Thallous Chloride Tl 201 Injection

Warnings and Precautions

• Hypersensitivity reactions (anaphylaxis, hypotension, shortness of breath, pruritus, flushing, and diffuse rash) have been reported. Have resuscitation equipment and trained staff readily available.
• Risk associated with Stress Testing: Induction of cardiovascular stress may be associated with myocardial infarction, arrhythmia, hypotension or hypertension, ECG abnormalities, chest pain, bronchoconstriction, and cerebrovascular events. Perform stress testing in the setting where cardiac resuscitation equipment and trained staff are readily available.  Perform pharmacologic stress in accordance with the pharmacologic stress agent’s prescribing information.
• Radiation Risk: Thallous Chloride Tl 201 contributes to the overall long-term cumulative radiation exposure which is associated with an increased risk of cancer. Ensure safe handling to minimize radiation exposure to patients and health care providers. Advise patients to hydrate before and after administration and to void frequently after administration.
• Injection site reactions and Tissue Damage: Injection site reactions and extravasation have been reported after administration of Thallous Chloride Tl 201 Injection. Inject Thallous Chloride Tl 201 strictly into the vein to avoid local tissue accumulation and irradiation. Confirm intravenous patency before injection.

Adverse Reactions

• Other adverse reactions include nausea, vomiting, diarrhea, injection site reactions, chills, fever, and sweating

Use in Specific Populations

• Pregnancy: Assess the pregnancy status of women of childbearing potential prior to performing imaging procedures with Thallous Chloride Tl 201 Injection. 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.
• Lactation: Thallous Chloride Tl 201 is excreted in human milk. Discontinue nursing or express and discard milk for a minimum of 96 hours after administration of Thallous Chloride Tl 201.
• Pediatric Use: Safety and effectiveness have not been established in pediatric patients.
• Geriatric Use: This drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function.