How should I take darolutamide (Nubeqa)?

Darolutamide comes as a tablet to take by mouth. It is usually taken with food twice a day. Take darolutamide at around the same time(s) every day. Take darolutamide exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Swallow the tablets whole; do not split, chew, or crush them. Be sure to talk to your doctor about how you are feeling during your treatment with darolutamide.

Continue to take darolutamide even if you feel well. Do not stop taking darolutamide without talking to your doctor. You can help them by tracking your side effects in Ankr.

What are the side effects of darolutamide (Nubeqa)?

Darolutamide may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration’s (FDA) MedWatch Adverse Event Reporting program online or by phone (1-800-332-1088).

Use the free Ankr platform or Ankr app to track your symptoms.

What special precautions should I follow?

Before taking darolutamide (Nubeqa)

• tell your doctor about your allergies
• tell your doctor about other inatkes.
• tell your doctor if you have or have ever had any disease, symptom, or treatment.
• you should know that darolutamide is only for use in men. Women should not take this medication, especially if they are or may become pregnant or are breastfeeding. If taken by pregnant women, darolutamide may harm the fetus.

While you are on darolutamide (Nubeqa)

• If a pregnant woman takes darolutamide, she should call her doctor immediately. If your female partner is not pregnant but could become pregnant, you and your partner must use birth control during your treatment and for 1 week after your final dose.
• you should know that this medication may decrease fertility in men. However, you should not assume that your female partner cannot become pregnant during your treatment.

I forgot a dose. What should I do?

Take the missed dose as soon as you remember it. Do not take a double dose to make up for a missed one.

In case of an emergency/overdose

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can’t be awakened, immediately call emergency services at 911.

How should I safely store and dispose of darolutamide (Nubeqa)?

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom).

To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

You should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA’s Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

What special dietary instructions should I follow?

Do not eat grapefruit or drink grapefruit juice while taking this medication.

Brand names

• Nubeqa^®

Last Revised – 06/30/2023, FDA upadted-09/15/2019, SG