Consumer medicine information

THALLIUM CHLORIDE T1 201 INJECTION USP

Thallous chloride Tl 201

BRAND INFORMATION

Brand name

Lantheus Thallium (201TI) Chloride Injection

Active ingredient

Thallous chloride Tl 201

Schedule

Unscheduled

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using THALLIUM CHLORIDE T1 201 INJECTION USP.

What is in this leaflet

This leaflet answers some of the common questions about Thallous Chloride Tl 201. It does not contain all of the available information about Thallous Chloride Tl 201. It does not replace talking to your doctor.

All medicines have risks and benefits. Your doctor has weighed the risks of you receiving Thallous Chloride Tl 201 against the benefits he or she expects it will have.

If you have any concerns about having this medicine, ask your doctor.

Keep this leaflet. You may need to read it again.

What is Thallous Chloride Tl 201

Thallous Chloride Tl 201 Injection contains an isotope of the element Thallium and belongs to a group of medicines called radiopharmaceutical agents, which are all radioactive.

What Thallous Chloride Tl 201 is used for

Thallous Chloride Tl 201 is used to show the blood flow inside your heart during exercise and rest.

Thallous Chloride Tl 201 can be used to show areas of increased activity in the parathyroid glands. Your parathyroid glands are situated in your neck.

Your doctor may have prescribed Thallous Chloride Tl 201 for another purpose. Ask your doctor if you have any questions about why Thallous Chloride Tl 201 has been prescribed for you. If you have any concerns, you should discuss these with your doctor.

This medicine is only available with a doctor’s prescription.

Before you are given Thallous Chloride Tl 201

Before you are given Thallous Chloride Tl 201 your doctor will explain to you the procedure you are about to undergo, and the radioactive medicine you will be given. You must discuss any concerns you have with your doctor.

Thallous Chloride Tl 201 is not recommended for patients less than 18 years of age. If your doctor believes it is necessary to give Thallous Chloride Tl 201 to a patient under 18, he or she will discuss the benefits and risks with you.

You must tell your doctor if you have allergies to:

  • any other medicines
  • any other substances such as foods, preservatives or dyes

Tell your doctor if you are or plan to become pregnant. Like most medicines Thallous Chloride Tl 201 is not recommended for use during pregnancy. If there is a need to consider Thallous Chloride Tl 201 during your pregnancy, your doctor will discuss the benefits and risks of giving it to you. If you are given Thallous Chloride Tl 201 when you are pregnant, your developing baby will be exposed to the radiation.

Tell your doctor if you are breastfeeding or plan to breastfeed. Like most medicines Thallous Chloride Tl 201 is not recommended while you are breastfeeding. However if you are breastfeeding, formula feedings should be substituted for breastfeeding for 24 hours following the administration of Thallous Chloride Tl 201. Breast milk produced within that time should be discarded.

Tell your doctor if you have any other medical conditions, especially if you suffer from heart disease or from diabetes.

Taking other medicines

Tell your doctor if you are taking any other medicines, including medicines that you buy without a prescription from pharmacy, supermarket or health food shop.

How Thallous Chloride Tl 201 is given

How much is given

Your doctor will decide how much you will be given.

If you are receiving Thallous chloride Tl 201 to get an image of your heart you will receive only one injection. If you are receiving Thallous chloride to get an image of your parathyroid glands you may receive an injection of another imaging agent - Tc99m, 20 minutes after the Thallous chloride Tl 201 to give a better image of your parathyroids.

How it is given

Thallous Chloride Tl 201 is given as an injection into a vein. Thallous Chloride Tl 201 should only be given by a doctor or a nurse.

When you are given Thallous Chloride Tl 201

Things you must do

You must drink about 2 litres of fluid and void urine frequently immediately after the procedure. This will remove as much radioactivity as possible from your bladder.

Things you must not do

Do not take any other medicines until advised by your doctor.

