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Nubeqa Bayer

WHEN IT'S TIME TO TAKE ACTION, THERE'S NUBEQA

WHAT IS NUBEQA?

NUBEQA is a pill for prostate cancer that has not spread to other parts of the body and no longer responds to a medical or surgical treatment that lowers testosterone.

NUBEQA (darolutamide) medication pill, bottle, and packaging.

Pill not actual size.

HOW NUBEQA WORKS

Within every prostate cell, there are special molecules called androgen receptors, or ARs for short. When testosterone attaches to an AR, it causes cancer cells to grow. NUBEQA attaches to the AR and blocks testosterone from attaching to it, which helps delay cancer growth.

Illustration of a cell with androgen receptors and testosterone.

Androgen Receptors

Illustration of testosterone attaching to an androgen receptor (AR).

Testosterone attaches to an AR, causing prostate cancer cells to grow

Illustration of NUBEQA blocking testosterone from attaching to androgen receptors (AR).

NUBEQA blocks testosterone from attaching to the AR, helping to delay the cancer cell from growing

Man canoeing in shorts, a denim jacket, a baseball cap, and holding an orange oar.

NUBEQA IS CLINICALLY PROVEN

NUBEQA HAS BEEN PROVEN TO WORK IN THE LARGEST CLINICAL TRIAL OF ITS KIND

NUBEQA was studied in a clinical trial with more than 1500 men with nmCRPC. In this study, 955 men added NUBEQA to their hormone therapy* and 554 men received hormone therapy alone. This study measured the length of time living without the cancer spreading to other parts of the body, also called metastasis-free survival (MFS). The study also measured overall survival (OS), which is how long a person may live after starting therapy.

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

nmCRPC=non-metastatic castration-resistant prostate cancer.

ADDING NUBEQA HELPS KEEP NON-METASTATIC PROSTATE CANCER THAT'S NO LONGER RESPONDING TO HORMONE THERAPY IN ITS PLACE

The study showed that men who added NUBEQA to their hormone therapy lived more than 2X longer without their prostate cancer spreading to other parts of the body than those who did not take NUBEQA.

Graphic that says, ‘NUBEQA patients lived two times longer without cancer spreading vs. hormone therapy alone.’

†Median is the middle value in a set of numbers, not the average.

NUBEQA MAY ALSO HELP YOU LIVE LONGER

The study also showed that NUBEQA significantly extended OS compared with hormone therapy alone.

Graphic shows NUBEQA (darolutamide) clinical trial results - 31% lower risk of death.
Callout of NUBEQA (darolutamide) other clinical trial data

  • NUBEQA extended OS by lowering the risk of death by 31% compared with hormone therapy alone

ADDING NUBEQA TO HORMONE THERAPY OFFERS MEN THESE OTHER BENEFITS

NUBEQA GAVE MEN MORE TIME WITHOUT PAIN

  • In a clinical trial, hormone therapy + NUBEQA relieved pain by nearly 15 months longer
    – 40.3 months compared with 25.4 months (median) for hormone therapy alone

NUBEQA CAN DELAY THE START OF CHEMOTHERAPY

  • In the same clinical trial, more men on hormone therapy + NUBEQA had not started chemotherapy at 3 years compared with men who stayed on hormone therapy alone
    – 83% compared with 75% for hormone     therapy alone

NUBEQA LOWERS PSA LEVELS

In a clinical study

  • NUBEQA lowered PSA levels by an average of more than 90%

PSA=prostate-specific antigen.

Blue and white patterned background.
THE BOTTOM LINE

With NUBEQA added to hormone therapy,
IT'S POSSIBLE TO LIVE 2X LONGER WITHOUT YOUR PROSTATE CANCER SPREADING TO OTHER PARTS OF YOUR BODY.

POSSIBLE SIDE EFFECTS WITH NUBEQA IN PATIENTS WITH nmCRPC

NUBEQA can 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.

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.

Blue coffee cup icon inside a blue circle.

In a clinical study, when NUBEQA was added to hormone therapy* most men (84%) did not report feeling more tired than usual

The most common side effects of hormone therapy + NUBEQA vs hormone therapy alone are

  • Feeling more tired than usual (16% vs 11% on hormone therapy alone)

  • Pain in arm, leg, hand, or foot (6% vs 3% on hormone therapy alone)

  • Rash (3% vs 1% on hormone therapy alone)

  • Decreased white blood cells (neutropenia; 20% vs 9% on hormone therapy alone)

  • Changes in liver function tests (16% vs 7% on hormone therapy alone)

Overall, serious side effects with hormone therapy + NUBEQA were moderately higher than those with hormone therapy alone.

