and guide treatment. In patients with unstable angina, technetium Tc 99m sestamibi is injected at the time of spontaneous chest pain to confirm diagnosis. {02} {04} {08} {14} {20} {26} {39}

Cardiac ventricular function assessment1 and
[Cardiac wall-motion abnormalities assessment]1—Technetium Tc 99m sestamibi is indicated for use in the determination of right and/or left ventricular ejection fraction by first-pass radionuclide angiocardiography; it is also used to assess regional wall motion. {03} {07} {10} {11} {26} {39} {42} {48}

[Stress electrocardiography adjunct]1—Technetium Tc 99m sestamibi is used as an adjunct to stress electrocardiography in the diagnosis of coronary artery disease, allowing simultaneous evaluation of myocardial perfusion and ventricular function. {10} {11} {12} {14} {16}

[Parathyroid imaging, radionuclide]1—Technetium Tc 99m sestamibi is used for the detection and localization of enlarged parathyroid glands in patients with hyperparathyroidism. {25} {32} {33} {48}

[Thyroid imaging, radionuclide]1—Technetium Tc 99m sestamibi is used for the detection and localization of various thyroid carcinomas (e.g., medullary, lymphoma, Hurthle cell). {37} {38} {40} {48}

1 Not included in Canadian product labeling.



Physical Properties

Nuclear data {05} {09}:



Radionuclide
(half-life)
Decay
constant
Mode
of
decay
Principal
photon
emissions
(keV)
Mean
number of
emissions/
disintegration
(³0.01)
Tc 99m
(6.0 hr)
0.1151 h -1
Isomeric
transition to
Tc 99
Gamma (18)
0.062
Gamma (140.5)
0.891


Pharmacology/Pharmacokinetics

Mechanism of action/Effect:

Cardiac imaging—The myocardial uptake of technetium Tc 99m sestamibi appears to occur by a passive diffusion process. The rate of passive uptake is determined by the membrane permeability of the drug and the surface area of the vascular beds to which it is exposed; thus myocardial uptake is related to myocardial blood flow. While the mechanism of myocardial retention is not completely understood, its distribution in myocardium appears to be analogous to that of thallous chloride Tl 201. When injected at rest, technetium Tc 99m sestamibi appears to accumulate in viable myocardial tissue; infarcts are thus delineated as areas of lack of accumulation. When injected at stress (either exercise or pharmacologic vasodilation), technetium Tc 99m sestamibi accumulates in myocardial tissue in relation to myocardial blood flow; thus ischemic areas (e.g., those supplied by stenotic vessels) are detected as areas of less accumulation. {01} {02} {03} {04} {07} {12} {26} {29}

Parathyroid imaging and

Thyroid imaging—Although the precise mechanism of tumor localization is unclear, it has been suggested that technetium Tc 99m sestamibi passively crosses cell membranes and is concentrated primarily within cytoplasm and mitochondria. It has been proposed that malignant cells, because of their increased metabolic rate, maintain greater negative mitochondrial and transmembrane potentials, thus enhancing intracellular accumulation of technetium Tc 99m sestamibi. In thyroid glands with hyperthyroidism, blood flow and the number of mitochondria are increased, which may explain the uptake of technetium Tc 99m sestamibi in hyperthyroid glands. Localization of technetium Tc 99m sestamibi appears to be dependent on blood flow to the tissue, the concentration of technetium Tc 99m sestamibi presented to the tissue, and the size of the gland. {34} {35} {36} {40} {43} {44} {46} {47}

Distribution:

High volume of distribution, with minimal cardiac redistribution. Rapidly cleared from blood after intravenous administration, accumulating in normal myocardium in relation to blood flow. The fast clearing component clears from the blood with a half-life of 4.3 minutes (at rest). At 5 minutes after injection, about 8% of the administered activity remains in circulation. Lung uptake is generally low, but there is considerable hepatic uptake. Technetium Tc 99m sestamibi is cleared through the biliary system into the intestine. {01} {02} {04} {07} {08} {10} {12} {14} {17} {29} {48}

Protein binding:

Very low (<1%). {01}

Half-life:


Elimination {01}:


Biological—

Myocardium—6 hours (after rest injection).

