Darolutamide (dar-oh-LOO-ta-mide)

Treats prostate cancer.

Brand Name(s):

Nubeqa

When This Medicine Should Not Be Used:

How to Use This Medicine:

Tablet

• Take your medicine as directed. Your dose may need to be changed several times to find what works best for you.
• It is best to take this medicine with food or milk.
• Swallow the tablet whole. Do not break, crush, or chew it.
• Your doctor may give you other medicines (including a gonadotropin-releasing hormone) unless you had a surgery to lower the amount of testosterone in your body.
• Read and follow the patient instructions that come with this medicine. Talk to your doctor or pharmacist if you have any questions.
• Missed dose: Take a dose as soon as you remember. If it is almost time for your next dose, wait until then and take a regular dose. Do not take extra medicine to make up for a missed dose.
• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep the bottle tightly closed after you first open it.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Some medicines can affect how darolutamide works. Tell your doctor if you are using itraconazole or rosuvastatin.

Warnings While Using This Medicine:

• This medicine may cause birth defects if a man is using it when his partner becomes pregnant. Use an effective form of birth control during treatment with this medicine and for 1 week after the last dose. Tell your doctor right away if a pregnancy occurs while you are using this medicine.
• Tell your doctor if you have kidney disease, liver disease, heart problems, high blood pressure, diabetes, high cholesterol, or a history of brain injury or tumors, seizures, or stroke.
• This medicine may cause the following problems:
  • Heart problem, including ischemic heart disease
  • Seizures
• Talk with your doctor before using this medicine if you plan to have children. Some men who use this medicine have become infertile (unable to have children).
• Your doctor will check your progress and the effects of this medicine at regular visits. Keep all appointments.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Blurred vision, severe headache, slow, fast, or uneven heartbeat, lightheadedness, dizziness
• Chest pain, trouble breathing, nausea or vomiting, sweating, pain in the shoulders, arms, jaw, or neck
• Fever, chills, cough, sore throat, and body aches
• Painful or difficult urination
• Seizures
• Unusual bleeding or bruising

If you notice these less serious side effects, talk with your doctor:

• Constipation, decreased appetite
• Pain in the arms or legs
• Tiredness

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088