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Thallous Tl (Thallous Chloride, TL-201) - Warnings and Precautions

 
 



WARNINGS AND PRECAUTIONS

Anaphylactoid Reactions

Anaphylactoid reactions (hypotension, pruritus, flushing, and diffuse rash) have been reported.

Risks Associated with Stress Testing

Perform stress testing only under the supervision of a qualified physician and in a laboratory equipped with appropriate resuscitation and support equipment. Patients suspected or known to have myocardial infarction or ischemia, require continuous clinical monitoring and treatment in accordance with safe, accepted procedures.

Induction of cardiovascular stress might be associated with serious adverse events such as myocardial infarction, arrhythmia, hypotension or hypertension, ECG abnormalities, chest pain,  bronchoconstriction, and cerebrovascular events. Perform pharmacologic stress when indicated and in accordance with the pharmacologic stress agent’s prescribing information.

Radiation Risks

Thallous Chloride Tl 201 contributes to the cumulative radiation exposure. When considering administration of Thallous Chloride injection to women of child-bearing potential, consider the radiation risks for a fetus [see Use in Specific Populations ].

Use the lowest dose necessary for imaging and ensure safe handling to protect the patient and health care worker [see Dosage and Administration (2.1)(2.5)].

Risk of Extravasation

Inject Thallous Chloride Tl 201 strictly intravenously to avoid local tissue accumulation and irradiation.

USE IN SPECIFIC POPULATIONS

Pregnancy Category C

There are no adequate or well-controlled studies of Thallous Chloride Tl 201 Injection use in pregnant women. Studies using human placentas demonstrate that Thallous Chloride Tl 201 crosses the placenta. Animal reproductive studies have not been conducted. Administer Thallous Chloride Tl 201 Injection to a pregnant woman only if clearly needed.

Nursing Mothers

Thallous Chloride Tl 201 is excreted in human milk. Advise patients who continue to breastfeed to express and discard milk for a minimum of 2 weeks after administration of Thallous Chloride Tl 201. Minimize close contact with infants if the administered dose would result in an effective dose greater than 1 mSv (0.1 rem) to the infant.

Pediatric Use

Safety and effectiveness of Thallous Chloride Tl 201 Injection in pediatric patients have not been established.

Females of Reproductive Potential

Assess the pregnancy status of women of childbearing potential prior to performing imaging procedures with Thallous Chloride Tl 201 Injection [see Warnings and Precautions].

Page last updated: 2013-08-31

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