THIS SITE IS FOR US AUDIENCES ONLY.

Important Safety Information

Xofigo® is not indicated for women. Women who are pregnant or may become pregnant should not receive Xofigo and should practice safe sex, such as having their partner wear a condom and using effective birth control, as Xofigo can harm unborn babies. Continue reading below.

THIS SITE IS FOR US AUDIENCES ONLY.

Important Safety Information

Xofigo® is not indicated for women. Women who are pregnant or may become pregnant should not receive Xofigo and should practice safe sex, such as having their partner wear a condom and using effective birth control, as Xofigo can harm unborn babies. Continue reading below.


What is Advanced Prostate Cancer?

Everyone’s prostate cancer story is different—but treatment goals remain the same

There are thousands of men, just like you, who are fighting prostate cancer that has spread to the bones. One of the reasons it may have spread is because your cancer is no longer responding to therapies aimed at lowering testosterone. The medical term for this condition is metastatic castration-resistant prostate cancer (mCRPC).

When prostate cancer spreads to your bones, a treatment change may be necessary.

For 9 Out of 10 Men with mCRPC, Prostate Cancer Spreads to the Bones For 9 Out of 10 Men with mCRPC, Prostate Cancer Spreads to the Bones, Xofigo

It is important to know that even if the cancer has spread to your bones and you may no longer have a prostate, it is still considered prostate cancer, not bone cancer.

Your doctor may also refer to advanced prostate cancer as “metastatic” or “late-stage” disease. It may also be referred to as “mCRPC.”

How you and your doctor can monitor your disease

If your doctor suspects prostate cancer has spread to your bones, tests such as a
bone scan, checking ALP levels, or a PSA test should be considered. ALP is a substance that may be released into the bloodstream when bones break down. High levels of ALP give your doctor a better idea if your disease has spread to bone.

PSA tests screen for prostate cancer but are also an important tool for men with the disease to determine how their cancer is reacting to treatment. Changes in your PSA levels may be a sign that your disease is advancing. In advanced prostate cancer, PSA tests alone should not be used to determine long-term outcomes, like living longer.

Be open and honest with your doctors. This will help them figure out if a treatment change or an additional therapy is the right approach for you.

Indication

Xofigo 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

Xofigo is not indicated for women. Women who are pregnant or may become pregnant should not receive Xofigo and should practice safe sex, such as having their partner wear a condom and using effective birth control, as Xofigo can harm unborn babies. 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.

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 side effects or quality complaints of products to the FDA by visiting www.fda.gov/medwatch, or call 1‑800‑FDA‑1088. For Bayer products, you can report these directly to Bayer by clicking here.