Nubeqa
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.
What is Nubeqa (darolutamide)?
What is Nubeqa (darolutamide) used for?
Castration-resistant prostate cancer that hasn’t yet spread to other areas of the body
Metastatic, hormone-sensitive prostate cancer, given together with a chemotherapy called docetaxel (Taxotere)
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.
Drug Facts
What are the side effects of Nubeqa (darolutamide)?
Common Side Effects
- Higher liver labs (up to 23%)
- Lower white blood cell count (20%)
- Extreme tiredness (16%)
- 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
Other Side Effects
- Rash
- Pain in arms or legs
- Muscle pain
- Lung infection (pneumonia)
Serious Side Effects
- 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:
- Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat
- Heart attack—pain or tightness in the chest, shoulders, arms, or jaw, nausea, shortness of breath, cold or clammy skin, feeling faint or lightheaded
- Seizures
Side effects that usually do not require medical attention (report these to your care team if they continue or are bothersome):
Pros and cons of Nubeqa (darolutamide)
Pros
Recommended option for certain types of prostate cancer
Can treat prostate cancer that is no longer responding to other hormonal therapies
Might cause fewer side effects than other newer antiandrogen medications, such as Erleada (apalutamide) and Xtandi (enzalutamide)
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 for Nubeqa (darolutamide)
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.
Frequently asked questions about Nubeqa (darolutamide)
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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.
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.
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.
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.
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.
What are alternatives to Nubeqa (darolutamide)?
Castration-resistant prostate cancer that hasn’t yet spread to other areas of the body
Metastatic, hormone-sensitive prostate cancer, given together with a chemotherapy called docetaxel (Taxotere)
Advanced or metastatic prostate cancer (cancer that've spread to other areas)
What is the latest news about Nubeqa (darolutamide)?
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References
Best studies we foundAmerican Cancer Society. (2019). Chemotherapy safety.
American Cancer Society. (2023). Hormone therapy for prostate cancer.
American Heart Association. (2022). Silent ischemia and ischemic heart disease.
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.
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