Indication

Xofigo (radium Ra 223 dichloride) injection is used to treat prostate cancer that is resistant to medical or surgical treatments that lower testosterone and has spread to your bones with symptoms, but not to other parts of your body. The medical term for this condition is metastatic castration-resistant prostate cancer, or mCRPC.

Important Safety Information

Do not take Xofigo if you are pregnant or may become pregnant. Xofigo can harm your unborn baby. Women who are pregnant or who may become pregnant should not come in contact with Xofigo without protection, such as gloves.

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
• 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 contact with other people after receiving Xofigo
• 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
• use condoms and make sure female partners who may become pregnant use highly effective birth control methods during and for a minimum of six months after treatment with Xofigo

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 negative side effects or quality complaints of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1‑800‑FDA‑1088.