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Nubeqa

darolutamide
Used for Prostate Cancer
Used for Prostate Cancer

Nubeqa (darolutamide) is an antiandrogen. It’s a hormone therapy used to treat certain types of prostate cancer. Nubeqa (darolutamide) is typically prescribed along with chemotherapy or with another hormonal medication that targets gonadotropin-releasing hormone (GnRH). Nubeqa (darolutamide) is taken by mouth twice daily. Some of the more common side effects of this medication include tiredness, constipation, and poor appetite.

Last reviewed on March 25, 2024
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What is Nubeqa (darolutamide)?

What is Nubeqa (darolutamide) used for?

How Nubeqa (darolutamide) works

Most prostate cancer cells need testosterone to grow and spread. Testosterone is a type of male sex hormone called an androgen.

Nubeqa (darolutamide) is an androgen receptor inhibitor (antiandrogen). It's a type of hormone therapy that works by blocking testosterone from binding to prostate cancer cells. Without testosterone, cancer cells won’t have the fuel they need to grow or spread as well.

Are you looking for information on Erleada (apalutamide) or Xtandi (enzalutamide) instead?

Drug Facts

Common BrandsNubeqa
Drug ClassAnti-androgen
Controlled Substance ClassificationNot a controlled medication
Generic StatusNo lower-cost generic available
AvailabilityPrescription only
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What are the side effects of Nubeqa (darolutamide)?

The following side effects may get better over time as your body gets used to the medication. Let your healthcare provider know immediately if you continue to experience these symptoms or if they worsen over time.

Common Side Effects

Prostate cancer that hasn't yet spread:Prostate cancer that has already spread:
  • Lower red blood cell count (72%)
  • Higher blood sugar levels (57%)
  • Lower white blood cell count (up to 52%)
  • Changes in liver labs (up to 40%)
  • Lower blood calcium level (31%)
  • Constipation (23%)
  • Not eating as much or not feeling hungry (19%)
  • Rash (19%)
  • Bleeding that's difficult to stop (18%)
  • Weight gain (18%)
  • Headaches, dizziness, and other symptoms of high blood pressure
Note: Studies included people who took Nubeqa with one or more anticancer medications.

Other Side Effects

Prostate cancer that hasn't yet spread:
  • Rash
  • Pain in arms or legs
Prostate cancer that has already spread:
  • Muscle pain
  • Lung infection (pneumonia)

Serious Side Effects

Contact your healthcare provider immediately if you experience any of the following.
  • Seizures
  • Heart problems: chest pain, racing heartbeat, shortness of breath, arm or shoulder pain, swelling of your legs or feet, sudden weight gain, sweating, fatigue, dizziness, nausea or vomiting
  • Serious bleeds: bleeding or bruising that doesn’t stop or go away, large amount of bleeding, blood in the urine, throwing up blood, bloody or black and tarry stool
  • Severe skin reactions: painful blisters, skin wounds, peeling skin

Source: DailyMed

The following side effects have also been reported

Side effects that you should report to your care team as soon as possible:

Side effects that usually do not require medical attention (report these to your care team if they continue or are bothersome):

pros-and-cons

Pros and cons of Nubeqa (darolutamide)

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Pros

Recommended option for certain types of prostate cancer

Can treat prostate cancer that is no longer responding to other hormonal therapies

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Cons

Taken twice a day

Must be taken with food

Might need to be taken with docetaxel (Taxotere), which is an IV infusion

No generic medication available

pharmacist-tips

Pharmacist tips for Nubeqa (darolutamide)

pharmacist
  • Take Nubeqa (darolutamide) with food. This helps your body better absorb the medication. Swallow tablets whole. Don’t cut, crush, or chew the tablets.

    • If you miss a dose of Nubeqa (darolutamide) and it’s not time for your next dose, take your missed dose as soon as possible. If it’s time for your next dose, skip the missed dose, and take your next dose at your next regularly scheduled time. Don't take two doses at the same time.

      • Your oncologist might ask you to take Nubeqa (darolutamide) along with a medication that lowers testosterone levels, such as Lupron Depot (leuprolide) or Firmagon (degarelix), unless you’ve had surgery to remove both testicles. If you're not, double check with your oncologist about your treatment plan.

        • Certain medications, such as clarithromycin (Biaxin) or diltiazem (Cardizem), can interact with Nubeqa (darolutamide), which can change the levels of Nubeqa (darolutamide) in your body. This can affect how well Nubeqa (darolutamide) works to treat prostate cancer or raise your risk of side effects. Before starting any new medications, ask your care team to help you check for medication interactions.

          • If your partner is able to become pregnant, use appropriate birth control measures, such as condoms or birth control pills, while you’re taking Nubeqa (darolutamide), and for 1 week after your last dose. It’s possible for Nubeqa (darolutamide) to cause birth defects or pregnancy loss in female partners of males who are taking this medication. Talk with your oncologist if you have questions about birth control options for you and your partner.