Liver—30 minutes (after rest injection).



Effective (includes biological half-life and radionuclide decay after rest injection)—

Myocardium—3 hours.

Liver—28 minutes.



Radiation dosimetry:
{39}

Organ
At rest
Estimated absorbed radiation dose*
With 2-hour
void
With 4.8-hour
void
mGy/
MBq
rad/
mCi
mGy/
MBq
rad/
mCi
Large intestine
wall (upper)

0.049

0.18

0.049

0.18
Large intestine
wall (lower)

0.035

0.13

0.038

0.14
Small intestine
0.027
0.10
0.027
0.10
Gallbladder wall
0.018
0.067
0.018
0.067
Kidneys
0.018
0.067
0.018
0.067
Bladder wall
0.018
0.067
0.038
0.14
Ovaries
0.014
0.050
0.014
0.053
Bone surfaces
0.0063
0.023
0.0063
0.023
Thyroid
0.0063
0.023
0.0063
0.023
Liver
0.0054
0.02
0.0054
0.02
Stomach wall
0.0054
0.02
0.0054
0.02
Red marrow
0.0046
0.017
0.0046
0.017
Heart wall
0.0046
0.017
0.0046
0.017
Testes
0.0027
0.010
0.0035
0.013
Breast
0.0018
0.0067
0.0018
0.0067
Total body
0.0045
0.017
0.0045
0.017


Radionuclide
Effective dose
With 2-hour
void
With 4.8-hour
void
mSv/
MBq
rem/
mCi
mSv/
MBq
rem/
mCi
Tc 99m
0.014
0.052
0.015
0.057


Organ
At stress
Estimated absorbed radiation dose*
With 2-hour
void
With 4.8-hour
void
mGy/
MBq
rad/
mCi
mGy/
MBq
rad/
mCi
Large intestine
wall (upper)

0.041

0.15

0.041

0.15
Large intestine
wall (lower)

0.030

0.11

0.030

0.11
Gallbladder wall
0.025
0.093
0.025
0.093
Small intestine
0.022
0.08
0.022
0.08
Kidneys
0.015
0.057
0.015
0.057
Bladder wall
0.014
0.050
0.027
0.10
Ovaries
0.011
0.040
0.012
0.043
Bone surfaces
0.0054
0.02
0.0054
0.02
Stomach wall
0.0045
0.017
0.0045
0.017
Heart wall
0.0045
0.017
0.0045
0.017
Red marrow
0.0045
0.017
0.0045
0.017
Liver
0.0036
0.013
0.0036
0.013
Lungs
0.0027
0.010
0.0018
0.0067
Thyroid
0.0027
0.010
0.0018
0.0067
Testes
0.0027
0.010
0.0027
0.010
Breast
0.0018
0.0067
0.0018
0.0067
Total body
0.0036
0.013
0.0036
0.013


Radionuclide
Effective dose
With 2-hour
void
With 4.8-hour
void
mSv/
MBq
rem/
mCi
mSv/
MBq
rem/
mCi
Tc 99m
0.013
0.045
0.013
0.048
* For adults; intravenous injection. Data based on the Radiopharmaceutical Internal Dose Information Center, July 1990. Oak Ridge Associated Universities. {39}

Elimination:


Within 48 hours—
        Renal, 27% of the administered activity.
        Fecal, 33% of the administered activity. {01}



Precautions to Consider

Pregnancy/Reproduction

Pregnancy—
Tc 99m (as free pertechnetate) crosses the placenta. Studies have not been done in humans.

The possibility of pregnancy should be assessed in women of child-bearing potential. Clinical situations exist in which the benefit to the patient and fetus, based on information derived from radiopharmaceutical use, outweighs the risks from radiation exposure to the fetus. In this situation, the physician should use discretion and reduce the administered activity of the radiopharmaceutical to the lowest possible amount. {05} {23} {29} {50}

Studies have not been done in animals.

