Nubeqa (darolutamide) is taken continuously until the cancer progresses or side effects become too severe to manage. There is no predetermined number of months or cycles. For some people, that means staying on the medication for years.
Why There’s No Fixed Timeline
Unlike chemotherapy, which is given in a set number of rounds, Nubeqa works by blocking the signals that fuel prostate cancer growth. As long as it’s keeping the disease stable and you’re tolerating it, the treatment continues. The FDA-approved prescribing guidance is straightforward: take Nubeqa “until disease progression or unacceptable toxicity.”
This open-ended approach is standard for drugs in this class. Your oncologist will monitor your PSA levels, imaging scans, and overall health at regular intervals to determine whether the medication is still working. If the cancer starts growing again or the side effects outweigh the benefits, that’s when treatment stops or changes.
What Treatment Looks Like Day to Day
The standard dose is 600 mg twice a day, which means taking two 300 mg tablets in the morning and two more in the evening, for a total daily dose of 1,200 mg. You need to take the tablets with food, as this helps your body absorb the medication properly. Swallow them whole rather than crushing or splitting them.
Because treatment is ongoing, consistency matters. Missing doses or taking them on an empty stomach can reduce how well the drug works. Many people find it easiest to tie each dose to a regular meal, like breakfast and dinner.
How Long People Typically Stay on It
Nubeqa is approved for two types of prostate cancer: non-metastatic castration-resistant prostate cancer (nmCRPC), where the cancer hasn’t visibly spread but PSA levels are rising despite hormone therapy, and metastatic hormone-sensitive prostate cancer (mHSPC), where the cancer has spread but still responds to hormone treatment. The duration of treatment can differ between these two situations.
In clinical trials for nmCRPC, the median time patients remained on Nubeqa was roughly 14 to 18 months before disease progression occurred, though many continued well beyond that. For mHSPC, Nubeqa is used alongside a chemotherapy agent called docetaxel and standard hormone therapy, and treatment with Nubeqa continues after the chemotherapy rounds are completed. In both cases, individual outcomes vary widely. Some people stay on the drug for several years with stable disease.
Side Effects That Can Shorten Treatment
Most people tolerate Nubeqa relatively well compared to other prostate cancer treatments, but side effects can still lead to dose adjustments or stopping the drug. The most commonly reported issues include fatigue, pain in the arms or legs, and rash. Some people also develop changes in liver function, which show up as elevated enzyme levels on blood tests.
If side effects become significant, your doctor may temporarily pause the medication or reduce the dose rather than stopping it entirely. A dose reduction lets you continue getting some benefit from the drug while giving your body a chance to recover. Complete discontinuation for toxicity is typically reserved for severe or persistent reactions that don’t improve with a lower dose or a treatment break.
What Triggers the Decision to Stop
The two main reasons treatment ends are disease progression and intolerable side effects. Disease progression usually means one of two things: imaging scans show the cancer is growing or spreading to new areas, or PSA levels are consistently rising in a pattern that indicates the drug is no longer controlling the disease. Your oncologist will use a combination of blood work, scans, and how you’re feeling physically to make this call.
A single rising PSA reading doesn’t necessarily mean treatment is failing. PSA levels can fluctuate for various reasons, and doctors typically look for a sustained trend before making changes. This is why regular follow-up appointments are essential throughout treatment.
Managing the Cost of Long-Term Treatment
Because Nubeqa is taken indefinitely, cost is a real concern. Bayer, the manufacturer, offers several financial support options through a program called Access Services by Bayer. Commercially insured patients may qualify for a co-pay program that reduces out-of-pocket costs to as little as $0, with savings of up to $25,000 per year. The program includes automatic annual re-enrollment so there are no gaps in coverage, and there are no income requirements to qualify.
For patients just starting treatment, a free trial program provides a one-month supply at no cost. Patients on government insurance programs like Medicare or Medicaid aren’t eligible for the co-pay card but can be referred to independent charitable foundations that may help with out-of-pocket expenses. You can reach Access Services by Bayer at 1-800-288-8374 on weekdays from 9 AM to 6 PM Eastern.