Pronunciation:

eye-oh-BEN-gwane I 131

Brand Names:

• Azedra

Dosage Forms:

• Solution

Classifications:

Therapeutic—

Diagnostic Agent, Radiopharmaceutical Imaging

Uses of This Medicine:

Iobenguane I 131 injection is a radiopharmaceutical. Radiopharmaceuticals are radioactive agents that may be used to find and treat certain diseases or to study the function of the body's organs.

Iobenguane I 131 injection is used to treat iobenguane scan positive, advanced or metastatic (cancer that has spread) pheochromocytoma (cancer of the adrenal glands) or paraganglioma in patients who cannot be treated by surgery and who require systemic cancer treatment.

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

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

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, 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 performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of iobenguane I 131 injection in children 12 years of age and older. Safety and efficacy have been established.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of iobenguane I 131 injection in the elderly.

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. When you are receiving this medicine, 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.

Using this medicine 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.

• Amineptine
• Amitriptyline
• Amitriptylinoxide
• Amoxapine
• Amphetamine
• Apraclonidine
• Armodafinil
• Benzphetamine
• Brimonidine
• Bupropion
• Caffeine
• Carteolol
• Carvedilol
• Citalopram
• Clomipramine
• Clonidine
• Cocaine
• Desipramine
• Desvenlafaxine
• Dexmedetomidine
• Dexmethylphenidate
• Dextroamphetamine
• Dibenzepin
• Diethylpropion
• Doxepin
• Duloxetine
• Ephedrine
• Escitalopram
• Fluoxetine
• Fluvoxamine
• Furazolidone
• Guanabenz
• Guanfacine
• Imipramine
• Iproniazid
• Labetalol
• Levobunolol
• Levomilnacipran
• Linezolid
• Lisdexamfetamine
• Lofepramine
• Lofexidine
• Ma Huang
• Mazindol
• Melitracen
• Methamphetamine
• Methoxamine
• Methyldopa
• Methylene Blue
• Methylphenidate
• Metipranolol
• Metyrosine
• Midodrine
• Milnacipran
• Moclobemide
• Modafinil
• Nadolol
• Naphazoline
• Nefazodone
• Nialamide
• Nortriptyline
• Opipramol
• Oxprenolol
• Paroxetine
• Pemoline
• Penbutolol
• Phendimetrazine
• Phenelzine
• Phenmetrazine
• Phentermine
• Phenylephrine
• Pindolol
• Practolol
• Procarbazine
• Propranolol
• Protriptyline
• Pseudoephedrine
• Rasagiline
• Reserpine
• Safinamide
• Selegiline
• Sertraline
• Sibutramine
• Sotalol
• St John's Wort
• Tetrabenazine
• Tianeptine
• Timolol
• Tranylcypromine
• Trimipramine
• Venlafaxine
• Vilazodone
• Vortioxetine

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 medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Hypertension (high blood pressure) or
• Hypothyroidism (underactive thyroid)—Use with caution. May make these conditions worse.

• Infection—May decrease your body's ability to fight an infection.

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

Proper Use of This Medicine:

A nurse or other trained health professional will give you this medicine in a medical facility. This medicine is given through a needle placed into one of your veins.

Drink at least 2 liters of water a day, starting at least 1 day before and continuing for 1 week after each dose of this medicine.

You may also be given anti-vomiting medicine 30 minutes before receiving this medicine and iodine at least 24 hours before and up to 10 days after each dose of this medicine.

Precautions While Using This Medicine:

It is very important that your doctor check you and your child's progress at regular visits to make sure this medicine is working properly. Blood and urine tests may be needed to check for unwanted effects.

Receiving this medicine while you are pregnant can harm your unborn baby. It may also cause birth defects if the father is receiving it when his sexual partner becomes pregnant. Female patients should use effective birth control during treatment with this medicine and for 7 months after the last dose. Male patients who have female partners should use effective birth control during treatment with this medicine and for 4 months after the last dose. If you think you have become pregnant while receiving this medicine, tell your doctor right away.

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

This medicine is passed mainly in the urine where radioactivity is present. Follow these guidelines after receiving iobenguane I 131 injection, to help reduce the chance of contaminating other persons or the environment with radiation:

• Use a normal toilet, if available, instead of a urinal.
• To prevent contamination of your home environment, flush the toilet several times after using.
• Wipe any spilled urine with a tissue and flush it away.
• Wash your hands after using or cleaning the toilet.
• Wash your clothes and bed linens right away if they become soiled with your urine or blood. Wash them separately from other clothes.
• If you cut yourself, was h away any spilled blood.

This medicine may lower the number of some types of blood cells in your body. Because of this, you or your child may bleed or get infections more easily. To help with these problems, avoid being near people who are sick or have infections. Wash your hands often. Stay away from rough sports or other situations where you could be bruised, cut, or injured. Brush and floss your teeth gently. Be careful when using sharp objects, including razors and fingernail clippers.

Check with your doctor right away if you or your child have bloody urine, a decrease in frequency or amount of urine, an increase in blood pressure, increased thirst, loss of appetite, lower back or side pain, nausea, swelling of the face, fingers, or lower legs, troubled breathing, unusual tiredness or weakness, vomiting, or weight gain. These could be symptoms of a serious kidney problem.

This medicine may cause swelling of the lungs (pneumonitis), which can be life-threatening and requires immediate medical attention. Check with your doctor right away if you or your child have new or worsening cough, fever, or trouble breathing.

If you plan to have children, talk with your doctor before receiving this medicine. Some men and women receiving this medicine have become infertile (unable to have children).

Do not take other medicines until at least 7 days after each dose of iobenguane I 131 injection or unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal (eg, ma huang, St. John’s Wort, yohimbine) or vitamin supplements.

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:

More common

Black, tarry stools

bladder pain

bleeding gums

bleeding under the skin

blood in the urine or stools

blurred vision

body aches or pain

chest pain

chills

cloudy urine

confusion

cough

decreased frequency or amount of urine

difficult or labored breathing

difficult, burning, or painful urination

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

dry mouth

ear congestion

fast, pounding, or irregular heartbeat or pulse

fever

frequent urge to urinate

headache

heartburn

hoarseness

increased thirst

loss of appetite

loss of voice

lower back or side pain

nasal congestion

nausea

nervousness

nosebleed

pale skin

pinpoint red spots on the skin

pounding in the ears

rapid breathing

runny nose

slow heartbeat

sneezing

sore throat

sunken eyes

swelling of the face, fingers, or lower legs

tightness in the chest

troubled breathing with exertion ulcers, sores, or white spots in the mouth

unusual bleeding or bruising

unusual tiredness or weakness

vomiting

weight gain

wrinkled skin

Less common

Constipation

depressed mood

dry skin and hair

feeling cold

hair loss

muscle cramps and stiffness

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:

More common

Back pain

belching

change in taste

decreased weight

diarrhea

difficulty in moving

increased sweating

indigestion

joint pain

loss of taste mouth, throat, or jaw pain

muscle pain, spasm, or stiffness

neck pain

pain at the injection site

pain in the arms or legs

rash

stomach discomfort, upset, or pain

stomach distension

tenderness of the salivary glands

thinning of the hair

trouble sleeping

trouble swallowing

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.