FDA Pregnancy Category C. {01}

Breast-feeding

The percentage of the injected dose of technetium Tc 99m sestamibi distributed into milk has been found to be very low (0.0084% during the first 24 hours), and should not necessitate interruption of breast-feeding. However, since Tc 99m as free pertechnetate is distributed into breast milk, discontinuation of nursing for a period of 24 hours is generally recommended after administration of technetium Tc 99m–labeled radiopharmaceuticals. {01} {29} {30} {48}

Pediatrics

Although used in children, there have been no specific studies evaluating safety and efficacy. When used in children the diagnostic benefit should be judged to outweigh the potential risk of radiation. {29}


Geriatrics


Appropriate studies on the relationship of age to the effects of technetium Tc 99m sestamibi have not been performed in the geriatric population. However, clinical trials and studies including older patients were conducted and geriatrics-specific problems that would limit the usefulness of this agent in the elderly are not expected. {12} {15} {16}

Diagnostic interference
The following have been selected on the basis of their potential clinical significance (possible effect in parentheses where appropriate)—not necessarily inclusive (» = major clinical significance):

With results of this test
Radiotherapy    (radiation may affect binding of technetium Tc 99m sestamibi to intracellular proteins, thus decreasing its uptake in myocardial cells {27})


Medical considerations/Contraindications
The medical considerations/contraindications included have been selected on the basis of their potential clinical significance (reasons given in parentheses where appropriate)— not necessarily inclusive (» = major clinical significance).


Risk-benefit should be considered when the following medical problem exists
Sensitivity to the radiopharmaceutical preparation


Side/Adverse Effects

Note: One case has been reported of severe hypersensitivity, which was characterized by dyspnea, hypotension, bradycardia, asthenia, and vomiting within 2 hours after a second injection of technetium Tc 99m sestamibi. {39}

The following side/adverse effects have been selected on the basis of their potential clinical significance (possible signs and symptoms in parentheses where appropriate)—not necessarily inclusive:

Those indicating need for medical attention only if they continue or are bothersome
Incidence more frequent
    
Metallic or bitter taste{01}{31}{39}

Incidence less frequent or rare
    
Flushing of skin
    
headache
    
skin rash{39}





Patient Consultation
As an aid to patient consultation, refer to Advice for the Patient, Radiopharmaceuticals (Diagnostic).

In providing consultation, consider emphasizing the following selected information (» = major clinical significance):

Description of use
Action in the body: Accumulation of radioactivity in myocardial cells as a function of relative blood flow

Differences in uptake of radioactivity can be visualized

Small amounts of radioactivity used in diagnosis; radiation received is low and considered safe

Before having this test
»   Conditions affecting use, especially:
Sensitivity to the radiopharmaceutical preparation

Pregnancy—Technetium Tc 99m (as free pertechnetate) crosses placenta; risk to fetus from radiation exposure as opposed to benefit derived from study should be considered





Breast-feeding—Very small amount distributed into breast milk; temporary discontinuation of nursing may be recommended to avoid any unnecessary absorbed radiation dose to the infant





Use in children—Risk from radiation exposure as opposed to benefit derived from use should be considered


Preparation for this test
Special preparatory instructions may be given; patient should inquire in advance


General Dosing Information
Radiopharmaceuticals are to be administered only by or under the supervision of physicians who have had extensive training in the safe use and handling of radioactive materials and who are authorized by the Nuclear Regulatory Commission (NRC) or the appropriate Agreement State agency, if required, or, outside the U.S., the appropriate authority. {41}

Imaging with technetium Tc 99m sestamibi to assess the distribution of myocardial perfusion at the time of the infarct in patients who have received the agent prior to, or at the initiation of, thrombolytic therapy (< 4 hours), is possible up to 6 hours after the intravenous injection of this agent, due to the absence of significant redistribution in the myocardium. Thus, the assessment of the amount of hypoperfused myocardium (e.g., the area at risk) is possible without having to delay the administration of thrombolytic therapy. {07} {21} {48}