Things to be careful of

Do not drive or operate machinery until you know how Thallous Chloride Tl 201 affects you. Thallous Chloride Tl 201 may cause dizziness in some people. Make sure you know how you react to Thallous Chloride Tl 201 before you drive a car, operate machinery or do anything else that could be dangerous if you are dizzy.

Side effects

Tell your doctor as soon as possible if you do not feel well after being given Thallous Chloride Tl 201.

Tell your doctor or a nurse immediately if you notice any of the following:

  • dizziness
  • light-headedness
  • itchiness
  • rash

Product description

What it looks like

Thallous Chloride Tl 201 is a clear solution supplied in vials. An injection is prepared from the vial immediately before it is injected.

Ingredients

Active ingredient: Thallium Tl 201.

Inactive Ingredients: sodium chloride, benzyl alcohol

Sponsor

Lantheus MI Australia Pty Ltd
Unit8/24-26 Carrick Drive
Tullamarine
Victoria 3043

Registration Number

AUST R 112603

Date of Preparation

Updated: April 2012.

Published by MIMS January 2015

BRAND INFORMATION

Brand name

Lantheus Thallium (201TI) Chloride Injection

Active ingredient

Thallous chloride Tl 201

Schedule

Unscheduled

 

1 Name of Medicine

Thallous (201Tl) chloride.

2 Qualitative and Quantitative Composition

Thallous Chloride Tl 201 Injection for intravenous administration is supplied as a sterile, nonpyrogenic isotonic solution containing 74 MBq/mL of Thallous Chloride Tl 201 at calibration time. It is made isotonic with 9 mg/mL sodium chloride and is preserved with 9 mg/mL of benzyl alcohol. The pH is adjusted to between 4.5-7.5 with hydrochloric acid and/or sodium hydroxide solution.
Thallium Tl 201 is cyclotron produced with no carrier added and contains no less than 98% Thallium Tl 201 as a percentage of total activity with contaminants not greater than 0.3% Thallium Tl 200, 0.84% Thallium Tl 202, and 0.2% Lead Pb 203 expressed as a percentage of Tl 201 activity at calibration.

3 Pharmaceutical Form

Clear and colourless solution for intravenous injection.

4 Clinical Particulars

4.1 Therapeutic Indications

Thallous Chloride Tl 201 Injection may be useful in myocardial perfusion imaging and for the diagnosis and localization of myocardial infarction.
It may also be useful in conjunction with exercise stress testing as an adjunct to the diagnosis of ischemic heart disease.
Thallous Chloride Tl 201 Injection may be useful for the localization of areas of parathyroid hyperactivity and for parathyroid imaging in patients with biochemically proven hyperparathyroidism.

4.2 Dose and Method of Administration

The recommended adult (70 kg) dose of intravenous Thallous Chloride Tl 201 Injection is 37 to 74 MBq. Thallous Chloride Tl 201 Injection is intended for intravenous administration only.
As for all parenteral drug products, contents of the vial should be inspected visually for particulate matter and discoloration prior to administration.
The patient dose should be measured by a suitable radioactivity calibration system immediately prior to administration.

Myocardial imaging.

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 Tl 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 postinjection 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. Usually 10 minute images are obtained in the anterior and left anterior oblique (45°-75°) positions. Gated images may also be obtained.

Parathyroid imaging.

Parathyroid imaging is accomplished by a dual tracer technique using Tl 201 as thallous chloride for thyroid and parathyroid imaging, and Tc99m as sodium pertechnetate for thyroid imaging. Data is acquired using a gamma camera equipped with pinhole collimator and with on-line computer facilities. Patients are given an I.V. injection of 37-74 MBq of Thallous Chloride Tl 201 Injection. Anterior images are dynamically obtained for 30 minutes using the 65-80.3 keV photopeak. Patients are then given 37 MBq of Tc99m sodium pertechnetate and 20 minutes later a 500,000 count anterior image of the thyroid is taken for five minutes followed by a five minute image of the Tc99m scatter in the Tl 201 window setting.
The technetium image is then subtracted from the normalized thallium images to locate areas of increased thallium uptake. Positive scintigrams demonstrate either focal uptake of Tl 201 in extrathyroidal site or an intrathyroidal area of relatively high Tl 201 uptake and diminished Tc99m uptake.

