Pronunciation:

THAL-us KLOR-ide TI 201

Uses of This Medicine:

Thallous chloride Tl 201 injection is used in adults to help diagnose heart disease (eg, coronary artery disease, heart attack). It is used in certain procedures called planar scintigraphy or single-photon emission computed tomography (SPECT). This medicine shows how much blood is getting to your heart muscle when you are resting or exercising (stressed). Thallous chloride Tl 201 belongs to the group of medicines called radiopharmaceuticals (radioactive agents).

This medicine is also used to help diagnose parathyroid problems.

This medicine is to be given only by or under the direct supervision of a doctor with specialized training in nuclear medicine.

Before Using This Medicine:

In deciding to use a diagnostic test, any risks of the test must be weighed against the good it will do. This is a decision you and your doctor will make. Also, other things may affect test results. For this test, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies have not been performed on the relationship of age to the effects of thallous chloride Tl 201 injection in the pediatric population. Safety and efficacy have not been established.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of thallous chloride Tl 201 injection in the elderly. However, elderly patients are more likely to have age-related liver, kidney, or heart problems, which may require caution and an adjustment in the dose for patients receiving thallous chloride Tl 201 injection.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other medical problems—

The presence of other medical problems may affect the use of this diagnostic test. Make sure you tell your doctor if you have any other medical problems, especially:

• Breathing or lung problems (eg, bronchoconstriction) or
• Heart attack, history of or
• Heart rhythm problems (eg, arrhythmia) or
• Hypertension (high blood pressure) or
• Hypotension (low blood pressure) or
• Stroke, history of—Use with caution. May make these conditions worse.

Proper Use of This Medicine:

A doctor or other trained health professional will give you this medicine. This medicine is given through a needle placed in one of your veins just before you have a planar scintigraphy or SPECT scan.

Your doctor may ask you not to eat or drink anything for several hours before your test.

You may be asked to sit upright while you receive your injection.

Your planar scintigraphy or SPECT scan will be performed within 10 to 20 minutes after you receive this medicine.

Precautions While Using This Medicine:

It is very important that your doctor check your progress very closely while you are receiving this medicine. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to receive it.

You may receive a medicine to make your heart beat faster. This is called a pharmacologic stress test. It is used together with the planar scintigraphy or SPECT scan to show how well your heart muscle works when it is stressed. Talk to your doctor if you have questions about this test.

This medicine may cause a serious type of allergic reaction called anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Check with your doctor or nurse right away if you have cold, clammy skin, confusion, dizziness, lightheadedness, a skin rash, itching, sweating, swelling of the face, tongue, and throat, trouble with breathing, warmth or redness in your face, neck, arms, or upper chest, or chest pain after you receive the medicine.

Tell your doctor right away if you have mild, burning pain, feeling of warmth or coldness, or redness at the injection site.

While receiving this medicine, you will be exposed to radiation. If you have any questions about this, talk to your doctor.

The vial stopper contains dry natural rubber (a derivative of latex), which may cause allergic reactions in people who are sensitive to latex. Tell your doctor if you have a latex allergy before receiving this medicine.

It is important to tell your doctor that you are pregnant before receiving this medicine.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur:

Incidence not known

Blurred vision

chest pain or discomfort

chills

confusion

cough

difficulty with breathing

difficulty with swallowing

dizziness

dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position

fainting

fast, slow, or irregular heartbeat

feeling of warmth

fever

hives, itching, or skin rash

inability to speak

nausea

noisy breathing

pain or discomfort in the arms, jaw, back, or neck

puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue

redness of the face, neck, arms, and occasionally, upper chest

seizures

severe or sudden headache

shakiness in the legs, arms, hands, or feet

slurred speech

sweating

temporary blindness

tightness in the chest

trembling or shaking of the hands or feet

unusual tiredness or weakness

vomiting

weakness in the arm or leg on one side of the body, sudden and severe

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Incidence not known

Bleeding, blistering, burning, coldness, discoloration of the skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site

burning, dry, or itching eyes

discharge or excessive tearing

mild diarrhea

redness, pain, or swelling of the eye, eyelid, or inner lining of the eyelid

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.