Thallous Chloride Tl 201 label

Thallous Chloride Tl 201

Thallous Chloride Tl 201 Recall

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Side Effects & Adverse Reactions

When studying patients suspected or known to have myocardial infarction or ischemia, care should be taken to assure continuous clinical monitoring and treatment in accordance with safe, accepted procedure. Exercise 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 contents of this vial are radioactive. Adequate shielding of the preparation must be maintained at all times.

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Uses

Thallous Chloride Tl 201 may be useful in myocardial perfusion imaging for the diagnosis and localization of myocardial infarction. It may also have prognostic value regarding survival, when used in the clinically stable patient following the onset of symptoms of an acute myocardial infarction, to assess the site and size of the perfusion defect.

Thallous Chloride Tl 201 may also be useful in conjunction with exercise stress testing as an adjunct in the diagnosis of ischemic heart disease (atherosclerotic coronary artery disease) .

It is usually not possible to differentiate recent from old myocardial infarction, or to differentiate exactly between recent myocardial infarction and ischemia.

Thallous Chloride Tl 201 is indicated also for the localization of sites of parathyroid hyperactivity in patients with elevated serum calcium and parathyroid hormone levels. It may also be useful in pre-operative screening to localize extrathyroidal and mediastinal sites of parathyroid hyperactivity and for post-surgical reexamination. Thallous Chloride Tl 201 has not been adequately demonstrated to be effective for the localization of normal parathyroid glands.

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Other Information

Thallous Chloride Tl 201 Injection is supplied in isotonic solution as a sterile, nonpyrogenic, diagnostic radiopharmaceutical for intravenous administration. Each unit dose contains 1 mL and each milliliter contains 37 MBq (1 mCi) of Thallous Chloride Tl 201 Injection at calibration time. The pH is adjusted to 4.5-7.5 with hydrochloric acid or sodium hydroxide. It is made isotonic with 9 mg sodium chloride/mL and is preserved with 0.009 mL benzyl alcohol/mL.

Thallium Tl 201 is cyclotron produced with no carrier added. The radionuclidic composition at calibration time, expressed as percent of total activity, is not less than 98 percent Thallium Tl 201 with not more than 0.3 percent Thallium Tl 200 , not more than 1.2 percent Thallium Tl 202, not more than 0.2 percent Lead Pb 203, and not more than 0.3 percent all others.

The concentration of each radionuclidic contaminant changes with time. Therefore, it is recommended that Thallous Chloride Tl 201 Injection be administered close to calibration time to minimize the effect of higher levels of radionuclidic contaminants pre and post calibration. Graph 1 shows maximum allowable concentration of each radionuclidic contaminant as a function of time.

Graph 1. Radionuclidic Contaminants
Image from Drug Label Content

PHYSICAL CHARACTERISTICS

Thallium Tl 201 decays by electron capture to Mercury Hg 201 with a physical half-life of 73.1 hours. Photons that are useful for detection and imaging are listed in Table 1. The lower energy x-rays obtained from the Mercury Hg 201 daughter of Tl 201 are recommended for myocardial imaging because the mean %/disintegration at 68.9-80.3 keV is much greater than the combination of gamma-4 and gamma-6 mean %/disintegration.

Table 1. Principal Radiation Emission Data*
Radiation Mean
%/Disintegration		 Mean
Energy (keV)
*
Kocher David C, “Radionuclidic Decay Data Tables.” DOE/TIC-11026, 182 (1981)
Gamma-4   2.7 135.3
Gamma-6 10.0 167.4
Mercury x-rays 94.4 68.9-80.3

EXTERNAL RADIATION

The specific gamma ray constant for Thallium Tl 201 is 3.21 microcoulombs/hr-kg-MBq (0.46 R/hr-mCi) at 1 cm. The first half-value layer is 0.023 cm of lead. A range of values for the relative attenuation of the radiation emitted by this radionuclide that results from the interposition of various thicknesses of lead (Pb) is shown in Table 2. For example, the use of 0.31 cm of lead will decrease the external radiation exposure by a factor of about 1,000.

Table 2. Radiation Attenuation by Lead Shielding*
cm of Lead (Pb) Coefficient of Attenuation
*
Method of calculation: Data dated 1984 supplied by Oak Ridge Associated Universities. Radiopharmaceutical Internal Dose Information Center.
0.023 0.5
0.081 10-1
0.19   10-2
0.31   10-3
0.44   10-4

To correct for physical decay of this radionuclide, the fractions that remain at selected intervals and after calibration are shown in Table 3.

