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 »

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 no longer responds 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 may report side effects to the FDA at 1-800-FDA-1088 1-800-FDA-1088 or www.fda.gov/medwatch.

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