Radium Ra 223 Dichloride, Injection

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KEY POINTS

• This medicine is given by IV to treat prostate cancer. For at least 1 week after treatment, you need to take radiation precautions to protect other people from being exposed to radiation.
• Use condoms and make sure female partners who may become pregnant use effective methods of birth control while you are receiving this medicine and for 6 months after therapy is completed.
• You may get infections more easily when you are taking this medicine.
• Keep all appointments for tests to see how this medicine affects you.
• This medicine may cause unwanted side effects. Tell your healthcare provider if you have any side effects that are serious, continue, or get worse.
• Tell all healthcare providers who treat you about all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take.

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What are other names for this medicine?

Type of medicine: antineoplastic (anticancer)

Generic and brand names: radium Ra 223 dichloride, injection; Xofigo

What is this medicine used for?

This medicine is given by IV injection to treat advanced prostate cancer that has spread to the bones. This medicine delivers radiation directly to cancer cells.

This medicine may be used to treat other conditions as determined by your healthcare provider.

What should my healthcare provider know before I take this medicine?

Before taking this medicine, tell your healthcare provider if you have ever had:

• An allergic reaction to any medicine
• Bleeding problems or blood disorders
• Bone marrow problems

Also, tell your healthcare provider if you are receiving any chemotherapy or radiation therapy.

Men who receive this medicine should use a condom when having sex with a woman who may become pregnant. Use condoms during treatment with this medicine and for 6 months after stopping treatment.

Females of childbearing age: This medicine is not given to women. Do not take this medicine if you are pregnant. This medicine has been reported to cause birth defects. Stop taking this medicine at the first sign that you may be pregnant and contact your healthcare provider right away. Do not breast-feed while taking this medicine. Use effective birth control methods while your partner is taking this medicine and for 6 months after stopping it. Ask your healthcare provider about effective methods of birth control. Do not breast-feed while taking this medicine.

How do I use it?

This medicine is given by IV infusion (slow drip into a large vein) by your healthcare provider. It is usually given over 1 minute every 4 weeks for 6 injections.

What should I watch out for?

For at least 1 week after each treatment, you need to take radiation precautions to protect other people from being exposed to radiation. Wash your hands with soap and water after handling bodily fluids and after going to the bathroom. Sit while urinating and flush the toilet 3 times with the lid down. Wipe any spilled urine or other bodily waste with tissue and flush, wearing gloves when you clean. Dispose of gloves as directed by your healthcare provider. Wash your clothes and eating utensils separately from those of other people.

Use condoms and make sure female partners who may become pregnant use effective methods of birth control while you are receiving this medicine and for 6 months after therapy is completed. Talk with your healthcare provider about this.

You will need to have lab tests regularly to see how this medicine affects you. Keep all appointments for tests.

You may get infections more easily when you are taking this medicine. Stay away from people with colds, flu, or other infections. Do not have any vaccines without getting your healthcare provider's approval first. Tell your healthcare provider if you have any signs of infection such as fever, sore throat, or cough.

You may get dehydrated easily while you are receiving this medicine. Drink plenty of water. Tell your healthcare provider if you have any signs of dehydration such as dry mouth, increased thirst, or trouble urinating.

If you need emergency care, surgery, lab tests, or dental work, tell the healthcare provider or dentist you are receiving this medicine.

If you travel, carry some form of identification that says you are taking this medicine. This medicine may set off certain kinds of screening devices.

What are the possible side effects?

Along with its needed effects, your medicine may cause some unwanted side effects. Some side effects may be very serious. Some side effects may go away as your body adjusts to the medicine. Tell your healthcare provider if you have any side effects that continue or get worse.

Life-threatening (Report these to your healthcare provider right away. If you cannot reach your healthcare provider right away, get emergency medical care or call 911 for help.): Allergic reaction (hives, itching, rash, tightness in your chest, swelling of your lips, tongue or throat, trouble breathing).

Serious (Report these to your healthcare provider right away.): Unusual bleeding or bruising; severe weakness or tiredness; swelling in your arms or legs; fever; cough with sputum; shortness of breath; severe nausea, vomiting, or diarrhea; severe abdominal pain; sore throat; mouth sores; blisters; bloody urine; increased thirst; decreased or trouble urinating; pain or burning while urinating; black or bloody bowel movements.

Other: Nausea, vomiting, diarrhea; pain, redness, or swelling at the infusion site.

What products might interact with this medicine?

No significant drug interactions have been reported.

Do not have any vaccines without getting your healthcare provider's approval first.

If you are not sure if your medicines might interact, ask your pharmacist or healthcare provider. Keep a list of all your medicines with you. List all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take. Be sure that you tell all healthcare providers who treat you about all the products you are taking.

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This advisory includes selected information only and may not include all side effects of this medicine or interactions with other medicines. Ask your healthcare provider or pharmacist for more information or if you have any questions.

Ask your pharmacist for the best way to dispose of outdated medicine or medicine you have not used. Do not throw medicines in the trash.

Keep all medicines out of the reach of children.

Do not share medicines with other people.