NOW APPROVED

by the FDA to treat metastatic hormone-sensitive prostate cancer (mHSPC) in combination with chemotherapy (docetaxel)

NUBEQA® (darolutamide) is a prescription medicine used to treat adults with prostate cancer that has spread to other parts of the body and responds to medical or surgical treatment that lowers testosterone; NUBEQA is used in combination with docetaxel.

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

SEE HOW NUBEQA MAY HELP YOU LIVE LIFE LONGER AND GIVE YOU MORE TIME WITHOUT PAIN PROGRESSION

SEE HOW NUBEQA
MAY HELP YOU
LIVE LIFE LONGER AND
GIVE YOU MORE TIME
WITHOUT PAIN PROGRESSION

Explore the clinical results below to see how NUBEQA in addition to chemotherapy* and hormone therapy helped men with mHSPC.

*Docetaxel.

Hormone therapy includes GnRH, such as Lupron Depot® (drug treatment), or surgery that lowers testosterone.

Now you can fight
mHSPC 3 ways at once with
the NUBEQA combination

NUBEQA

Chemotherapy
(docetaxel)

Hormone therapy

NUBEQA is:

  • the first and only treatment of its kind approved for mHSPC in combination with docetaxel
  • a twice-daily, oral prescription medicine that blocks testosterone, which helps delay cancer cell growth

Hormone therapy includes GnRH, such as Lupron Depot® (drug treatment), or surgery that lowers testosterone.

NUBEQA is:

  • the first and only treatment of its kind approved for mHSPC in combination with docetaxel
  • a twice-daily, oral prescription medicine that blocks testosterone, which helps delay cancer cell growth

Hormone therapy includes GnRH, such as Lupron Depot® (drug treatment), or surgery that lowers testosterone.

CLINICALLY PROVEN 
IN MEN WITH mHSPC

In a clinical trial of 1305 men with mHSPC:

  • 651 men received the NUBEQA combination
  • Patients who were given the NUBEQA combination in the clinical trial received chemotherapy* for 6 cycles (approximately 4 months) and continued receiving NUBEQA and hormone therapy until their doctor stopped their treatment
  • 654 men received chemotherapy* + hormone therapy alone
  • Patients received chemotherapy* for 6 cycles (approximately 4 months) and continued receiving hormone therapy until their doctor stopped their treatment
  • Chemotherapy* + hormone therapy is a guideline-recommended therapy in mHSPC
  • The study measured overall survival (OS), which is the length of time a person may live after starting therapy
  • The study also measured:
  • Length of time before disease progressed to mCRPC
  • Length of time before pain progressed

Talk to your doctor to learn more.

*Docetaxel.

Hormone therapy includes GnRH, such as Lupron Depot® (drug treatment), or surgery that lowers testosterone.

In the clinical trial,
MEN LIVED LONGER WITH NUBEQA

At 4 years of treatment in the clinical study:

  • More men who received the NUBEQA combination were still alive (63% compared with 50% of the men who received chemotherapy* + hormone therapy)
  • The NUBEQA combination extended overall survival by lowering the risk of death by 32%

NUBEQA helps you live for what you love

MORE TIME WITHOUT PAIN PROGRESSION

At 4 years of treatment in the clinical study:

  • NUBEQA lowered the risk of time to pain progression by 21%

*Docetaxel.

Hormone therapy includes GnRH, such as Lupron Depot® (drug treatment), or surgery that lowers testosterone.

COMMON SIDE EFFECTS

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

Ask your doctor if NUBEQA is right for you


NUBEQA Patient Brochure

A resource for patients with mHSPC and their caregivers who are considering NUBEQA

NUBEQA Doctor Discussion Guide

A guide to help you prepare questions to ask your doctor about treatment with NUBEQA

Talk to your doctor about the clinical study results published in the

New England Journal of Medicine

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 additional Important Safety Information and 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.