PRESCRIBING INFORMATION

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>®</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.

Date of last update: 04/10/2025

PRESCRIBING INFORMATION

Important Safety Information

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

WHAT IS NUBEQA<sup>®</sup>?