Nubeqa Dosage for Non-Metastatic Castration-Resistant Prostate Cancer
The recommended dosage of Nubeqa (darolutamide) is 600 mg (two 300 mg tablets) administered orally twice daily with food, while continuing concurrent androgen deprivation therapy (ADT). 1
Standard Dosing Regimen
- Take 600 mg twice daily (total daily dose of 1200 mg), which equals two 300 mg tablets per dose 1
- Swallow tablets whole with food 1
- Continue ADT concurrently with a gonadotropin-releasing hormone (GnRH) analog or have had bilateral orchiectomy 1
- Treatment duration: Continue until disease progression or unacceptable toxicity 2
Dose Modifications for Special Populations
Severe Renal Impairment
- For patients with severe renal impairment (eGFR 15-29 mL/min/1.73 m² not on hemodialysis), reduce dose to 300 mg twice daily 1
Moderate Hepatic Impairment
- For patients with moderate hepatic impairment (Child-Pugh Class B), reduce dose to 300 mg twice daily 1
Normal Renal and Hepatic Function
- No dose adjustment needed for mild renal or hepatic impairment 1
Administration Details
- Timing: Administer at approximately the same times each day 1
- Food requirement: Must be taken with food to ensure proper absorption 1
- Missed dose: If a dose is missed, take the next dose at the regularly scheduled time; do not double up 1
Clinical Evidence Supporting This Dosing
The ARAMIS trial established this dosing regimen in 1,509 patients with non-metastatic castration-resistant prostate cancer, demonstrating that darolutamide 600 mg twice daily significantly prolonged metastasis-free survival to 40.4 months compared with 18.4 months for placebo (hazard ratio 0.41; 95% CI, 0.34-0.50; P<0.001) 2. This benefit was consistent regardless of PSA doubling time, including patients with PSADT >6 months 3.
Safety Monitoring
- Cardiovascular monitoring: Optimize management of cardiovascular risk factors and monitor for signs of ischemic heart disease, as Grade 3-4 ischemic events occurred in 1.7% of patients 1
- Seizure risk: Monitor for seizures (occurred in 0.2% of patients); consider discontinuation if seizure develops 1
- Discontinuation rate: Only 8.9% of patients discontinued due to adverse events, similar to placebo (8.7%) 2
Common Pitfalls to Avoid
- Do not reduce the dose empirically without specific indications (severe renal or moderate hepatic impairment) 1
- Do not discontinue ADT when starting darolutamide; concurrent ADT is mandatory 1
- Do not skip the food requirement; darolutamide must be taken with food for proper absorption 1
- Do not confuse with other androgen receptor inhibitors: Unlike enzalutamide (160 mg once daily) or apalutamide (240 mg once daily), darolutamide requires twice-daily dosing 4, 1
Long-Term Tolerability
Darolutamide has demonstrated excellent long-term tolerability, with patients safely treated for a median of 38 months showing no new safety signals and mostly grade 1-2 adverse events 5. The incidence of adverse events commonly associated with other androgen receptor inhibitors (fractures, falls, hypertension, cognitive impairment) was similar to placebo 3, 2.