Iobenguane I 131 (eye-oh-BEN-gwane I 131)

Given during a scan or x-ray to help show tumors more clearly. Also treats metastatic pheochromocytoma or paraganglioma.

Brand Name(s):

Azedra

When This Medicine Should Not Be Used:

How to Use This Medicine:

Injectable

• Your doctor will prescribe your dose and schedule. This medicine is given through a needle placed in a vein.
• A nurse or other health provider will give you this medicine.
• Drink at least 2 liters of water a day, starting at least 1 day before and continuing for 1 week after each dose of Azedra®, so you will pass more urine. This will help flush the medicine from your body.
• You may also be given anti-vomiting medicine 30 minutes before receiving Azedra® and iodine at least 24 hours before and up to 10 days after each dose.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Some medicines can affect how this iobenguane I 131 works. Tell your doctor if you are using any of the following:
  • Cocaine, dextroamphetamine, ephedra, ma huang, methylphenidate, phentermine, St John's Wort, tramadol, yohimbine
  • Blood pressure medicine (including diltiazem, labetalol, nifedipine, reserpine, verapamil)
  • Cough or cold medicine (including ephedrine, phenylephrine, phenylpropanolamine, pseudoephedrine, naphazoline)
  • Medicine to treat depression (including MAO inhibitors, SNRIs, TCAs)
  Do not use these medicines until at least 7 days after each dose of iobenguane I 131.

Warnings While Using This Medicine:

• This medicine may cause birth defects if either partner is using it during conception or pregnancy. Tell your doctor right away if you or your partner becomes pregnant. Use an effective form of birth control during treatment with this medicine and for 7 months after the last dose. Male patients with female partners should use an effective form of birth control during treatment and for 4 months after the last dose.
• Do not breastfeed during treatment with Azedra® and for 80 days after the last dose.
• Tell your doctor if you have kidney disease or high blood pressure, or if you are on a low-sodium diet.
• This medicine may cause the following problems:
  • Increased risk for other cancer (including myelodysplastic syndrome, leukemia)
  • Thyroid problems
  • High blood pressure
  • Kidney problems
  • Pneumonitis (swelling of the lungs)
• You will be exposed to radiation when you receive this medicine. Talk to your doctor if you have concerns about this.
• This medicine may make you bleed, bruise, or get infections more easily. Take precautions to prevent illness and injury. Wash your hands often.
• This medicine could cause infertility. Talk with your doctor before using this medicine if you plan to have children.
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Bloody urine, change in how much or how often you urinate
• Chest pain, troubled breathing
• Dizziness, headache, blurred vision
• Fever, chills, cough, sore throat, body aches
• Unusual bleeding, bruising, or weakness
• Weight gain, dry skin and hair, muscle cramp or stiffness, slow heartbeat, feeling cold

If you notice these less serious side effects, talk with your doctor:

• Dry mouth, constipation, diarrhea
• Pain, itching, burning, redness, swelling, or a lump under your skin where the needle is placed
• Stomach pain or discomfort

If you notice other side effects that you think are caused by this medicine, tell your doctor

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