Indication

Xofigo^® (radium Ra 223 dichloride) injection is used to treat prostate cancer that no longer responds to hormonal or surgical treatment that lowers testosterone. It is for men whose prostate cancer has spread to the bone with symptoms but not to other parts of the body.

Important Safety Information

It is not known if Xofigo is safe and effective in women. Xofigo can harm unborn babies when given to a pregnant woman. Men should use condoms and make sure female partners who may become pregnant use birth control (contraception) during treatment and for 6 months after completing treatment with Xofigo.

Before taking Xofigo, tell your healthcare provider if you:

• have bone marrow problems. Xofigo can cause your blood cells counts to go down, including red blood cells, white blood cells, and/or platelets. In a clinical trial, some patients had to permanently discontinue therapy because of bone marrow problems. In addition, there were some deaths and blood transfusions that occurred due to severe bone marrow problems. Your healthcare provider will do blood tests before and during treatment with Xofigo
• are receiving any chemotherapy or another extensive radiation therapy
• are taking Zytiga^® (also known as abiraterone) with prednisone/prednisolone, as this may increase the risk of bone fractures (breaks) and death
• have any other medical conditions

While you are on Xofigo:

• make sure you keep your blood cell count monitoring appointments and tell your healthcare provider about any symptoms or signs of low blood cell counts. Report symptoms or signs of shortness of breath, tiredness, bleeding (such as bruising), or infection (such as fever)
• stay well hydrated and report any signs of dehydration (such as dry mouth and increased thirst), or urinary or kidney problems (such as burning when urinating)
• there are no restrictions regarding personal contact (visual or physical proximity) with other people after receiving Xofigo
• people who are handling fluids such as urine, feces, or vomit of a man taking Xofigo should wear gloves and wash their hands as precaution
• follow good hygiene practices in order to minimize radiation exposure from spills of bodily fluids to household members and caregivers for a period of one week after each injection

The most common side effects of Xofigo include:

• nausea
• diarrhea
• vomiting
• swelling of the arms or legs (peripheral edema)
• low blood cell counts

Tell your healthcare provider if you have any side effects that bother you or do not go away.

For important risk and use information about Xofigo, please see the Full Prescribing Information.

You are encouraged to report side effects or quality complaints of products to the FDA by visiting www.fda.gov/medwatch, or call 1‑800‑FDA‑1088.