Understanding Darolutamide (Nubeqa): Uses, Dosing, and Safety Information

What Is Darolutamide?

Darolutamide (pronounced [DAR oh LOO ta mide]) is also known by the brand name, Nubeqa. It is an antineoplastic (anticancer) medication known as an androgen receptor inhibitor (sometimes grouped with antiandrogens). It works by blocking the androgen (testosterone) receptor to slow prostate cancer growth.

What Kind of Cancer Therapy Is Nubeqa?

Nubeqa is a type of hormone-targeting therapy (androgen receptor inhibitor). It does not work like traditional cytotoxic chemotherapy.

Safe Handling Precautions

Because Nubeqa is an anticancer medication, follow safe-handling precautions. Do not crush, break, or open the tablets. If a tablet is damaged, avoid direct contact; caregivers may consider wearing gloves when handling broken tablets and should wash their hands after handling. Follow your clinic/pharmacy’s hazardous drug handling guidance (e.g., USP <800>). If you need help taking the tablet, ask your pharmacist for safe-handling tips.

How Is Nubeqa Used?

Nubeqa is FDA-approved to treat certain types of prostate cancer, including non-metastatic castration-resistant prostate cancer (nmCRPC) and metastatic castration-sensitive prostate cancer (mCSPC) in specific settings. When used in conjunction with other treatments, Nubeqa can help slow cancer growth and reduce the risk of spread or progression, depending on the clinical setting. Using this drug, men in certain stages of the disease can remain symptom-free for longer periods of time.

PSA tests are one way your provider may monitor response, along with scans and symptoms when appropriate. Nubeqa is most commonly used in conjunction with a gonadotropin-releasing hormone (GnRH) analog to help the body inhibit the production of certain hormones (like testosterone). Your prescriber will tell you whether Nubeqa is being used with androgen deprivation therapy (ADT) alone or as part of a combination regimen. Some of the common GnRH analogs are histrelin (Vantas), triptorelin (Trelstar), goserelin (Zoladex), and leuprolide (Lupron Depot).

Available Formulations

Nubeqa is only available as tablets and must be administered orally. The tablets are only available in 300 mg strength. The tablets are oval-shaped, white, and marked with “300” on one side and “BAYER” on the other side. Nubeqa is commonly taken twice daily with food. Your provider will determine the exact dosing for your situation.

Directions for Use

Nubeqa must be taken with food. When taking the pill, swallow it whole; do not open, break, crush, chew, or allow it to dissolve in your mouth.

Missed Dose

If you accidentally miss a dose, take it as soon as possible prior to the next scheduled dose. Do not take two doses at the same time to make up for a missed dose.

Storage

Store pills in a cool, dry place at room temperature and ensure the bottle is tightly closed.

What To Avoid While Taking Nubeqa?

While on Nubeqa therapy, you must follow some precautions. Always tell your physician about any medications you are already taking. Do not take any drug or medicine (even herbals or over-the-counter medications) without prior consent from your physician or pharmacist, as they may have significant interactions with Nubeqa. Tell your provider about any planned vaccines. Your oncology team can advise what is appropriate based on your overall treatment plan.

Pregnancy and Nubeqa

This drug is not approved for females. Males with female partners who can become pregnant should use effective contraception during treatment and for 1 week after the last dose as Nubeqa may cause fetal harm.

Side Effects

As with any other medication, you may encounter many side effects while taking Nubeqa. A few things to keep in mind are:

• You may not have all the side effects listed below. Many people may experience little to no side effects.
• The severity of side effects may vary from person to person, so don’t compare your side effects with other people’s experiences.
• Most of the side effects will improve when therapy is discontinued.
• These side effects are easily manageable most of the time, either by readjusting the dose of Nubeqa or using additional medications to treat the symptoms. Consult with your physician or pharmacist to explore available options.
• Do not hide any symptoms; when you feel any discomfort, do not hesitate to tell your physician or pharmacist about it. 

Note: This is not a comprehensive list of all side effects. Talk to your doctor if you have questions.

Some of the most common side effects of Nubeqa are:  

Pain in the Extremities

Nubeqa has the potential to cause pain in the extremities (hands and feet). This may feel like aching, soreness, or discomfort in the arms or legs. It is not the same as carpal tunnel syndrome. If you experience bothersome pain in your hands, feet, arms, or legs, you should consult your physician on how to treat this side effect.

Tiredness and Fatigue

Feelings of extreme tiredness and fatigue may occur. This side effect may appear suddenly and sometimes may not go away with rest. Light and regular exercise is recommended, along with adequate sleep. Start with simple activities like walking, then gradually work up to light jogging, slow running, etc. Fatigue may also be associated with anemia, depression, and anxiety. Find ways to relieve anxiety and depression by engaging in positive activities. Fatigue may sometimes lead to falling and/or fractures. If fatigue symptoms become unmanageable or severe, inform your physician.

Urinary Retention

Urinary retention is the inability to empty your bladder completely. It may present as the need to urinate more frequently, trouble urinating, or urinary incontinence (the inability to control when to urinate). Contact your doctor right away if you notice any signs or symptoms of urinary retention while taking Nubeqa.

Cardiac Complications

There is a risk that Nubeqa may raise blood pressure. This side effect may typically present as a very bad headache or dizziness, passing out, or a change in eyesight. High blood pressure and heart-related events have been reported. Your provider may monitor your blood pressure and heart health, especially if you have a history of heart disease. Get urgent medical help for chest pain, sudden shortness of breath, coughing up blood, one-sided leg swelling, or sudden trouble speaking. Typically, these side effects can be controlled with lifestyle changes or medications to treat high blood pressure. While being treated with Nubeqa, blood pressure should be monitored regularly at each office visit.

Lab Changes and Monitoring

Your provider may check blood tests during treatment. Nubeqa can be associated with lab changes such as increased liver enzymes and decreases in some blood cell counts (including neutrophils). Keep all scheduled lab appointments and contact your care team if you develop signs of infection (fever, chills) or unusual bruising/bleeding.

Other common side effects may include:

• Rash
• Falls and fractures
• Diarrhea
• Nausea
• Increased liver enzymes

Precautions

Unless approved by your physician, Nubeqa is generally not recommended for: 

• Patients who have an allergy to Nubeqa or any component of the formulation.
• Patients with severe liver or kidney impairment. Dose reduction may be required.
• Patients with a risk of high blood pressure or a history of heart disease. Blood pressure should be monitored regularly.

FAQs

Is Nubeqa a chemo agent?

Nubeqa is not traditional “chemotherapy” (cytotoxic chemo). It is an androgen receptor inhibitor used to treat certain types of prostate cancer.

What is the best time to take Nubeqa?

Nubeqa must be taken with food. When taking the pill, swallow it whole; do not open, break, crush, chew, or allow it to dissolve in your mouth. It is typically dosed twice a day (12 hours apart).

Is Darolutamide available as a generic?

There is currently no generic version of darolutamide. However, generic availability can change over time. Ask your pharmacist whether a generic darolutamide is available.