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.

Use only as directed. Tell your doctor if you use other medicines or have other medical conditions or allergies.

Follow all directions 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.

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.

Use: For nonmetastatic castration resistant prostate cancer (nmCRPC)

Tell your doctor if you have ever had:

• liver or kidney disease.

May harm an unborn baby or cause a miscarriage. Darolutamide 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.

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.

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.

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom).

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

Do not eat grapefruit or drink grapefruit juice while taking this medication.

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: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Darolutamide may cause serious side effects. 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 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.

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 other medicines you use.

Keep all appointments with your doctor and the laboratory. Your doctor may order certain lab tests to check your body's response to darolutamide.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.