Generic name: darolutamide (DAR oh LOO ta mide)
Brand name: Nubeqa
Drug class: Antiandrogens, Hormones / antineoplastics
Nubeqa (darolutamide) 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.
Although Nubeqa 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 Nubeqa.
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 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 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
-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)
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;
- 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 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.