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Nubeqa Bayer

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.

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PSA

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

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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.

Graphic outlining nmCRPC, the condition treated by NUBEQA.

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 bone pain and worsen fatigue. It's important to talk to your doctor if you feel new symptoms.

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THE BOTTOM LINE

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

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IMPORTANT SAFETY INFORMATION

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

  • have heart problems, high blood pressure, diabetes, or high amounts of fat or cholesterol in your blood (dyslipidemia)
  • have a history of seizures, brain injury, stroke, or brain tumors
  • have kidney or liver problems
  • are pregnant or plan to become pregnant. NUBEQA can cause harm to your unborn baby and loss of pregnancy (miscarriage)
  • 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
  • are 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 before you talk with the healthcare provider that prescribed NUBEQA.

Know the medicines you take. Keep a list of them with you to show to your healthcare provider and pharmacist when you get a new medicine.

NUBEQA may cause serious side effects, including:

  • Heart disease. Blockage of the arteries in the heart (ischemic heart disease) that can lead to death has happened in some people during treatment with NUBEQA. Your healthcare provider will monitor you for signs and symptoms of heart problems during your treatment with NUBEQA. Call your healthcare provider or get medical help right away if you get chest pain or discomfort at rest or with activity, or shortness of breath during your treatment with NUBEQA
  • Seizure. Treatment with NUBEQA may increase your risk of having a seizure. You should avoid activities where a sudden loss of consciousness could cause serious harm to yourself or others. Tell your healthcare provider right away if you have loss of consciousness or seizure

The most common side effects of NUBEQA in people with nmCRPC include:

  • increase in liver function tests
  • decreased white blood cells (neutropenia)
     
  • feeling more tired than usual
  • arm, leg, hand, or foot pain
  • rash

The most common side effects of NUBEQA when used in combination with docetaxel in people with mHSPC include:

  • constipation
  • decreased appetite
  • rash
  • bleeding
  • weight gain
  • high blood pressure
  • decreased red blood cells (anemia)
  • high blood sugar levels
  • decreased white blood cells
  • increase in liver function tests
  • low blood calcium levels

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 healthcare provider for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Please see the full Prescribing Information.

WHAT IS NUBEQA®?

NUBEQA® (darolutamide) is a prescription medicine used to treat adults with prostate cancer:

  • that has not spread to other parts of the body and no longer responds to medical or surgical treatment that lowers testosterone (non-metastatic castration-resistant prostate cancer or nmCRPC)
  • or
  • that has spread to other parts of the body and responds to medical or surgical treatment that lowers testosterone (metastatic hormone-sensitive prostate cancer or mHSPC), in combination with docetaxel

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

© 2023 Bayer. All rights reserved. BAYER, the Bayer Cross and NUBEQA are registered trademarks of Bayer, and Access Services by Bayer is a trademark of Bayer.

Date of last update: 07/20/2023