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Description

Iobenguane I 123 is a radiopharmaceutical. Radiopharmaceuticals are radioactive agents, which may be used to find and treat certain diseases or to study the function of the body's organs.

Iobenguane I 123 is used to find certain kinds of cancer of the adrenal glands.

When very small doses of iobenguane I 123 are given, the radioactivity taken up by the adrenal gland helps find tumors of the adrenal glands. An image of the gland on film or on a computer screen can be provided to help with the diagnosis.

Iobenguane I 123 is to be given only by or under the direct supervision of a doctor with specialized training in nuclear medicine.

Before Using

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.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of iobenguane I 123 in infants below 1 month of age. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of iobenguane I 123 in the elderly. However, elderly patients are more likely to have age-related kidney, liver, or heart problems, which may require an adjustment in the dose for patients receiving iobenguane I 123.

Pregnancy

Breastfeeding

Studies in women breastfeeding have demonstrated harmful infant effects. An alternative to this medication should be prescribed or you should stop breastfeeding while using this medicine.

Drug Interactions

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:

• Hypertension (high blood pressure) or
• Thyroid problems—Use with caution. May make these conditions worse.

• Kidney disease, severe—Use with caution. The effects of this medicine may be increased because of slower removal from the body.

Proper Use

Your doctor or other trained health professional will give you this medicine. This medicine is given through a needle placed in one of your veins.

Precautions

It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly.

This medicine contains benzyl alcohol which may cause serious reactions to premature or low-birthweight infants. Discuss this with your doctor if you are concerned.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Side Effects

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:

• Difficulty in breathing and/or swallowing
• Fever
• Hives
• Nausea
• Reddening of the skin, especially around ears swelling of eyes, face, or inside of nose
• Unusual tiredness or weakness

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:

• Bleeding, blistering, burning, coldness, discoloration of skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at site
• Dizziness
• Feeling of warmth or redness of the face, neck, arms and occasionally, upper chest
• Skin rash or itching

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.

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