Table 3. Thallium Tl 201 Decay Chart: Half-life 73.1 Hours
Hours Fraction
Remaining		 Hours Fraction
Remaining		 Hours Fraction
Remaining
*
Calibration time
   0* 1.00 42 0.67 84 0.45
  6 0.94 48 0.63 90 0.43
12 0.89 54 0.60 96 0.40
18 0.84 60 0.57 108 0.36
24 0.80 66 0.53 120 0.32
30 0.75 72 0.51
36 0.71 78 0.48

At two and four days post calibration, Thallium Tl 201 concentrations amount only to about 63% and 40%, respectively, of their initial value. This condition would require use of proportionately larger volume doses.

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Thallous Chloride Tl 201 Manufacturers

  • Ge Healthcare, Medi-physics, Inc.
    Thallous Chloride Tl 201 | Ge Healthcare, Medi-physics, Inc.
    No Recall

    Thallous Chloride Tl 201 | Ge Healthcare, Medi-physics, Inc.

    Thallous Chloride Tl 201 | Ge Healthcare, Medi-physics, Inc.

    The recommended adult (70 kg) dose of Thallous Chloride Tl 201 Injection is 37-74 MBq (1-2 mCi). Thallous Chloride Tl 201 Injection is intended for intravenous administration only.

    Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

    The patient dose should be measured by a suitable radioactivity calibration system immediately prior to administration.

    Aseptic procedures should be employed in the withdrawal of the dose for patient administration.

    For resting thallium studies, imaging should begin 10-20 minutes after injection. Myocardial-to-background ratios are improved when patients are injected upright and in the fasting state; the upright position reduces the hepatic and gastric Thallium Tl 201 concentration.

    When utilized in conjunction with exercise stress testing, Thallous Chloride Tl 201 Injection should be administered at the inception of a period of maximum stress which is sustained for approximately 30 seconds after injection. Imaging should begin within 10 minutes after administration to obtain maximum target-to-background ratios. Several investigators have reported that within two hours after the completion of stress testing the target-to-background ratios may decrease significantly in lesions that are attributable to transient ischemia.

    For the localization of parathyroid hyperactivity, Thallous Chloride Tl 201 may be administered before, with or after a minimal dose of a thyroid imaging agent such as sodium pertechnetate Tc99m or sodium iodide I 123 to enable thyroid subtraction imaging.

    RADIATION DOSIMETRY

    The estimated absorbed doses at calibration time to an average patient (70 kg) from an intravenous injection of a maximum dose of 74 MBq, 2 mCi of Thallous Chloride Tl 201 Injection are shown in Table 4.

    Table 4. Radiation Dose Estimates of Thallous Chloride Tl 201 Injection: Absorbed Dose/74 MBq, 2 mCi Thallium Tl 201 Administered* Tissue mGy/74 MBq Rads/2 mCi * Values listed include an average maximum correction of 8% to the radiation doses from Thallous Chloride Tl 201 Injection due to the radiocontaminants Thallium Tl 200 and Thallium Tl 202 at calibration time. Heart Wall 10.0 1.0   Liver 12.0 1.2   Kidneys 24.0 2.4   Testes 11.0 1.1   Ovaries   9.6 0.96 Thyroid   9.6 0.96 Gastrointestinal Tract:   Stomach Wall   8.2 0.82   Small Intestine   7.8 0.78   Upper Large Intestine Wall   5.2 0.52   Lower Large Intestine Wall   4.4 0.44 Total Body   4.4 0.44
  • Lantheus Medical Imaging, Inc.
    Thallous Chloride Tl 201 | Lantheus Medical Imaging, Inc.
    No Recall

    Thallous Chloride Tl 201 | Lantheus Medical Imaging, Inc.

    Thallous Chloride Tl 201 | Lantheus Medical Imaging, Inc.

    DOSAGE AND ADMINISTRATION: The recommended adult dose of intravenous Thallous Chloride Tl 201 Injection for planar myocardial imaging is 37 to 74 MBq (1-2 mCi). The recommended intravenous doses for SPECT myocardial imaging are 74 to 111 MBq (2-3 mCi). The efficacy of a 1.0 mCi dose SPECT imaging has not been well established.

    Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

    The patient dose should be measured by a suitable radioactivity calibration system immediately prior to administration.

    For patients undergoing resting thallium studies, imaging is optimally begun within 10-20 minutes after injection. Several investigators have reported improved myocardial-to-background ratios when patients are injected in the fasting state, in an upright posture, or after briefly ambulating. The upright position reduces the hepatic and gastric Thallium TI 201 concentration.

    Best results with thallium imaging performed in conjunction with exercise stress testing appear to be obtained if the thallium is administered when the patient reaches maximum stress and when the stress is continued for 30 seconds to one minute after injection. Imaging should begin within ten minutes post-injection since target-to-background ratio is optimum by that time. Several investigators have reported significant decreases in the target-to-background ratios of lesions attributable to transient ischemia by two hours after the completion of stress Imaging.

    For the localization of parathyroid hyperactivity, Thallous Chloride Tl 201 Injection may be administered before, with or after a minimal dose of a thyroid imaging agent such as sodium pertechnetate Tc99m or sodium iodide I 123 to enable thyroid subtraction imaging.

    RADIATION DOSIMETRY Table 4 Radiation Dose Estimates for Thallous Chloride Tl 201 Injection (plus contaminants) Estimate Radiation Dose Organ MGy/MBq Rad/mCi Adrenals .065 0.24 Brain .061 0.22 Breasts .036 0.13 GB Wall .084 0.31 LLI Wall .34 1.3 Small Intestine .45 1.7 Stomach .19 0.69 ULI .33 1.2 Heart Wall .28 1.0 Kidneys .46 1.7 Liver .099 0.37 Lungs .048 0.18 Muscle .047 0.17 Ovaries .10 0.38 Pancreas .075 0.28 Marrow .056 0.21 Bone Surfaces .089 0.33 Skin .034 0.13 Spleen .18 0.66 Testes .83 3.1 Thymus .047 0.17 Thyroid .62 2.3 Urinary Bladder wall .053 0.20 Uterus .086 0.32 Effective Dose Equiv. .36 mSv/MBq 1.3 rem/mCi

    Based on data gathered in humans by Krahwinkel et al. (J Nucl Med 29(9):1582-1586, 1988) and data gathered in humans by Gupta et al. (Int J Nucl Med & Biol 8:211-213, 1981).

    Bladder voiding interval 4.8hr. Contaminants assumed: TI-200 (0.3%), TI-202 (0.84%), Pb-203 (0.2%). Includes dose from TI-201 Auger electrons. Estimate calculated using phantom of Cristy & Eckerman (Report ORNL/TM-8381/V1 & V7). Radiation Internal Dose Information Center.

  • Mallinckrodt Inc.
    Thallous Chloride Tl 201 | Mallinckrodt Inc.
    No Recall

    Thallous Chloride Tl 201 | Mallinckrodt Inc.

    Thallous Chloride Tl 201 | Mallinckrodt Inc.
    2.1 Radiation Safety

    Thallous Chloride Tl 201 Injection emits radiation and must be handled with appropriate safety measures and in accordance with the “as low as reasonably achievable” (ALARA) principle of radioactivity dosing.

    Use the lowest dose of Thallous Chloride Tl 201 Injection necessary to obtain the intended diagnostic image. Individualize the dose and consider factors such as body size, and the equipment and technique to be employed. 

    2.2 Recommended Dose

    Myocardial perfusion

    Planar scintigraphy: 37 to 74 MBq (1 to 2 mCi) administered intravenously SPECT: 74 to 111 MBq (2 to 3 mCi) administered intravenously

    Parathyroid hyperactivity localization

    Planar or SPECT: 75 to 130 MBq (2 to 3.5 mCi) administered intravenously

    2.3 Drug Administration and Imaging

    For resting myocardial studies, begin imaging 10 to 20 minutes after injection of Thallous Chloride Tl 201. Myocardial-to-background ratios are improved when patients are injected upright and in the fasting state; the upright position reduces the hepatic and gastric Thallium Tl 201 concentration.

    For exercise stress testing administer Thallous Chloride Tl 201 Injection at the start of a period of maximum stress which is sustained for approximately
    30 seconds after injection. Begin imaging within ten minutes after administration to obtain maximum target-to-background ratios. Within two hours after the completion of the stress testing the target-to-background ratios may decrease in lesions that are attributable to transient ischemia.

