Darolutamide is used to treat certain types of prostate cancer (cancer that begins in the prostate [a male reproductive gland]) that has not spread to other parts of the body in men who have not been helped by other medical treatments. Darolutamide is also used to treat certain types of prostate cancer (cancer that begins in the prostate [a male reproductive gland]) that have spread to other parts of the body in men in combination with docetaxel. Darolutamide is in a class of medications called androgen receptor inhibitors. It works by blocking the effects of androgen (a male reproductive hormone) to stop the growth and spread of cancer cells.

Darolutamide comes as a tablet to take by mouth. It is usually taken with food twice a day. Take darolutamide at around the same time(s) every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take darolutamide exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Swallow the tablets whole; do not split, chew, or crush them.

Your doctor may tell you to stop taking darolutamide for a short time or decrease your dose if you experience serious side effects during your treatment. Be sure to talk to your doctor about how you are feeling during your treatment with darolutamide.

If your doctor has prescribed another medication such as goserelin (Zoladex), histrelin (Supprelin LA, Vantas), leuprolide (Eligard, Lupron), or triptorelin (Trelstar) to treat your prostate cancer, you will need to continue receiving this medication during your treatment with darolutamide.

Continue to take darolutamide even if you feel well. Do not stop taking darolutamide without talking to your doctor.

Ask your pharmacist or doctor for a copy of the manufacturer’s information for the patient.

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

Before taking darolutamide,

• tell your doctor and pharmacist if you are allergic to darolutamide, any other medications, or any of the ingredients in darolutamide tablets. Ask your pharmacist for a list of the ingredients.
• tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
• tell your doctor what herbal products you are taking, especially St. John’s Wort.
• tell your doctor if you have or have ever had kidney disease, liver disease, heart disease, high blood pressure, diabetes, high blood cholesterol or history of seizures.
• you should know that darolutamide is only for use in men. Women should not take this medication, especially if they are or may become pregnant or are breastfeeding. If taken by pregnant women, darolutamide may harm the fetus. If a pregnant woman takes darolutamide, she should call her doctor immediately. If your female partner is not pregnant but could become pregnant, you and your partner must use birth control during your treatment and for 1 week after your final dose.
• you should know that this medication may decrease fertility in men. However, you should not assume that your female partner cannot become pregnant during your treatment.

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

Take the missed dose as soon as you remember it. Do not take a double dose to make up for a missed one.

Darolutamide may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• extreme tiredness
• arm, leg, hand, or foot pain

Some side effects can be serious. If you experience any of these symptoms, call your doctor immediately:

• arm, leg, hand, or foot pain
• rash
• blood in urine
• fever, rapid and/or shallow breathing, or cough
• chest pain or feeling of pressure in the chest
• seizures

Darolutamide may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration’s (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

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.

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can’t be awakened, immediately call emergency services at 911.

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.

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