Jul 27, 2022

Generic name:  darolutamide  [ DAR-oh-LOO-ta-mide ]
Drug classes:  Antiandrogens ,  Hormones / antineoplastics

What is Nubeqa?

Nubeqa a prescription medicine used to treat  prostate cancer  that has not spread to other parts of your body.

Nubeqa is given after surgery or other treatments did not work or have stopped working.

It is not known if Nubeqa is safe and effective in children or in females.


Follow all directions on your medicine label and package. Tell each of your healthcare providers about all your medical conditions,  allergies , and all medicines you use.

Before taking this medicine

To make sure Nubeqa is safe for you, tell your doctor if you have ever had:

  • liver or kidney disease.

Darolutamide may harm an unborn baby or cause a miscarriage. Nubeqa is not for use by women. Use effective  birth control  if your sex partner is able to get pregnant. Keep using birth control for at least 1 week after your last dose. Tell your doctor right away if a pregnancy occurs while you are using Nubeqa.

It may be harder for you to get a woman pregnant while you are using Nubeqa. You should still use birth control to prevent pregnancy because the medicine can harm an unborn baby.

Nubeqa is not for use by women or by anyone younger than 18 years old.

How should I take Nubeqa?

Take Nubeqa exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets.

Take with food.

Swallow the tablet whole and do not crush, chew, or break it.

If you have not had castration surgery (to lower the amount of testosterone in your body), your doctor may also prescribe a gonadotropin-releasing hormone (GnRH) medicine such as  Eligard ,  Lupron , Trelstar,  Zoladex , or Vantas. Keep using your GnRH as directed.

Store at room temperature away from moisture and heat. Keep the bottle tightly closed when not in use.

Dosing information

Usual Adult Dose for Prostate Cancer:

600 mg orally 2 times a day

-Patients receiving this drug should also receive a gonadotropin-releasing hormone (GnRH) analog concurrently or should have had a bilateral orchiectomy.

Use: For nonmetastatic castration resistant prostate cancer (nmCRPC)

Detailed Nubeqa dosage information

What happens if I miss a dose?

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What to avoid

Follow your doctor’s instructions about any restrictions on food, beverages, or activity.

Nubeqa side effects

Get emergency medical help if you have signs of an allergic reaction to Nubeqa:  hives ; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

  • severe ongoing  nausea  or  diarrhea ;
  • painful or difficult urination;
  • blood in your urine;
  • severe  headache , blurred vision, pounding in your neck or ears;
  • slow heart rate , weak pulse, fainting, slow breathing (breathing may stop);
  • signs of a blood clot in the lung – chest pain, sudden cough, wheezing, rapid breathing,  coughing up blood ; or
  • signs of a lung infection – fever, chills, cough with mucus, chest pain, shortness of breath.

Your cancer treatments may be delayed if you have certain side effects.

Common Nubeqa side effects may include:

  • feeling tired;
  • pain in your arms, hands, legs, or feet;
  • rash;
  • low white blood cells; or
  • abnormal  liver function tests .

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Nubeqa side effects  (more detail)

What other drugs will affect Nubeqa?

Sometimes it is not safe to use certain medications at the same time. Some drugs can affect your blood levels of other drugs you take, which may increase side effects or make the medications less effective.

Other drugs may intweact with darolutamide, including prescription and over-the-counter medicines,  vitamins , and  herbal products . Tell your doctor about all your current medicines and any medicine you start or stop using.

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