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warnings and cautions
5 WARNINGS AND PRECAUTIONS Anaphylactoid reactions (hypotension, pruritus, flushing, and diffuse rash) have been reported. ( 5.1 ) Induction of cardiovascular stress may be associated with myocardial infarction, arrhythmia, hypotension, bronchoconstriction, cerebrovascular events and other serious adverse events. ( 5.2 ) 5.1 Anaphylactoid Reactions Anaphylactoid reactions (hypotension, pruritus, flushing, and diffuse rash) have been reported. 5.2 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. 5.3 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 ( 8.1 )] . 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 )]. 5.4 Risk of Extravasation Inject Thallous Chloride Tl 201 strictly intravenously to avoid local tissue accumulation and irradiation.
6 ADVERSE REACTIONS Serious adverse reactions associated with myocardial perfusion testing including myocardial infarction, arrhythmia, hypotension, bronchoconstriction, and cerebrovascular events have been reported in patients who have undergone stress testing. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Mallinckrodt Inc. at 1-800-778-7898 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Serious Reactions Anaphylactoid Reactions Following the administration of Thallous Chloride Tl 201 Injection, anaphylactoid reactions have been reported (characterized by cardiovascular, respiratory and cutaneous symptoms), some considered serious and severe enough to require treatment. Hypotension, pruritus, flushing, and diffuse rash which responds to antihistamines have been reported. Stress Testing Serious reactions reported in patients who have undergone stress testing include myocardial infarction, arrhythmia, hypotension, bronchoconstriction, and cerebrovascular events [see Warnings ( 5 )] . 6.2 Common Reactions The most frequently reported reactions were itching, nausea, vomiting, mild diarrhea, tremor, shortness of breath, chills, fever, conjunctivitis, sweating, and blurred vision.