darolutamide

darolutamide

[en Español]

darolutamide

Pronunciation: DAR oh LOO ta mide

Brand: Nubeqa

What is the most important information I should know about darolutamide?

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.

What is darolutamide?

Darolutamide is used to treat prostate cancer that has not spread to other parts of your body.

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

Darolutamide may also be used for purposes not listed in this medication guide.

What should I discuss with my healthcare provider before taking darolutamide?

Tell your doctor if you have ever had:

  • liver or kidney disease.

Although darolutamide is not for use by women, this medicine can harm an unborn baby or cause a miscarriage if a woman is exposed to it during pregnancy.

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 darolutamide.

This medicine may affect fertility (your ability to have children). However, it is important to use birth control to prevent pregnancy because darolutamide can harm an unborn baby.

How should I take darolutamide?

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

Take with food.

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

If you have not had 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.

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 should I avoid while taking darolutamide?

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

What are the possible side effects of darolutamide?

Get emergency medical help if you have signs of an allergic reaction: 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 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.

What other drugs will affect darolutamide?

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 affect 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.

Where can I get more information?

Your pharmacist can provide more information about darolutamide.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

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