Xofigo® - radium Ra 223 dichloride injection

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. Continue reading below

Before Treatment With Xofigo®

Xofigo is not for use in women. It should not be given to women who are pregnant or who may become pregnant. Taking Xofigo could potentially harm their unborn baby. Women who are pregnant or who may become pregnant should not come in contact with Xofigo without protection, such as wearing gloves.

If you suffer from bone marrow problems (a decrease in blood cell production in the bone marrow), your healthcare provider will decide if treatment is appropriate. 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.

Xofigo can cause your blood cells counts to go down. Your healthcare provider will do blood tests before and during treatment with Xofigo.

Tell your healthcare provider if you are receiving any chemotherapy or any extensive radiation therapy. The use of chemotherapy while taking Xofigo is not recommended.

Tell your healthcare provider if you have any other medical conditions.

During and After Treatment With 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.

Bathroom hygiene is important. Radioactivity is present in urine and feces after treatment. Be sure to practice good personal hygiene while receiving Xofigo and for at least 1 week after the last injection.

After going to the bathroom, be sure to wash your hands thoroughly and flush the toilet several times. Promptly clean up spilled bodily waste, wearing gloves when you clean. Dispose of gloves as directed by the healthcare provider who gave you your Xofigo treatment. Wash your hands when you are finished. If bodily waste gets into clothing, promptly wash it separately.

Use condoms and make sure female partners who can have children use highly effective birth control methods during and for a minimum of 6 months after treatment with Xofigo.

The most common side effects of Xofigo include nausea, diarrhea, vomiting, swelling of the arms or legs (peripheral edema), and low blood cell counts. Tell your healthcare provider if you have any side effects that bother you or do not go away.

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:

While you are on Xofigo:

The most common side effects of Xofigo include:

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

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