    For localization of parathyroid hyperactivity, administer Thallous Chloride
    Tl 201 Injection before, with or after a minimal dose of a thyroid imaging agent such as sodium pertechnetate Tc 99m or sodium iodide I 123 to enable thyroid subtraction imaging. 

    2.4 Radiation Dosimetry

    The estimated absorbed radiation doses at calibration time to a 70 kg patient from an intravenous injection of Thallous Chloride Tl 201 are shown in Table 1. The estimates were calculated based on human data from Krahwinkel et al.1 and Thomas et al.2 Assumed percentages of 98.3% 201Tl, 0.3% 200Tl, 1.2% 202Tl, and 0.2% 203Pb. The effective dose was calculated using ICRP 103 tissue weighting factors and assumptions on the biodistribution data based on data from Krahwinkel et al. and Thomas et al.

    Table 1. Radiation Dose Estimates for Thallous Chloride Tl 201  (includes contaminants)

    Organ

    Estimated Radiation Dose

    mGy/MBq

    rad/mCi

    Adrenals

    6.33E-02

    2.34E-01

    Brain

    5.68E-02

    2.10E-01

    Breasts

    3.39E-02

    1.25E-01

    GB Wall  

    8.31E-02

    3.07E-01

    LLI Wall

    2.96E-01

    1.09E+00

    Small Intestine

    3.79E-01

    1.40E+00

    Stomach

    1.71E-01

    6.34E-01

    ULI Wall

    2.97E-01

    1.10E+00

    Heart Wall

    2.47E-01

    9.14E-01

    Kidneys

    4.10E-01

    1.52E+00

    Liver

    9.39E-02

    3.47E-01

    Lungs

    4.73E-02

    1.75E-01

    Muscle

    4.59E-02

    1.70E-01

    Ovaries

    1.02E-01

    3.76E-01

    Pancreas

    7.52E-02

    2.78E-01

    Red Marrow

    4.44E-02

    1.64E-01

    Bone Surfaces

    9.37E-02

    3.47E-01

    Skin

    3.16E-02

    1.17E-01

    Spleen

    1.66E-01

    6.14E-01

    Testes 

    2.09E-01

    7.73E-01

    Thymus

    4.60E-02

    1.70E-01

    Thyroid

    5.42E-01

    2.00E+00

    Urinary Bladder Wall   

    6.25E-02

    2.31E-01

    Uterus

    8.63E-02

    3.19E-01

    Total Body

    5.77E-02

    2.14E-01

    Effective Dose

    0.145mSv/MBq

    0.535rem/mCi

    1 Krahwinkel W, Herzog H, Feinendegen LE. Pharmacokinetics of
    thallium-201 in normal individuals after routine myocardial scintigraphy.
    J Nucl Med, 1988; 29, 1582–1586. 2 Thomas SR, Stabin MG, Castronovo FP. Radiation-absorbed dose from
    201Tl-thallous chloride . J Nucl Med, 2005; 46(3), 502-508. 2.5 Drug Handling Do not use this drug after six (6) days from the calibration date, or nine (9) days from date of manufacture, whichever comes first. Limit the use of this drug, to physicians who are qualified by training and experience in the safe use and handling of radionuclides. Wear waterproof gloves during the handling procedures. Aseptically withdraw the material for use with a shielded sterile syringe. Measure the patient dose with a suitable radioactivity calibration system immediately prior to administration. Visually inspect the drug for particulate matter and discoloration prior to administration, whenever solution and container permit.  Do not use if contents are turbid. Minimize radiation exposure to the patient and insure minimum radiation exposure to occupational workers.
      2.1 Radiation Safety

    Thallous Chloride Tl 201 Injection emits radiation and must be handled with appropriate safety measures and in accordance with the “as low as reasonably achievable” (ALARA) principle of radioactivity dosing.

    Use the lowest dose of Thallous Chloride Tl 201 Injection necessary to obtain the intended diagnostic image. Individualize the dose and consider factors such as body size, and the equipment and technique to be employed. 