Radiation dosimetry.

See Table 1.
The patient dose should be measured by a suitable radioactivity calibration system immediately prior to administration.
Thallous Chloride Tl 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.

Preparation and handling procedures for Thallous Chloride Tl 201 Injection.

a. Waterproof gloves should be worn during the handling and injection.
b. Adequate shielding during the life of the radioactive drug should be maintained by using the lead shield and cover and by using a syringe shield for withdrawing and injecting Thallous Chloride Tl 201 Injection.
The contents of this vial are radioactive and adequate shielding and handling precautions must be maintained.
It is recommended that Thallous Chloride Tl 201 Injection be administered close to calibration time to minimize the effect of higher levels of radionuclide contaminants pre- and postcalibration. The concentration of each radionuclide contaminant changes with time. Figure 1 shows maximum concentration of each radionuclidic contaminant as a function of time.

4.3 Contraindications

None known.

4.4 Special Warnings and Precautions for Use

In studying patients in whom myocardial infarction or ischemia is known or suspected, care should be taken to assure continuous clinical monitoring and treatment in accordance with safe, accepted procedure. Exercise stress testing should be performed only under the supervision of a qualified physician and in a laboratory equipped with appropriate resuscitation and support apparatus.
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 Tl 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.
Ideally, examination using radiopharmaceuticals, especially those elective in nature, of a woman of childbearing capability should be performed during the first few (approximately 10) days following the onset of menses.
Radiopharmaceuticals should be used only by physicians who are qualified by training and experience in the safe use and handling of radionuclides and whose experience and training have been approved by the appropriate government agency authorized to license the use of radionuclides.
Radiopharmaceuticals should be administered, received and used by medical practitioners who are qualified and licensed to handle radio isotopes. Their receipt, storage, use, transfer and disposal are subject to the regulations and/or appropriate licenses of the local competent official organizations.
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 be taken to minimize radiation exposure to patients in a manner consistent with proper patient management.
The administration of radiopharmaceuticals creates risks for other persons from external radiation or contamination from spills of urine, vomiting, etc. Radiation protection precautions in accordance with the national regulations must be taken.

Use in the elderly.

No data available.

Pediatric use.

Safety and effectiveness in children below the age of 18 have not been established.

Effects on laboratory tests.

No data available.

4.5 Interactions with Other Medicines and Other Forms of Interactions

The potential risk to the patient must be considered before withdrawing any existing drug treatment in the interests of test accuracy.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

When it is necessary to administer radioactive medicinal products to women of childbearing potential, information should always be sought about pregnancy. Any woman who has missed a period should be assumed to be pregnant until proven otherwise. Where certainty exists it is important that radiation exposure should be the minimum consistent with achieving the desired clinical information.
No long term animal studies have been performed to evaluate whether Thallous Chloride Tl 201 Injection affects fertility in males or females. Animal studies indicate that Thallous Chloride Tl 201 Injection accumulates in the testes. The significance of this observation is not clear.
Adequate reproductive studies have not been conducted in animals with Thallous Chloride Tl 201 Injection. It is also not known whether Thallous Chloride Tl 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.
Radionuclide procedures carried out on pregnant women also involve radiation doses to the foetus.
 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.
Before administering a radioactive product to a mother who is breast feeding, consideration should be given as to whether the investigation could be reasonably delayed until the mother has ceased breastfeeding and as to whether the most appropriate choice of radiopharmaceutical has been made, bearing in mind the secretion of activity in breast milk. If the administration is considered necessary, breastfeeding should be interrupted and the expressed feeds discarded. Breastfeeding can be restarted when the level in the milk will not result in a dose to the child greater than 1 mSv.

