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.

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

Take with food.

Darolutamide is usually taken 2 times per day. Follow your doctor's dosing instructions very carefully.

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. Keep using your GnRH as directed.

Store tightly closed at room temperature, away from moisture and heat.

Use only as directed. Inform your doctor if you are taking other medicines or have other medical conditions or allergies.

Tell your doctor if you have ever had:

• liver or kidney disease.

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

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

Not for use by women or by anyone younger than 18 years old.

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

Darolutamide may cause serious side effects. Call your doctor right away 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 of darolutamide 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.

Usual Adult Dose for Prostate Cancer:

600 mg orally 2 times a dayComments:-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)

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

Sometimes, it is not safe to use certain medications together. Some drugs can change the levels of other drugs in your blood, 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 other medicines you are using.