Iobenguane i 131 (Intravenous)

Iobenguane I 131 injection is a radiopharmaceutical. Radiopharmaceuticals are radioactive substances that can be used to locate and treat certain diseases or to examine how the body's organs work.

Iobenguane I 131 injection is used to treat iobenguane scan positive, advanced or metastatic pheochromocytoma (cancer of the adrenal glands) or paraganglioma in patients who cannot have surgery and need systemic cancer treatment.

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

This medicine must be given only by or under the direct supervision of a doctor who has specialized training in nuclear medicine or radiation oncology.

It is very important for your doctor to check you and your child's progress at regular visits to ensure 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 mainly passed in the urine where radioactivity is present. Follow these guidelines after receiving iobenguane I 131 injection to help reduce the chance of contaminating other people 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, wash 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 (e.g., ma huang, St. John’s Wort, yohimbine) or vitamin supplements.

In deciding to use a medicine, you and your doctor will weigh the risks against the benefits. For this medicine, please consider the following:

Allergies

Inform your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also, let your healthcare professional know if you have any other allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Studies have not shown any specific problems that would limit the usefulness of iobenguane I 131 injection in children 12 years of age and older. Safety and effectiveness have been confirmed.

Geriatric

Studies have not indicated any specific problems that would limit the usefulness of iobenguane I 131 injection in older adults.

Breast Feeding

There are no adequate studies in women to determine any risk to infants when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Some medicines should not be used together, while others may be prescribed together even if an interaction might happen. In these cases, your doctor may adjust the dose or take other precautions. It is very important for your healthcare professional to know if you are taking any of the medicines listed below while receiving this medicine. The following interactions are based on 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 necessary 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

Interactions with Food/Tobacco/Alcohol

Some medicines should not be taken around the time of eating food or certain types of food due to potential interactions. Using alcohol or tobacco with certain medicines may also cause interactions. Talk to your healthcare professional about how to use your medicine with food, alcohol, or tobacco.

Other Medical Problems

Other medical problems may affect the use of this medicine. Be sure to tell your doctor if you have any other medical issues, especially:

• Hypertension (high blood pressure) or
• Hypothyroidism (underactive thyroid)—Use with caution. This may worsen these conditions.

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

• Kidney disease, mild or moderate—Use with caution. The effects may be stronger because the body removes the medicine more slowly.

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

Check with your doctor or nurse right away 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 happen that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your healthcare professional may be able to tell you ways to prevent or reduce some of these side effects. Check with your healthcare 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 happen 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.

In the U.S.

• Azedra

Available Dosage Forms:

• Solution

Therapeutic Class: Diagnostic Agent, Radiopharmaceutical Imaging

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.