    2.2 Recommended Dose

    Myocardial perfusion

    Planar scintigraphy: 37 to 74 MBq (1 to 2 mCi) administered intravenously SPECT: 74 to 111 MBq (2 to 3 mCi) administered intravenously

    Parathyroid hyperactivity localization

    Planar or SPECT: 75 to 130 MBq (2 to 3.5 mCi) administered intravenously

    2.3 Drug Administration and Imaging

    For resting myocardial studies, begin imaging 10 to 20 minutes after injection of Thallous Chloride Tl 201. Myocardial-to-background ratios are improved when patients are injected upright and in the fasting state; the upright position reduces the hepatic and gastric Thallium Tl 201 concentration.

    For exercise stress testing administer Thallous Chloride Tl 201 Injection at the start of a period of maximum stress which is sustained for approximately
    30 seconds after injection. Begin imaging within ten minutes after administration to obtain maximum target-to-background ratios. Within two hours after the completion of the stress testing the target-to-background ratios may decrease in lesions that are attributable to transient ischemia.

    For localization of parathyroid hyperactivity, administer Thallous Chloride
    Tl 201 Injection before, with or after a minimal dose of a thyroid imaging agent such as sodium pertechnetate Tc 99m or sodium iodide I 123 to enable thyroid subtraction imaging. 

    2.4 Radiation Dosimetry

    The estimated absorbed radiation doses at calibration time to a 70 kg patient from an intravenous injection of Thallous Chloride Tl 201 are shown in Table 1. The estimates were calculated based on human data from Krahwinkel et al.1 and Thomas et al.2 Assumed percentages of 98.3% 201Tl, 0.3% 200Tl, 1.2% 202Tl, and 0.2% 203Pb. The effective dose was calculated using ICRP 103 tissue weighting factors and assumptions on the biodistribution data based on data from Krahwinkel et al. and Thomas et al.

    Table 1. Radiation Dose Estimates for Thallous Chloride Tl 201  (includes contaminants)

    Organ

    Estimated Radiation Dose

    mGy/MBq

    rad/mCi

    Adrenals

    6.33E-02

    2.34E-01

    Brain

    5.68E-02

    2.10E-01

    Breasts

    3.39E-02

    1.25E-01

    GB Wall  

    8.31E-02

    3.07E-01

    LLI Wall

    2.96E-01

    1.09E+00

    Small Intestine

    3.79E-01

    1.40E+00

    Stomach

    1.71E-01

    6.34E-01

    ULI Wall

    2.97E-01

    1.10E+00

    Heart Wall

    2.47E-01

    9.14E-01

    Kidneys

    4.10E-01

    1.52E+00

    Liver

    9.39E-02

    3.47E-01

    Lungs

    4.73E-02

    1.75E-01

    Muscle

    4.59E-02

    1.70E-01

    Ovaries

    1.02E-01

    3.76E-01

    Pancreas

    7.52E-02

    2.78E-01

    Red Marrow

    4.44E-02

    1.64E-01

    Bone Surfaces

    9.37E-02

    3.47E-01

    Skin

    3.16E-02

    1.17E-01

    Spleen

    1.66E-01

    6.14E-01

    Testes 

    2.09E-01

    7.73E-01

    Thymus

    4.60E-02

    1.70E-01

    Thyroid

    5.42E-01

    2.00E+00

    Urinary Bladder Wall   

    6.25E-02

    2.31E-01

    Uterus

    8.63E-02

    3.19E-01

    Total Body

    5.77E-02

    2.14E-01

    Effective Dose

    0.145mSv/MBq

    0.535rem/mCi

    1 Krahwinkel W, Herzog H, Feinendegen LE. Pharmacokinetics of
    thallium-201 in normal individuals after routine myocardial scintigraphy.
    J Nucl Med, 1988; 29, 1582–1586. 2 Thomas SR, Stabin MG, Castronovo FP. Radiation-absorbed dose from
    201Tl-thallous chloride . J Nucl Med, 2005; 46(3), 502-508. 2.5 Drug Handling Do not use this drug after six (6) days from the calibration date, or nine (9) days from date of manufacture, whichever comes first. Limit the use of this drug, to physicians who are qualified by training and experience in the safe use and handling of radionuclides. Wear waterproof gloves during the handling procedures. Aseptically withdraw the material for use with a shielded sterile syringe. Measure the patient dose with a suitable radioactivity calibration system immediately prior to administration. Visually inspect the drug for particulate matter and discoloration prior to administration, whenever solution and container permit.  Do not use if contents are turbid. Minimize radiation exposure to the patient and insure minimum radiation exposure to occupational workers.
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