Brand Name

    US Brand Name

    AdreView


    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 (eg, pheochromocytoma, neuroblastoma). 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 also used during a test for patients with congestive heart failure. This may help the doctor see certain heart problems.

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

    This product is available in the following dosage forms:

    • Solution

    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 children with neuroblastoma younger than 1 month of age, or in children of any age with congestive heart failure. Safety and efficacy have not been established in these populations.

    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 problems, which may require caution and an adjustment in the dose for patients receiving iobenguane I 123.

    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. When you are receiving this diagnostic test, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

    Receiving this diagnostic test with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

    • Albuterol
    • Amineptine
    • Amitriptyline
    • Amitriptylinoxide
    • Amoxapine
    • Bambuterol
    • Bupropion
    • Butriptyline
    • Carvedilol
    • Citalopram
    • Clomipramine
    • Cocaine
    • Desipramine
    • Desvenlafaxine
    • Dibenzepin
    • Dothiepin
    • Doxepin
    • Duloxetine
    • Ephedrine
    • Epinephrine
    • Escitalopram
    • Fluoxetine
    • Fluvoxamine
    • Furazolidone
    • Guanethidine
    • Imipramine
    • Iprindole
    • Iproniazid
    • Isocarboxazid
    • Isoproterenol
    • Labetalol
    • Linezolid
    • Lofepramine
    • Melitracen
    • Metaproterenol
    • Methylene Blue
    • Metyrosine
    • Midodrine
    • Milnacipran
    • Moclobemide

    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:

    • Allergy to iodine, an iodine-containing contrast agent (dye), or other products containing iodine (eg, potassium iodide or Lugol's solution), history of—May increase risk of an allergic reaction to occur again.
    • 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.

    Drink extra fluids before receiving this medicine so you will pass more urine. You should void frequently for the first 48 hours after receiving this medicine.


    Precautions

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

    You will be exposed to radiation when you are given this medicine. Talk with your doctor if you have concerns about this.

    This medicine may cause a serious type of allergic reaction called anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Tell your doctor right away if you have a rash, itching, swelling of the face, tongue, and throat, trouble breathing, or chest pain after you receive this medicine.

    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:

    Incidence not known

    • Difficulty breathing or swallowing
    • fast heartbeat
    • fever
    • hives
    • hoarseness
    • irritation
    • itching
    • joint pain, stiffness, or swelling
    • nausea
    • rash
    • reddening of the skin, especially around the ears
    • swelling of the eyes, face, or inside of the nose
    • tightness in the chest
    • 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:

    Less common

    • Bleeding, blistering, bruising, 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
    • dizziness
    • feeling of warmth or redness of the face, neck, arms, and occasionally, upper chest

    Rare

    • Headache

    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.






    CON-XXXXXXXX

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