In conjunction with exercise or pharmacologic stress testing, technetium Tc 99m sestamibi should be administered at the inception of a period of maximum stress that lasts for approximately 1 to 3 minutes after injection. {20} {26} {48}

After intravenous injection, redistribution of technetium Tc 99m sestamibi in the myocardium is minimal or non-existent. For this reason, separate stress and rest injections are required to distinguish reversible stress-induced ischemia from irreversible perfusion defects. {17} {20}

Technical factors such as tomographic reconstruction artifacts, patient movement, diaphragmatic attenuation, and breast attenuation in female patients may cause false-positive results (false perfusion defects). {08}

High liver extraction of technetium Tc 99m sestamibi may interfere with visualization of the inferior wall of the heart. Delaying imaging for at least 1 hour should facilitate tracer clearance from the liver. {06} {08} {10} {26} {29}

When used to examine myocardial perfusion, the optimal time interval for imaging is approximately 1 to 4 hours after administration of technetium Tc 99m sestamibi. {01} {20} {26} {48}

Safety considerations for handling this radiopharmaceutical
Improper handling of this radiopharmaceutical may cause radioactive contamination. Guidelines for handling radioactive material have been prepared by scientific, professional, state, federal, and international bodies and are available to the specially qualified and authorized users who have access to radiopharmaceuticals. {49}


Parenteral Dosage Forms

Note: Bracketed uses in the Dosage Forms section refer to categories of use and/or indications that are not included in U.S. product labeling.

TECHNETIUM Tc 99m SESTAMIBI INJECTION{51} USP

Usual adult and adolescent administered activity
Cardiac imaging
Intravenous, 370 to 1110 megabecquerels (10 to 30 millicuries). {01} {39}

Note: For same-day rest-stress studies, to differentiate ischemia from scar, administration of a low dose (7 millicuries) at rest followed 2 hours later by a higher dose (25 millicuries) at stress has been found to be useful and to give results similar to the 2-day protocol. {20} {26}


[Parathyroid imaging]1
Intravenous, 370 to 740 megabecquerels (10 to 20 millicuries). {33} {48}

[Thyroid imaging]1
Intravenous, 370 to 740 megabecquerels (10 to 20 millicuries). {37} {38} {40} {45}


Usual pediatric administered activity
Minimum dosage has not been established. {29}

Usual geriatric administered activity
See Usual adult and adolescent administered activity .

Strength(s) usually available
U.S.—


1.0 mg of tetrakis (2-methoxy isobutyl isonitrile) Copper (I) tetrafluoroborate, 2.6 mg sodium citrate dihydrate, 1.0 mg L-cysteine hydrochloride monohydrate, 20 mg mannitol, 0.025 mg dihydrate stannous chloride (minimum), 0.075 mg dihydrate stannous chloride, 0.086 mg dihydrate tin chloride (stannous and stannic, maximum), per 5-mL reaction vial (Rx) [Cardiolite]

Canada—


1.0 mg of tetrakis (2-methoxy isobutyl isonitrile) Copper (I) tetrafluoroborate, 2.6 mg sodium citrate dihydrate, 1.0 mg L-cysteine hydrochloride monohydrate, 20 mg mannitol, 0.025 mg dihydrate stannous chloride (minimum), 0.075 mg dihydrate stannous chloride, 0.086 mg dihydrate tin chloride (stannous and stannic, maximum), per 5-mL reaction vial (Rx) [Cardiolite]

Packaging and storage:
Store between 15 and 25 °C (59 and 77 °F), unless otherwise specified by manufacturer. Protect from freezing. {01} {39} {51}

Preparation of dosage form:
To prepare technetium Tc 99m sestamibi injection, an oxidant-free sodium pertechnetate Tc 99m solution is used. See manufacturer's package insert for instructions. {04}

Stability:
Product is stable; package insert states that injection must be used within 6 hours after preparation. {01} {29}

Incompatibilities:
If oxidants such as peroxides and hypochlorites are present in the sodium pertechnetate Tc 99m used for labeling, the final preparation may be adversely affected and should be discarded.

Note: Caution—Radioactive material.




Revised: 04/25/1995



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