  • Serious side effects happened in 25% of men who added NUBEQA to hormone therapy compared with 20% who took hormone therapy alone

  • Serious side effects that happened in 1% or more of men who added NUBEQA to their hormone therapy included: not being able to urinate completely, pneumonia, and blood in the urine

Sometimes side effects can cause a person to stop treatment when another treatment is added.

In a clinical trial, the tolerability profile of NUBEQA enabled most men to stay on therapy

  • There was no difference in the percentage of men (9%) who permanently stopped treatment due to side effects between those who took hormone therapy + NUBEQA and those who took hormone therapy alone

    Side effects that caused men to permanently stop taking hormone therapy + NUBEQA were heart failure (0.4%) and death (0.4%)

  • That means most men (more than 90%) did not permanently stop taking NUBEQA due to side effects, similar to men who took hormone therapy alone

  • 13% of men had to stop taking NUBEQA and then start it again because of side effects

    The most common reasons were high blood pressure (hypertension; 0.6%), diarrhea (0.5%), and pneumonia (0.5%)

  • 6% of men taking NUBEQA had to reduce their dosage because of side effects

    The most common reasons included fatigue (0.7%), high blood pressure (hypertension; 0.3%), and nausea (0.3%)

Talk to your doctor about the medicines you are taking
Although NUBEQA has a limited potential to interfere with other medicines, it may interfere with some medicines you are taking. So be sure to tell your doctor about all the medicines you are taking, including over-the-counter medicines and supplements.

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

Sometimes side effects can cause a person to stop treatment when another treatment is added.

In a clinical trial, the tolerability profile of NUBEQA enabled most men to stay on therapy

  • There was no difference in the percentage of men (9%) who permanently stopped treatment due to side effects between those who took hormone therapy + NUBEQA and those who took hormone therapy alone
    – Side effects that caused men to permanently stop taking hormone therapy + NUBEQA were heart failure (0.4%) and death (0.4%)

  • That means most men (more than 90%) did not permanently stop taking NUBEQA due to side effects, similar to men who took hormone therapy alone

  • 13% of men had to stop taking NUBEQA and then start it again because of side effects
    – The most common reasons were high blood pressure (hypertension; 0.6%), diarrhea (0.5%), and pneumonia (0.5%)

  • 6% of men taking NUBEQA had to reduce their dosage because of side effects
    – The most common reasons included fatigue (0.7%), high blood pressure (hypertension; 0.3%), and nausea (0.3%)
     

Talk to your doctor about the medicines you are taking
Although NUBEQA has a limited potential to interfere with other medicines, it may interfere with some medicines you are taking. So be sure to tell your doctor about all the medicines you are taking, including over-the-counter medicines and supplements.

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

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088 or by visiting www.FDA.gov/medwatch.

Always tell your doctor about any side effects you may have while taking NUBEQA.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088 or by visiting www.FDA.gov/medwatch.

Always tell your doctor about any side effects you may have while taking NUBEQA.

Blue and white patterned background.
THE BOTTOM LINE

DISCUSS SIDE EFFECTS with your treatment
team.

HOW TO TAKE NUBEQA

TAKE NUBEQA EXACTLY AS YOUR DOCTOR TELLS YOU

TAKE YOUR PRESCRIBED DOSE OF NUBEQA 2 TIMES A DAY WITH FOOD

NUBEQA (darolutamide) dosing infographic: Take prescribed doses two times daily with food.

NUBEQA Dosing: The recommended dose of NUBEQA is 600 mg (two 300 mg tablets) taken by mouth, twice daily.

  • Swallow NUBEQA tablets whole

    • If you miss a dose of NUBEQA, take your normal dose as soon as possible prior to the next scheduled dose

      • Return to your normal schedule on the following day. Do not take 2 doses together to make up for a missed dose

FOLLOW YOUR DOCTOR'S INSTRUCTIONS WHILE TAKING NUBEQA

  • Your doctor may change your dose if needed. Do not stop taking your prescribed dose of NUBEQA without talking with your doctor first

  • You should continue hormone therapy* during your treatment with NUBEQA unless you had surgery to lower the amount of testosterone in your body (surgical castration)

  • If you take more NUBEQA than prescribed, call your healthcare provider right away

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

More information Less information
More information Less information
More information Less information

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