Brand Name
Tl 201
View Brand InformationFDA approval date: November 04, 2015
Classification: Radioactive Diagnostic Agent
Form: Injection
What is Tl 201?
Thallous Chloride Tl 201 Injection is a diagnostic radiopharmaceutical indicated for Myocardial perfusion imaging with planar scintigraphy or single-photon emission computed tomography for the diagnosis of coronary artery disease by localization of: Non-reversible defects which may have prognostic value regarding survival. Reversible defects 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. Thallous Chloride Tl 201 Injection is a diagnostic radiopharmaceutical indicated for Myocardial perfusion imaging with planar scintigraphy or single-photon emission computed tomography for the diagnosis of coronary artery disease by localization of: Non-reversible defects Reversible defects 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.
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Brand Information
THALLOUS CHLORIDE Tl 201 (thallous chloride, Tl 201)
1INDICATIONS AND USAGE
Thallous Chloride Tl 201 Injection is indicated for use with planar scintigraphy or single-photon emission computed tomography (SPECT) for the following applications:
- Myocardial perfusion imaging in adults for the diagnosis of coronary artery disease by localization of:
- Localization of sites of parathyroid hyperactivity pre- and post-operatively in adults with elevated serum calcium and parathyroid hormone levels
2DOSAGE FORMS AND STRENGTHS
Injection: a clear, colorless solution available in the following strength at calibration time:
- 207.2 MBq (5.6 mCi) per 5.6 mL (37 MBq (1 mCi) per mL) in a multiple-dose vial
3CONTRAINDICATIONS
None.
4ADVERSE REACTIONS
The following clinically significant adverse reactions are described elsewhere in the labeling:
- Hypersensitivity Reactions
- Risk Associated with Stress Testing
- Injection Site Reactions and Tissue Damage
The following adverse reactions associated with the use of Thallous Chloride Tl 201 Injection were identified in clinical studies or postmarketing reports. Because some of these reactions were reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure:
Cardiovascular, respiratory, and cerebrovascular disorders:myocardial infarction, arrhythmia, hypotension, bronchoconstriction, and cerebrovascular events in patients who have undergone stress testing
Gastrointestinal disorders:nausea, vomiting, and diarrhea
General disorders and administration site conditions:injection site reactions (burning, pain, redness, swelling, warmth, and tissue damage with chronic ulcer formation), chills, fever, and sweating
Immune system disorders:hypersensitivity (anaphylaxis, hypotension, shortness of breath, pruritus, flushing, and diffuse rash)
5OVERDOSAGE
In the event of the administration of an overdose of Thallous Chloride Tl 201 Injection, the absorbed dose to the patient should be reduced where possible by increasing the excretion of the radionuclide by forced diuresis with frequent voiding and stimulation of peristalsis.
6HOW SUPPLIED/STORAGE AND HANDLING
How Supplied
Thallous Chloride Tl 201 Injection is supplied as a clear, colorless solution in the following strength at calibration time:
Thallous Chloride Tl 201 Injection is supplied as a clear, colorless solution in the following strength at calibration time:
207.2 MBq (5.6 mCi) per 5.6 mL (37 MBq (1 mCi) per mL) in a multiple-dose vial (NDC 69945-120-56)
Storage and Handling
Store Thallous Chloride Tl 201 Injection in the original container with radiation shielding at 20°C to 25°C (68°F to 77°F) [see USP Controlled Room Temperature].
Dispose of any unused product in accordance with all federal, state, and local laws and institutional requirements.
This preparation is for use by persons under license by the Nuclear Regulatory Commission or the relevant regulatory authority of an Agreement State.
7PATIENT COUNSELING INFORMATION
Radiation Risk
Advise patients of the radiation risk of Thallous Chloride Tl 201 Injection. Instruct patients to drink water to ensure adequate hydration prior to administration of Thallous Chloride Tl 201 Injection and to continue drinking and voiding frequently following administration to reduce radiation exposure [see Warnings and Precautions ( .
Advise patients of the radiation risk of Thallous Chloride Tl 201 Injection. Instruct patients to drink water to ensure adequate hydration prior to administration of Thallous Chloride Tl 201 Injection and to continue drinking and voiding frequently following administration to reduce radiation exposure [see Warnings and Precautions ( .
Pregnancy
Inform pregnant women of the risk of fetal exposure to radiation dose if they undergo an imaging procedure with Thallous Chloride Tl 201 Injection [see Use in Specific Populations ( .
Lactation
Advise a lactating woman to temporarily discontinue breastfeeding and to pump and discard breastmilk for at least 96 hours after administration of Thallous Chloride Tl 201 Injection to minimize radiation exposure to a breastfed infant [see Use in Specific Populations ( .
Manufactured by:
Curium US LLC
Made in USA
©2025 Curium US LLC. Curium
A120I0
CURIUM™
8PRINCIPAL DISPLAY PANEL
Thallous Chlloride TI 201 Injection For Intravenous Administration
Multiple-dose vial
Store at Controlled Room Temperature 20 ºto 25ºC (68 ºto 77ºF) [see USP].
Rx only
CAUTION RADIOACTIVE MATERIAL
CAUTION RADIOACTIVE MATERIAL
Manufactured by:
Made in USA
A120V0 R11/2025
