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 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) pill bottle

Pill not actual size.

HOW NUBEQA WORKS

Within every prostate cell, there are special molecules called androgen receptors, or AR 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.

Androgen Receptors (AR)

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

Diagram of cells indicating how NUBEQA (darolutamide) works in the body

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

Man Canoeing

NUBEQA HAS CLINICAL PROOF

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, men received either NUBEQA with hormone therapy* or 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 showed that NUBEQA delayed the spread of prostate cancer to other parts of the body. Men who received NUBEQA lived more than twice as long without their cancer spreading compared to men who received hormone therapy alone.

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

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

NUBEQA WAS ALSO STUDIED FOR ITS EFFECT ON OVERALL SURVIVAL

NUBEQA has been shown to significantly extend overall survival (OS), which is how long a person may live after starting therapy.

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

  • Study results about NUBEQA being able to extend OS were not ready at the time the results shown above in the bar chart were done

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

THE BOTTOM LINE

With NUBEQA added to hormone therapy,
IT'S POSSIBLE TO LIVE TWICE AS LONG WITHOUT THE CANCER SPREADING TO OTHER PARTS OF YOUR BODY.

POSSIBLE SIDE EFFECTS WITH NUBEQA

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

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 to 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

COMMON SIDE EFFECTS WITH NUBEQA

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)

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

In a clinical trial, when NUBEQA was added to hormone therapy, it did not cause more men to permanently stop treatment due to side effects. The same percentage of men (9%) permanently stopped taking hormone therapy + NUBEQA as those who took hormone therapy alone.

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

  • 6% of men taking hormone therapy + NUBEQA had to reduce their dosage because of side effects§

Call your doctor for medical advice about side effects. You may report side effects with 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.

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

The most common side effects that caused men to stop taking NUBEQA and then start taking it again were high blood pressure (hypertension; 0.6%), diarrhea (0.5%), and pneumonia (0.5%).

§The most common side effects that caused men to reduce their dosage included fatigue (0.7%), high blood pressure (0.3%), and nausea (0.3%).

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 (darolutamide)

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

  • 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

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

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.