THIS SITE IS FOR US AUDIENCES ONLY.

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... Continue reading below.

THIS SITE IS FOR US AUDIENCES ONLY.

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.


Terms To Know

ADT (androgen-deprivation therapy)
ADT works to lower levels of male hormones that help prostate cancer grow. ADT is used to treat prostate cancer that has returned after surgery and radiation therapy, or cancer that has spread to other parts of the body.

Advanced prostate cancer
Cancer that has spread outside the prostate to other parts of the body.

ALP (alkaline phosphatase)
A substance that may be released into the bloodstream when bones break down.

Androgens
Male sex hormones like testosterone.

Bisphosphonates
Bisphosphonates treat cancer that has spread to the bone. They are used to protect the bone from the damaging effects of cancer.

Bone metastases
Cancer that has spread to your bones, but initially started in a different part of the body.

Bone scan
This test of the entire skeleton can show if prostate cancer has spread to the bones.

Chemotherapy
Chemotherapy may be used when prostate cancer has spread outside of the prostate gland and hormone therapy isn’t working. Its goal is to destroy cancer cells by stopping them from growing or dividing into more cancer cells.

Hormonal therapy
This type of therapy can block an enzyme that stops the testicles from making testosterone. It can also interfere with androgen receptors that receive and transmit signals, which may reduce tumor growth.

Immunotherapy
Immunotherapy uses a person’s own immune system to fight and kill cancer cells.

mCRPC (metastatic castration-resistant prostate cancer)
The medical term for when prostate cancer has spread to bone and the cancer is no longer responding to therapies aimed at lowering testosterone.

Placebo
A substance such as a sugar pill or an injection of water, given under the belief that it is an effective treatment.

PSA (prostate-specific antigen)
A substance that is released into the bloodstream and is usually at high levels in men with prostate cancer.

PSA (prostate-specific antigen) test
A test that screens for prostate cancer, but is also an important tool for men with the disease to determine how their cancer is reacting to treatment.

Radioactive material
A substance that gives off radiation as it decays.

Radiopharmaceuticals (alpha-emitting)
Alpha-emitting radiopharmaceuticals treat cancer that has spread to the bone. They are injected into a vein (intravenously, or IV) and travel throughout the body to settle predominantly in areas of bone affected by cancer.

Radiopharmaceuticals (beta-emitting)
Beta-emitting radiopharmaceuticals are used to treat bone pain due to cancer that spread to the bone. They are injected into a vein (intravenously, or IV).

Radiation therapy including EBRT to treat pain
Radiation kills cancer cells by destroying the part responsible for controlling how cells grow and divide. External beam radiation therapy (EBRT), a type of radiation, provides relief from the painful symptoms of bone metastases.

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.