What is Nubeqa® (darolutamide)?

Reviewed by: HU Medical Review Board | Last reviewed: August 2022 | Last updated: August 2022

Darolutamide (Nubeqa®) is an androgen receptor inhibitor used to block the signal of the androgen receptor for those with prostate cancer. The drug is used to treat prostate cancer that has not spread to other parts of the body and no longer responds to testosterone-lowering treatments. This type of cancer is called non-metastatic castration-resistant prostate cancer (nmCRPC).1,2

Darolutamide also can be used in combination with the drug docetaxel to treat metastatic hormone-sensitive prostate cancer (mHSPC).3

What are the ingredients in darolutamide?

The active ingredient is darolutamide.2

How does darolutamide work?

The hormones in your body carry messages through your bloodstream to your tissues or organs. They affect many complex processes within your body, including:4

  • Mood
  • Sexual function
  • Reproduction
  • Growth and development
  • Energy use from food

Testosterone is a hormone that belongs to a family of hormones called androgens. Testosterone plays a major role in male development and health. The development and growth of prostate cancer are complex, and the exact process is still not entirely known. However, abnormal signaling of the androgen receptor may be a factor in the development of prostate cancer.5,6

Some men have a type of prostate cancer that needs to be treated by lowering testosterone levels. If the cancer comes back after treatment, the androgen hormone in your body may be low but the signaling of the receptor in your body may still be abnormal. When this happens, your doctor may prescribe an androgen receptor inhibitor drug to treat the nmCRPC.5,6

Because it is an androgen receptor inhibitor drug, darolutamide may be effective in treating nmCRPC.1,2

What are the possible side effects of darolutamide?

The most common side effects of darolutamide include:2

  • Feeling more tired than normal
  • Arm, leg, hand, or foot pain
  • Rash
  • Decreased blood cells that help fight infection
  • Changes in liver function

These are not all the possible side effects of darolutamide. Talk to your doctor about what to expect when taking darolutamide. You also should call your doctor if you have any changes that concern you when taking darolutamide.

Other things to know

If you have severe kidney or liver disease, darolutamide may build up in your body at an unsafe level. Talk to your doctor about your medical history to make sure the correct dose is given to you.2

There is not enough information about darolutamide to know if it is safe for people who are pregnant or could become pregnant. Darolutamide may be harmful to a developing baby and can cause loss of pregnancy. Use effective birth control if your partner is of childbearing age. Darolutamide also may interfere with men's ability to reproduce.2

Before beginning treatment for prostate cancer, tell your doctor about all your health conditions and any other drugs, vitamins, or supplements you are taking. This includes over-the-counter drugs.

For more information, read the full prescribing information of darolutamide.

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