IMPORTANT SAFETY INFORMATION

NUBEQA can harm unborn babies and cause loss of pregnancy. Men with female partners who may become pregnant should use effective birth control Continue reading »

IMPORTANT SAFETY INFORMATION

NUBEQA can harm unborn babies and cause loss of pregnancy. Men with female partners who may become pregnant should use effective birth control (contraception) Continue reading »

WHEN YOU NEED MORE THAN YOUR CURRENT HORMONE THERAPY*

When you have prostate cancer, the testosterone in your body causes it to grow and spread. You may already be on a hormone therapy, such as Lupron Depot®, to bring your testosterone down to very low levels, but it may not be enough to keep the cancer from starting to grow again. When that happens, you may need to add another medication to the one you are already taking.

Explanation of what rising levels mean during therapy

PSA

When hormone therapy works, your prostate-specific antigen (PSA) level drops and stays low.

Explanation of what rising levels mean during therapy

PSA

But when your hormone therapy stops working, your PSA levels rise, even if your cancer has not spread. That means you have nmCRPC.

*Hormone therapy includes drug treatments or surgery that lowers testosterone.

Lupron Depot® is a registered trademark of AbbVie Inc.

WHAT IS NON-METASTATIC CASTRATION-RESISTANT PROSTATE CANCER (nmCRPC)?

The graphic below will help you to understand what nmCRPC means by explaining each part of the term separately.

Explanation of the condition

RISING PSA LEVELS MEAN THAT YOUR CANCER COULD SPREAD

  • It is very important that your doctor monitors your PSA levels. Your PSA levels may rise even if you are on hormone therapy*

  • If your PSA levels rise, it means that your cancer is castration-resistant (CR). That means that the prostate cancer keeps growing even when the amount of testosterone in the body is reduced to very low levels

*Hormone therapy includes drug treatments or surgery that lowers testosterone.

WHY DOES DELAYING THE SPREAD OF CANCER MATTER?

When prostate cancer spreads to other parts of the body, it can cause symptoms like feeling tired and even bone pain. It's important to talk to your doctor if you feel new symptoms.

THE BOTTOM LINE

TAKE ACTION to delay the spread of cancer to other parts of your body.

INDICATION

NUBEQA® (darolutamide) is a prescription medicine used to treat men with prostate cancer that has not spread to other parts of the body and is no longer responding to a medical or surgical treatment that lowers testosterone.

It is not known if NUBEQA is safe and effective in women and children.

IMPORTANT SAFETY INFORMATION

NUBEQA can harm unborn babies and cause loss of pregnancy. Men with female partners who may become pregnant should use effective birth control (contraception) during treatment and for 1 week after the last dose of NUBEQA.

Before taking NUBEQA, tell your healthcare provider about all your medical conditions, including if you:

  • Have kidney or liver problems
  • Have a partner who may become pregnant. Males who have female partners who may become pregnant should use effective birth control (contraception) during treatment and for 1 week after the last dose of NUBEQA. Talk with your healthcare provider about birth control methods
  • For women, tell your healthcare provider if you are:
    • pregnant or plan to become pregnant. NUBEQA can cause harm to your unborn baby and loss of pregnancy (miscarriage)
    • breastfeeding or plan to breastfeed. It is not known if NUBEQA passes into breast milk

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. NUBEQA may affect the way other medicines work and other medicines may affect how NUBEQA works.

You should not start or stop any medicine without talking to your healthcare provider.

Most common side effects of NUBEQA include:

  • Feeling more tired than usual
  • Arm, leg, hand, or foot pain
  • Rash
  • Decreased white blood cells (neutropenia)
  • Changes in tests that determine how your liver works (liver function tests)

NUBEQA may cause fertility problems in males, which may affect the ability to father children. Talk to your healthcare provider if you have concerns about fertility.

These are not all the possible side effects of NUBEQA. Call your doctor for medical advice about side effects. You are encouraged to report side effects or quality complaints of products to the FDA by visiting www.fda.gov/medwatch or calling 1-800-FDA-1088.

For important risk and use information about NUBEQA, please see the full Prescribing Information.