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SIDE EFFECTS

NUBEQA may cause serious side effects, including:

Heart icon

Heart disease. Blockage of the arteries in the heart (ischemic heart disease) that can lead to death has happened in some people during treatment with NUBEQA. Your healthcare provider will monitor you for signs and symptoms of heart problems during your treatment with NUBEQA. Call your healthcare provider or get medical help right away if you get chest pain or discomfort at rest or with activity, or shortness of breath during your treatment with NUBEQA

Icon of human brain

Seizure. Treatment with NUBEQA may increase your risk of having a seizure. You should avoid activities where a sudden loss of consciousness could cause serious harm to yourself or others. Tell your healthcare provider right away if you have loss of consciousness or seizure

Most common side effects of NUBEQA

Select a type of prostate cancer to see side effects.

    Metastatic hormone-sensitive prostate cancer mHSPC

    Most common side effects of NUBEQA in adults with mHSPC when combined with docetaxel (chemotherapy):

    Icon of intestine with text of constipation

    Constipation

    Icon on rashes on hand

    Rash

    Icon of fork and knife with text of decreased appetite

    Decreased
    appetite

    Blood droplets with text of bleeding

    Bleeding

    Icon of weight machine with a plus symbol with text of weight gain

    Weight gain

    Icon of heart and pulse with text of high blood pressure

    High blood
    pressure

    Icon of platelets with down arrow and text of decreased red blood cells (anemia)

    Decreased red blood cells (anemia)

    Increasing blood sugar level

    High blood sugar levels

    Icon of wheel with down arrow and text of decreased white blood cells (neutropenia)

    Decreased white blood cells (neutropenia)

    Icon of liver with up arrow with text of increase in liver function tests

    Increase in liver function tests

    Icon of blood drop with a down arrow with text of low blood calcium levels

    Low blood calcium levels

    NUBEQA may cause fertility problems in males, which may affect their ability to father children. Talk to your healthcare provider if you have concerns about fertility.

    These are not all the possible side effects of NUBEQA.

    Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

    Non-metastatic castration-resistant prostate cancer nmCRPC

    Most common side effects of NUBEQA in adults with nmCRPC:

    Blue icon of liver with up arrow with text of increase in liver function tests

    Increase in liver function tests

    Blue icon of wheel with down arrow and text of decreased white blood cells (neutropenia)

    Decreased white blood cells (neutropenia)

    Icon of a tired man with a low battery resting head on his hand

    Feeling more
    tired than usual

    Blue icon of liver with up arrow with text of increase in liver function tests

    Increase in liver function tests

    Blue icon of wheel with down arrow and text of decreased white blood cells (neutropenia)

    Decreased white blood cells (neutropenia)

    Icon of a shoulder with text of arm, leg, hand or foot pain

    Arm, leg, hand, or foot pain

    Blue icon of rashes on hand

    Rash

    Icon of a tired man with a low battery resting head on his hand

    Feeling more
    tired than usual

    Icon of a shoulder with text of arm, leg, hand or foot pain

    Arm, leg, hand, or foot pain

    Blue icon of rashes on hand

    Rash

    NUBEQA may cause fertility problems in males, which may affect their ability to father children. Talk to your healthcare provider if you have concerns about fertility.

    These are not all the possible side effects of NUBEQA.

    Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

    About NUBEQA
    Taking NUBEQA

    Important Safety Information

    Before taking NUBEQA, tell your healthcare provider about all your medical conditions, including if you:

    • have heart problems, high blood pressure, diabetes, or high amounts of fat or cholesterol in your blood (dyslipidemia)
    • have a history of seizures, brain injury, stroke, or brain tumors
    • have kidney or liver problems
    • are pregnant or plan to become pregnant. NUBEQA can cause harm to your unborn baby and loss of pregnancy (miscarriage)
    • have a partner who may become pregnant. Males who have female partners who may become pregnant should use effective birth control (contraception) during treatment and for 1 week after the last dose of NUBEQA. Talk with your healthcare provider about birth control methods
    • are breastfeeding or plan to breastfeed. It is not known if NUBEQA passes into breast milk

    Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. NUBEQA may affect the way other medicines work and other medicines may affect how NUBEQA works.

    You should not start or stop any medicine before you talk with the healthcare provider that prescribed NUBEQA.

    Know the medicines you take. Keep a list of them with you to show to your healthcare provider and pharmacist when you get a new medicine.

    NUBEQA may cause serious side effects, including:

    • Heart disease. Blockage of the arteries in the heart (ischemic heart disease) that can lead to death has happened in some people during treatment with NUBEQA. Your healthcare provider will monitor you for signs and symptoms of heart problems during your treatment with NUBEQA. Call your healthcare provider or get medical help right away if you get chest pain or discomfort at rest or with activity, or shortness of breath during your treatment with NUBEQA
    • Seizure. Treatment with NUBEQA may increase your risk of having a seizure. You should avoid activities where a sudden loss of consciousness could cause serious harm to yourself or others. Tell your healthcare provider right away if you have loss of consciousness or seizure

    The most common side effects of NUBEQA in people with nmCRPC include:

    • increase in liver function tests
    • decreased white blood cells (neutropenia)
    • feeling more tired than usual
    • arm, leg, hand, or foot pain
    • rash

    The most common side effects of NUBEQA when used in combination with docetaxel in people with mHSPC include:

    • constipation
    • rash
    • decreased appetite
    • bleeding
    • weight gain
    • high blood pressure
    • decreased red blood cells (anemia)
    • high blood sugar levels
    • decreased white blood cells
    • increase in liver function tests
    • low blood calcium levels

    NUBEQA may cause fertility problems in males, which may affect the ability to father children. Talk to your healthcare provider if you have concerns about fertility.

    These are not all the possible side effects of NUBEQA.

    Call your healthcare provider for medical advice about side effects. You are encouraged to report side effects or quality complaints of products to the FDA by visiting www.fda.gov/medwatch or calling 1-800-FDA-1088.

    Please see the full Prescribing Information.

    WHAT IS NUBEQA<sup>&reg;</sup>?

    NUBEQA® (darolutamide) is a prescription medicine used to treat adults with prostate cancer:

    • that has not spread to other parts of the body and no longer responds to medical or surgical treatment that lowers testosterone (non-metastatic castration-resistant prostate cancer or nmCRPC),
    • or
    • that has spread to other parts of the body and responds to medical or surgical treatment that lowers testosterone (metastatic hormone-sensitive prostate cancer or mHSPC), in combination with docetaxel

    It is not known if NUBEQA is safe and effective in women or children.

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    Date of last update: 09/12/2024