Radium-223 dichloride solution for injection

What is this medication?

RADIUM-223 DICHLORIDE (ray dee um) is a radiopharmaceutical drug. This medicine allows radiation to target bone metastases from prostate cancer and prevent fractures and other bone problems caused by cancer bone metastases.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

COMMON BRAND NAME(S): Xofigo

What should I tell my care team before I take this medication?

They need to know if you have any of these conditions:

• blood disorders
• low blood counts
• pregnant or trying to get pregnant
• breast-feeding

How should I use this medication?

This medicine is for injection into a vein. It is given by a health care professional in a hospital or clinic setting.

Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

It is important not to miss your dose. Call your doctor or health care professional if you are unable to keep an appointment.

What may interact with this medication?

Interactions have not been studied.

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medication?

Visit your doctor for checks on your progress. This drug may make you feel generally unwell. This is not uncommon, as chemotherapy can affect healthy cells as well as cancer cells. Report any side effects. Continue your course of treatment even though you feel ill unless your doctor tells you to stop.

Call your doctor or health care professional for advice if you get a fever, chills or sore throat, or other symptoms of a cold or flu. Do not treat yourself. This drug decreases your body's ability to fight infections. Try to avoid being around people who are sick.

This medicine may increase your risk to bruise or bleed. Call your doctor or health care professional if you notice any unusual bleeding.

Be careful brushing and flossing your teeth or using a toothpick because you may get an infection or bleed more easily. If you have any dental work done, tell your dentist you are receiving this medicine.

Avoid taking products that contain aspirin, acetaminophen, ibuprofen, naproxen, or ketoprofen unless instructed by your doctor. These medicines may hide a fever.

Men must use a latex condom during sexual contact with a woman while taking this medicine and for 6 months after you stop taking this medicine. A latex condom is needed even if you have had a vasectomy. Contact your doctor right away if your partner becomes pregnant. Do not donate sperm while taking this medicine and for 6 months after you stop taking this medicine.

This may make it more difficult to father a child. Talk to your healthcare professional if you are concerned about your fertility.

Talk to your doctor about your risk of cancer. You may be more at risk for certain types of cancers if you take this medicine.

Your condition will be monitored carefully while you are receiving this medicine.

You may need blood work done while you are taking this medicine.

What side effects may I notice from receiving this medication?

Side effects that you should report to your doctor or health care professional as soon as possible:

• allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue
• low blood counts - this medicine may decrease the number of white blood cells, red blood cells and platelets. You may be at increased risk for infections and bleeding
• pain, redness, or irritation at site where injected
• signs of infection - fever or chills, cough, sore throat, pain or difficulty passing urine
• signs of decreased platelets or bleeding - bruising, pinpoint red spots on the skin, black, tarry stools, blood in the urine
• signs of decreased red blood cells - unusually weak or tired, feeling faint or lightheaded, falls
• signs of infection - fever or chills, cough, sore throat, pain or trouble passing urine
• swelling of the ankle, feet, hands

Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):

• diarrhea
• dizziness
• dry mouth
• nausea, vomiting

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medication?

This drug is given in a hospital or clinic and will not be stored at home.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.