THALLOUS CHLORIDE Tl 201

THALLOUS CHLORIDE TL 201- thallous chloride tl-201 injection, solution
Curium US LLC

1 INDICATIONS AND USAGE

Thallous Chloride Tl 201 Injection is a diagnostic radiopharmaceutical indicated for

  • Myocardial perfusion imaging with planar scintigraphy or single-photon emission computed tomography (SPECT) for the diagnosis of coronary artery disease by localization of:
    • Non-reversible defects (myocardial infarction) which may have prognostic value regarding survival.
    • Reversible defects (myocardial ischemia) when used in conjunction with exercise or pharmacologic stress.
  • Localization of sites of parathyroid hyperactivity pre- and post-operatively in patients with elevated serum calcium and parathyroid hormone levels.

2 DOSAGE AND ADMINISTRATION

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% 201 Tl, 0.3% 200 Tl, 1.2% 202 Tl, and 0.2% 203 Pb. 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

Effective Dose

5.77E-02

0.145mSv/MBq

2.14E-01

0.535rem/mCi

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