4.7 Effects on Ability to Drive and Use Machines

The effects of this medicine on a person's ability to drive and use machines were not assessed as part of its registration.

4.8 Adverse Effects (Undesirable Effects)

A single adverse reaction to the administration of Thallous Chloride Tl 201 Injection has been reported consisting of hypotension accompanied by pruritus and a diffuse rash which responded to antihistamines and steroids within one hour.

Reporting suspected adverse effects.

Reporting suspected adverse reactions after registration of the medicinal product is important. It allows continued monitoring of the benefit-risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions at https://www.tga.gov.au/reporting-problems.

4.9 Overdose

For information on the management of overdose, contact the Poisons Information Centre on 13 11 26 (Australia).

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Mechanism of action.

In clinical studies, thallium images have been found to visualize areas of infarction as "cold" or nonlabeled regions which are confirmed by electrocardiographic and enzyme changes. Regions of transient myocardial ischemia corresponding to areas perfused by coronary arteries with partial stenoses have been visualized when Thallous Chloride Tl 201 Injection was administered in conjunction with an exercise stress test.

Clinical trials.

No data available.

5.2 Pharmacokinetic Properties

Absorption.

In clinical studies, thallium images have been found to visualize areas of infarction as "cold" or nonlabeled regions which are confirmed by electrocardiographic and enzyme changes.

Distribution.

Thallous Chloride Tl 201 Injection with no carrier added has been found to accumulate in viable myocardium in a manner analogous to that of potassium. Experiments in employing labeled microspheres in human volunteers have shown that the myocardial distribution of Thallous Chloride Tl 201 correlates well with regional perfusion.

Metabolism.

After intravenous administration, Thallous Chloride Tl 201 clears rapidly from the blood with the greatest accumulation in the kidneys, and normal myocardium, followed by the thyroid, small intestine and liver. Parathyroid adenomas have also been shown to concentrate Tl 201 as well. The combined imaging with Tl 201 and Sodium Pertechnetate Tc 99m Injection provides preoperative localization information to areas of parathyroid hyperactivity.

Excretion.

After intravenous administration, Thallous Chloride Tl 201 clears rapidly from the blood with maximal concentration by normal myocardium occurring at about ten minutes.

5.3 Preclinical Safety Data

Genotoxicity.

No data available.

Carcinogenicity.

No long-term animal studies have been performed to evaluate carcinogenic potential, mutagenic potential.

6 Pharmaceutical Particulars

6.1 List of Excipients

See Section 2 Qualitative and Quantitative Composition.

6.2 Incompatibilities

Incompatibilities were either not assessed or not identified as part of the registration of this medicine.

6.3 Shelf Life

Expiry 5 days.
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.

6.4 Special Precautions for Storage

Store below 25°C.

6.5 Nature and Contents of Container

Vials are available in the following quantities of radioactivity: 162.8, 244.2, 325.6, 407.0, 569.8 and 732.6 MBq of Thallous Chloride Tl 201.

6.6 Special Precautions for Disposal

In Australia, any unused medicine or radioactive waste material should be disposed of in accordance with Code for the disposal of radioactive wastes by the user, which is published on the Australian Radiation Protection and Nuclear Safety Agency (ARPANSA) website as Radiation Protection Series (RPS C-6).

6.7 Physicochemical Properties

Physical characteristics.

Thallium Tl 201 decays by electron capture to stable Mercury Hg 201 with a physical half life of 73.1 hours. Photons that are useful for detection and imaging are listed in Table 2. The lower energy X-rays obtained from the Mercury Hg 201 daughter of Tl 201 are recommended for imaging. See Table 2.

External radiation.

The specific gamma ray constant for Thallium Tl 201 is 120 microGy/MBq-hr at 1 cm. Attenuation by lead is given in Table 3.
To correct for physical decay of this radionuclide, the fractions that remain at selected intervals after calibration are shown in Table 4.

CAS number.

7791-12-0.

7 Medicine Schedule (Poisons Standard)

Unscheduled.

Summary Table of Changes