Nubeqa is a prescription medicine used to treat prostate cancer.

Nubeqa is used to treat prostate cancer that has not spread to other parts of your body and no longer responds to a medical or surgical treatment that lowers testosterone (non-metastatic castration-resistant prostate cancer or nmCRPC).

Nubeqa is also used to treat prostate cancer that has spread to other parts of the body and responds to medical or surgical treatment that lowers testosterone (metastatic hormone-sensitive prostate cancer or mHSPC), in combination with docetaxel. 

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.

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.

Usual Adult Dose for Prostate Cancer:

600 mg orally 2 times a day

Comments:
- Patients receiving this drug should also receive a gonadotropin-releasing hormone (GnRH) analog concurrently or should have had a bilateral orchiectomy.
- For patients with mHSPC treated with Nubeqa in combination with docetaxel, administer the first cycle of docetaxel within 6 weeks after the start of Nubeqa treatment.

Use: For nonmetastatic castration resistant prostate cancer (nmCRPC), and metastatic hormone-sensitive prostate cancer (mHSPC) in combination with docetaxel.

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.

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.

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

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

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.

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.