            • Ask your oncologist or pharmacist about the best way to handle and dispose of Nubeqa (darolutamide). Cancer medications can be very harmful to people who handle or come into contact with them, so you need to get rid of them safely.

              faqs

              Frequently asked questions about Nubeqa (darolutamide)

              Is Nubeqa (darolutamide) a chemotherapy?
              Nubeqa (darolutamide) isn't a chemotherapy medication. Chemotherapy is a class of medication that targets and kills cancer cells in your body. Nubeqa (darolutamide) doesn’t kill cancer cells. Instead, it’s a form of hormonal therapy called an androgen receptor inhibitor, or antiandrogen. It works by blocking the male sex hormone, testosterone, in your body. Most prostate cancer cells need testosterone to grow and spread. By blocking testosterone, Nubeqa (darolutamide) blocks the “fuel” cancer cells need to grow or spread.
              Who makes Nubeqa (darolutamide)?
              Nubeqa (darolutamide) is a brand-name medication made by Bayer Pharmaceuticals.
              How long do you take Nubeqa (darolutamide) for?
              How long you take Nubeqa (darolutamide) depends on several factors, such as how well the medication is working to treat your cancer and how well you're tolerating the side effects. Your oncologist will monitor how well Nubeqa (darolutamide) is working for you by checking your prostate-specific antigen (PSA) levels through blood tests or looking scan results. They’ll also check in with you regularly to see if symptoms of prostate cancer, such as trouble urinating or blood in the urine, are improving. Let your oncologist know if you experience Nubeqa (darolutamide) side effects, such as tiredness or constipation. If so, they might need to pause or lower your dose. Ask your oncologist if you have more questions about Nubeqa (darolutamide) treatment.
              Why do I need to take Nubeqa (darolutamide) with food?
              It’s important that you take Nubeqa (darolutamide) with food because food affects how much Nubeqa (darolutamide) gets absorbed in your body. If you don’t take it with food, your body might not absorb enough medication. This means that Nubeqa (darolutamide) might not work as well to treat your cancer.
              How does Nubeqa (darolutamide) compare to other antiandrogens in treating prostate cancer?
              Nubeqa (darolutamide) and other newer antiandrogens might work better at treating castration-resistant prostate cancer compared with the older antiandrogens, such as flutamide (Eulexin) and bicalutamide (Casodex). This is because the newer antiandrogens are able to block testosterone better than the older ones. Your oncologist will work with you to determine which prostate cancer medication is the best option for you. The different options typically have different dosing and slightly different side effects. Your oncologist will help you choose one depending on many factors, including the type and stage of your prostate cancer, how well your body handles the side effects, other medical conditions you might have, and cost. Talk with your oncologist if you have any questions about the benefits and risks for any of the treatment options.
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              What are the risks and warnings for Nubeqa (darolutamide)?

              Nubeqa (darolutamide) can cause some serious health issues. This risk may be even higher for certain groups. If this worries you, talk to your doctor or pharmacist about other options.

              risk-warning

              Blockage of arteries in the heart

              • Risk factors: High blood sugar | High blood pressure | High cholesterol

                Rarely, Nubeqa (darolutamide) can cause blockage of the arteries in the heart (ischemic heart disease). When this happens it can lead to a heart attack. Your provider might monitor you for symptoms of heart problems during treatment. Let your provider know immediately if you have chest pain or discomfort at rest or with activity, or shortness of breath. These can be symptoms of heart problems.

                risk-warning

                Seizure

                • Risk factors: Taking other medications that can raise the risk of seizures | Past seizures | Other risk factors of seizures

                  Though rare, Nubeqa (darolutamide) might put you at risk for seizures. Seizures can occur as early as 5 weeks after you start taking this medication. Let your provider know if you have a history of seizures or conditions that raise your risk of seizures, or are taking medications that can make you more likely to have a seizure. Let your loved ones and caregivers know of this risk so they can help you and also get medical help if you do have a seizure. Stop taking Nubeqa (darolutamide) and tell your provider right away if you think you've had a seizure while on treatment because most likely you’ll need to switch to a different medication to treat your prostate cancer. Some early symptoms of a seizure can include having a strange sense of taste or smell, anxiety, nausea, or a fluttering sensation.

                  risk-warning

                  Possible harm to unborn baby

                  It’s possible for Nubeqa (darolutamide) to harm unborn babies.
                  If your partner is able to become pregnant, you should use birth control measures, such as condoms, while taking Nubeqa (darolutamide) and for 1 week after your last dose. Let your provider know right away if your partner becomes pregnant during this time.

                  dosage

                  Nubeqa (darolutamide) dosage forms

                  Typical dosing for Nubeqa (darolutamide)

                  Adults: The typical dose is 600 mg taken by mouth twice a day.

                  Your dose might be different if you have kidney or liver problems.

                  alternatives

                  What are alternatives to Nubeqa (darolutamide)?

                  There are a number of medications that your doctor can prescribe in place of Nubeqa (darolutamide). Compare a few possible alternatives below.
                  Nubeqa (darolutamide)
                  Used for:
                  Used for:
                  • Advanced or metastatic prostate cancer (cancer that've spread to other areas)

                  Used for:
                  • Advanced or metastatic prostate cancer

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                  References

                  Best studies we found

                  American Cancer Society. (2019). Chemotherapy safety.

                  American Cancer Society. (2023). Hormone therapy for prostate cancer.

                  American Heart Association. (2022). Silent ischemia and ischemic heart disease.

                  View All References (6)

                  Bayer HealthCare Pharmaceuticals Inc. (2023). Nubia- darolutamide tablet, film coated [package insert]. DailyMed.

                  National Cancer Institute. (n.d.). Antiandrogen.

                  National Cancer Institute. (n.d.). Hormone-sensitive prostate cancer.

                  National Comprehensive Cancer Network. (2024). Advanced-stage prostate cancer.

                  Park, S. J., et al. (2022). Comparison of second-generation antiandrogens for the treatment of prostate cancer. Journal of Hematology Oncology Pharmacy.

                  Schacter, S. C. (n.d.). What are the risk factors of seizures? Epilepsy Foundation.

                  GoodRx Health has strict sourcing policies and relies on primary sources such as medical organizations, governmental agencies, academic institutions, and peer-reviewed scientific journals. Learn more about how we ensure our content is accurate, thorough, and unbiased by reading our editorial guidelines.
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