Thallous chloride tl-201

FDA label, Curium US LLC, intravenous, effective 2025-12-22. Full label on DailyMed

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Quoted from the FDA label. Product labels differ by manufacturer and change over time; confirm against the label for the product you are using.

Dosing in kidney impairment

Table 1. Estimated Absorbed Radiation Dose per Injected Activity in Organs and Tissues of Adults from Intravenous Administration of Thallous Chloride Tl 201 Injection 1
Organ/ Tissue Absorbed Dose per Unit Activity Administered (mGy/MBq)
Adrenals0.063
Brain0.057
Breasts0.034
GB Wall0.083
GI Tract
LLI Wall0.300
Small Intestine0.379
Stomach0.171
ULI Wall0.297
Heart Wall0.247
Kidneys0.410
Liver0.094
Lungs0.047
Muscle0.046
Ovaries0.102
Pancreas0.075
Red Marrow0.044
Bone Surfaces0.094
Skin0.032
Spleen0.166
Testes0.209
Thymus0.046
Thyroid0.542
Urinary Bladder Wall0.063
Uterus0.086
Total Body0.058
Effective Dose (mSv/MBq)0.145
Table 1. Estimated Absorbed Radiation Dose per Injected Activity in Organs and Tissues of Adults from Intravenous Administration of Thallous Chloride Tl 201 Injection 1
Organ/ Tissue Absorbed Dose per Unit Activity Administered (mGy/MBq)
Adrenals0.063
Brain0.057
Breasts0.034
GB Wall0.083
GI Tract
LLI Wall0.300
Small Intestine0.379
Stomach0.171
ULI Wall0.297
Heart Wall0.247
Kidneys0.410
Liver0.094
Lungs0.047
Muscle0.046
Ovaries0.102
Pancreas0.075
Red Marrow0.044
Bone Surfaces0.094
Skin0.032
Spleen0.166
Testes0.209
Thymus0.046
Thyroid0.542
Urinary Bladder Wall0.063
Uterus0.086
Total Body0.058
Effective Dose (mSv/MBq)0.145

Preparation and administration

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Basis

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Administration and Imaging Instructions Patient Preparation Instruct patients to hydrate before and after Thallous Chloride Tl 201 Injection administration and to void before imaging and frequently thereafter following Thallous Chloride Tl 201 Injection administration [see Warnings and Precautions] . Administration Use aseptic technique and radiation shielding when withdrawing and administering Thallous Chloride Tl 201 Injection.

Visually inspect the drug for particulate matter and discoloration prior to administration, whenever the solution and container permit. Do not use if contents are turbid or discolored. Measure the patient dose with a dose calibrator immediately prior to administration. Use within 6 days from the manufacturer’s calibration date or 9 days from the date of manufacture, whichever comes first.

Dispose of unused products in a safe manner in compliance with applicable regulations. Myocardial Perfusion Imaging For resting myocardial studies, begin imaging 10 minutes to 20 minutes after administration of Thallous Chloride Tl 201 Injection. Target-to-background ratios are improved when patients are injected upright and in the fasting state; the upright position reduces the hepatic and gastric thallium-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 10 minutes after administration to obtain maximum target-to-background ratios. Within 2 hours after the completion of the stress testing, the target-to-background ratios may decrease in lesions that are attributable to transient ischemia.

Parathyroid Hyperactivity Localization 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 injection or sodium iodide I 123 capsules to enable thyroid subtraction imaging.

Administration and Imaging Instructions Patient Preparation Instruct patients to hydrate before and after Thallous Chloride Tl 201 Injection administration and to void before imaging and frequently thereafter following Thallous Chloride Tl 201 Injection administration [see Warnings and Precautions] . Administration Use aseptic technique and radiation shielding when withdrawing and administering Thallous Chloride Tl 201 Injection.

Visually inspect the drug for particulate matter and discoloration prior to administration, whenever the solution and container permit. Do not use if contents are turbid or discolored. Measure the patient dose with a dose calibrator immediately prior to administration. Use within 6 days from the manufacturer’s calibration date or 9 days from the date of manufacture, whichever comes first.

Dispose of unused products in a safe manner in compliance with applicable regulations. Myocardial Perfusion Imaging For resting myocardial studies, begin imaging 10 minutes to 20 minutes after administration of Thallous Chloride Tl 201 Injection. Target-to-background ratios are improved when patients are injected upright and in the fasting state; the upright position reduces the hepatic and gastric thallium-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 10 minutes after administration to obtain maximum target-to-background ratios. Within 2 hours after the completion of the stress testing, the target-to-background ratios may decrease in lesions that are attributable to transient ischemia.

Parathyroid Hyperactivity Localization 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 injection or sodium iodide I 123 capsules to enable thyroid subtraction imaging.

Contraindications

None. None

Pregnancy and lactation

Pregnancy

8.1 Pregnancy Risk Summary There are no data on Thallous Chloride Tl 201 Injection use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. Studies using human placentas demonstrate that thallous chloride Tl 201 crosses the placenta. No animal reproductive studies have been conducted. All radiopharmaceuticals, including Thallous Chloride Tl 201 Injection have the potential to cause fetal harm depending on the fetal stage of development and the magnitude of the radiation dose.

If considering administration of Thallous Chloride Tl 201 Injection to a pregnant woman, inform the patient about the potential for adverse pregnancy outcomes based on the radiation dose from Thallous Chloride Tl 201 Injection and gestational timing of exposure. The background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defects, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 3% and 10% to 20%, respectively.

For breastfeeding, also see LactMed (National Library of Medicine), which summarizes milk levels and infant effects.

Supply and cost

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Therapeutic equivalence (Orange Book)

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