Data from FDA - Curated by EPG Health - Last updated 01 June 2018

Indication(s)

INDICATIONS AND USAGE: Thallous Chloride TI 201 Injection may be useful in myocardial perfusion imaging using either planar or SPECT (Single Photon Computed Tomography) techniques for the diagnosis and localization of myocardial infarction. It may also have prognostic value regarding survival, when used in the clinically stable patient following the onset of symptoms of an acute myocardial infarction, to assess the site and size of the perfusion defect. Thallous Chloride TI 201 Injection may also be useful in conjunction with exercise stress testing as an adjunct in the diagnosis of ischemic heart disease (atherosclerotic coronary artery disease). It is usually not possible to differentiate recent from old myocardial infarction, or to differentiate between recent myocardial infarction and ischemia. Thallous Chloride TI 201 Injection is indicated also for the localization of sites of parathyroid hyperactivity in patients with elevated serum calcium and parathyroid hormone levels. It may also be useful in pre-operative screening to localize extrathyroidal and mediastinal sites of parathyroid hyperactivity and for postsurgical reexamination. Thallous Chloride Tl 201 Injection has not been adequately demonstrated to be effective for the localization of normal parathyroid glands.

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Advisory information

contraindications
CONTRAINDICATIONS: None known.
Special warnings and precautions
PRECAUTIONS: Data are not available concerning the effect of marked alterations in blood glucose, insulin, or pH (such as is found in diabetes mellitus) on the quality of Thallous Chloride TI 201 Injection scans. Attention is directed to the fact that thallium is a potassium analog, and since the transport of potassium is affected by these factors, the possibility exists that the thallium may likewise be affected. General Do not use after the expiration time and date (5 days maximum after calibration time) stated on the label. Do not use if contents are turbid. The patient dose should be measured by a suitable radioactivity calibration system immediately prior to administration. Thallous Chloride TI 201 Injection, as all radioactive materials, must be handled with care and used with appropriate safety measures to minimize external radiation exposure to clinical personnel. Care should also be taken to minimize radiation exposure to patients in a manner consistent with proper patient management. Radiopharmaceuticals should be used only by physicians who are qualified by training and experience in the safe use and handling of radionuclides. Carcinogenesis, Mutagenesis, Impairment of Fertility No long-term animal studies have been performed to evaluate carcinogenic potential, mutagenic potential, or whether Thallous Chloride Tl 201 Injection affects fertility in males or females. Ideally, examinations using radiopharmaceuticals, especially those elective in nature, of a woman of child-bearing capability should be performed during the first few (approximately 10) days following the onset of menses. Pregnancy Adequate reproductive studies have not been conducted in animals with Thallous Chloride Tl 201 Injection. It is also not known whether Thallous Chloride TI 201 Injection can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Thallous Chloride Tl 201 Injection should not be given to a pregnant woman except when benefits clearly outweigh the potential risks. Nursing Mothers It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, nursing should not be undertaken when a patient is administered radioactive material. Pediatric Use Safety and effectiveness in the pediatric population has not been established. Geriatric Use Clinical studies of Thallous Chloride TI 201 Injection did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.
Adverse reactions
ADVERSE REACTIONS: Following the administration of Thallous Chloride Tl 201 Injection, adverse anaphylactoid reactions have been reported (characterized by cardiovascular, respiratory, and cutaneous symptoms), some severe enough to require treatment. Hypotension, pruritus, flushing and diffuse rash which responds to antihistamines have been reported. Other reported events include itching, nausea/vomiting, mild diarrhea, tremor, shortness of breath, chills, fever, conjunctivitis, sweating and blurred vision.

Usage information

Dosing and administration
DOSAGE AND ADMINISTRATION: The recommended adult dose of intravenous Thallous Chloride Tl 201 Injection for planar myocardial imaging is 37 to 74 MBq (1-2 mCi). The recommended intravenous doses for SPECT myocardial imaging are 74 to 111 MBq (2-3 mCi). The efficacy of a 1.0 mCi dose SPECT imaging has not been well established. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. The patient dose should be measured by a suitable radioactivity calibration system immediately prior to administration. For patients undergoing resting thallium studies, imaging is optimally begun within 10-20 minutes after injection. Several investigators have reported improved myocardial-to-background ratios when patients are injected in the fasting state, in an upright posture, or after briefly ambulating. The upright position reduces the hepatic and gastric Thallium TI 201 concentration. Best results with thallium imaging performed in conjunction with exercise stress testing appear to be obtained if the thallium is administered when the patient reaches maximum stress and when the stress is continued for 30 seconds to one minute after injection. Imaging should begin within ten minutes post-injection since target-to-background ratio is optimum by that time. Several investigators have reported significant decreases in the target-to-background ratios of lesions attributable to transient ischemia by two hours after the completion of stress Imaging. For the localization of parathyroid hyperactivity, Thallous Chloride Tl 201 Injection may be administered before, with or after a minimal dose of a thyroid imaging agent such as sodium pertechnetate Tc99m or sodium iodide I 123 to enable thyroid subtraction imaging. Radiation Dosimetry Table 4 Radiation Dose Estimates for Thallous Chloride Tl 201 Injection (plus contaminants) Estimate Radiation Dose Organ MGy/MBq Rad/mCi Adrenals .065 0.24 Brain .061 0.22 Breasts .036 0.13 GB Wall .084 0.31 LLI Wall .34 1.3 Small Intestine .45 1.7 Stomach .19 0.69 ULI .33 1.2 Heart Wall .28 1.0 Kidneys .46 1.7 Liver .099 0.37 Lungs .048 0.18 Muscle .047 0.17 Ovaries .10 0.38 Pancreas .075 0.28 Marrow .056 0.21 Bone Surfaces .089 0.33 Skin .034 0.13 Spleen .18 0.66 Testes .83 3.1 Thymus .047 0.17 Thyroid .62 2.3 Urinary Bladder wall .053 0.20 Uterus .086 0.32 Effective Dose Equiv. .36 mSv/MBq 1.3 rem/mCi Based on data gathered in humans by Krahwinkel et al. (J Nucl Med 29(9):1582-1586, 1988) and data gathered in humans by Gupta et al. (Int J Nucl Med & Biol 8:211-213, 1981). Bladder voiding interval 4.8hr. Contaminants assumed: TI-200 (0.3%), TI-202 (0.84%), Pb-203 (0.2%). Includes dose from TI-201 Auger electrons. Estimate calculated using phantom of Cristy & Eckerman (Report ORNL/TM-8381/V1 & V7). Radiation Internal Dose Information Center.
Pregnancy and lactation
Nursing Mothers It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, nursing should not be undertaken when a patient is administered radioactive material.

More information

Category Value
Authorisation number NDA017806
Agency product number 3I8Y076A0E
Orphan designation No
Product NDC 11994-427
Date Last Revised 03-05-2018
Type HUMAN PRESCRIPTION DRUG
Marketing authorisation holder Lantheus Medical Imaging, Inc.