Azedra Dosimetric

This medication is used to treat certain cancers (pheochromocytoma, paraganglioma). Iobenguane I 131 is a radioactive drug. It works by building up in certain cancer cells and causing them to die.

This medication is given by injection into a vein by a health care professional. It is given as directed by your doctor, usually 2 doses given at least 90 days apart.

The dosage is based on your medical condition, weight, lab tests, and response to treatment.

To decrease the risk of side effects, your doctor will prescribe other medications (such as drugs to prevent nausea) for you to use before each injection. Your doctor will also prescribe a drug to help protect your thyroid gland, starting 24 hours before and continuing for 10 days after each dose of this medication. To lessen damage to your bladder, drink at least 8 glasses (68 ounces/2 liters) of liquid daily, starting at least 1 day before and continuing for one week after each dose. Carefully follow all of your doctor's directions.

Dizziness, tiredness, headache, nausea, vomiting, diarrhea/constipation, abdominal pain, change in how food tastes, dry mouth, throat pain, or loss of appetite may occur. Nausea and vomiting can be severe. In some cases, your doctor may prescribe medication to prevent or relieve nausea and vomiting. Eating several small meals, not eating before treatment, or limiting activity may help lessen some of these effects. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

To reduce the risk of dizziness and lightheadedness, get up slowly when rising from a sitting or lying position.

To relieve dry mouth, suck (sugarless) hard candy or ice chips, chew (sugarless) gum, drink water, or use a saliva substitute.

Temporary hair loss may occur. Normal hair growth should return after treatment has ended.

People using this medication may have serious side effects. However, your doctor has prescribed this drug because he or she has judged that the benefit to you is greater than the risk of side effects. Careful monitoring by your doctor may decrease your risk.

This medication may raise your blood pressure. Check your blood pressure regularly and tell your doctor if the results are high.

Tell your doctor right away if you have any serious side effects, including: easy bruising/bleeding, signs of kidney damage (such as change in amount of urine).

This medication may lower your ability to fight infections. This may make you more likely to get a serious (rarely fatal) infection or make any infection you have worse. Tell your doctor right away if you have any signs of infection (such as sore throat that doesn't go away, fever, chills, cough).

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US - Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Before using iobenguane I 131, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney problems, thyroid disease, high blood pressure.

This medication can make you more likely to get infections or may worsen any current infections. Avoid contact with people who have infections that may spread to others (such as chickenpox, measles, flu). Consult your doctor if you have been exposed to an infection or for more details.

Do not have immunizations/vaccinations without the consent of your doctor. Avoid contact with people who have recently received live vaccines (such as flu vaccine inhaled through the nose).

To lower the chance of getting cut, bruised, or injured, use caution with sharp objects like razors and nail cutters, and avoid activities such as contact sports.

This drug may make you dizzy. Alcohol or marijuana (cannabis) can make you more dizzy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Limit alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis).

This medication may increase your risk for other cancers (such as myelodysplastic syndrome, leukemia). Talk to your doctor for details.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Children may be at greater risk for side effects of this drug.

This medication may affect the ability to have children. Talk to your doctor for details.

Tell your doctor if you are pregnant or plan to become pregnant. You should not become pregnant while using this medication. Iobenguane I 131 may harm an unborn baby. Males with female partners of childbearing age should ask about reliable forms of birth control while using this medication and for 4 months after stopping treatment. Women of childbearing age should ask about reliable forms of birth control while using this medication and for 7 months after stopping treatment. If you become pregnant, talk to your doctor right away about the risks and benefits of this medication.

It is unknown if this drug passes into breast milk. Because of the possible risk to the infant, breast-feeding is not recommended while using this drug and for 80 days after the last dose. Consult your doctor before breast-feeding.

Not applicable. This medication is given in a hospital or clinic or doctor's office and will not be stored at home.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

For the best possible benefit, it is important to receive each scheduled dose of this medication as directed. If you miss a dose, contact your doctor or pharmacist right away to establish a new dosing schedule. Do not double the dose to catch up.

Lab and/or medical tests (such as complete blood count, kidney/thyroid function, blood pressure) should be done while you are using this medication. Women of childbearing age should have a pregnancy test before starting this medication. Keep all medical and lab appointments.