WHILE ON XOFIGO

Blood cell count monitoring appointments are very important

Make sure to keep your appointments and be sure to tell your doctor or nurse if you have signs of low blood cell counts, such as:

More bleeding or bruising than usual after an injury
Catching more colds than usual
Fever
Feeling short of breath
Feeling tired

Drink enough fluids

Tell your doctor if you become dehydrated or experience urinary or kidney problems

Bathroom hygiene is important

Your body removes radioactivity mostly through feces. So, while you are being treated with Xofigo—until at least 1 week after the last injection—you should:

Wash your hands well every time you go to the bathroom
Flush the toilet several times after each use
Make sure that if bodily waste is spilled, it is removed completely and quickly. If bodily waste gets on clothing, wash it right away by itself. Afterward, you should wash your hands very well. Anyone who helps you should wash their hands well, too
Wear one-use gloves or gowns any time you clean up bodily waste. Dispose of gloves or gowns as directed by your healthcare provider
Keep your bathroom area clean

Sexual relations during Xofigo therapy

You can have sexual relations while being treated with Xofigo. Because of the possible effect that radiation can have on sperm, you should always use a condom. Also, your female partners should use effective contraception during your treatment and for 6 months after treatment is over.

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.