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NUBEQA (darolutamide) Dosing

What is the standard NUBEQA (darolutamide) dose for my eligible patient and when should they take their NUBEQA (darolutamide) tablets?

NUBEQA 600 mg twice daily + ADT

* Treatment with NUBEQA should be continued until disease progression or unacceptable toxicity even if a cycle of docetaxel is delayed, interrupted, or discontinued.

Special populations & missed NUBEQA dosing

Renal impairment

Hepatic impairment

Missed doses

Elderly

Paediatric populations

  • No dose adjustment is necessary for patients with mild or moderate renal impairment
  • For patients with severe renal impairment (eGFR 15–29 mL/min/1.73 m2) not receiving haemodialysis, the recommended starting dose is 300 mg twice daily
  • As exposure might be increased those patients should be closely monitored for adverse reactions
  • No dose adjustment is necessary for patients with mild hepatic impairment
  • Available data on NUBEQA pharmacokinetics in moderate hepatic impairment is limited. NUBEQA has not been studied in patients with severe hepatic impairment. As exposure might be increased those patients should be closely monitored for adverse reactions.
  • For patients with moderate and severe hepatic impairment (Child-Pugh Classes B and C), a starting dose of 300 mg twice daily is recommended
  • If a dose is missed, the dose should be taken as soon as the patient remembers prior to the next scheduled dose
  • The patient should not take two doses together to make up for a missed dose
  • No dose adjustment is necessary in elderly patients
  • There is no relevant use of darolutamide in the paediatric population

Refer to full Summary of Product Characteristics (SmPC) before prescribing.

TREAT YOUR ELIGIBLE PATIENTS WITH NUBEQA

>90% patients were treated across three Phase III studies without a dose reduction

>90% patients were treated across three Phase III studies without a dose reduction

Treat with confidence: Does NUBEQA interact with my patient’s medications?

NUBEQA interacts with fewer drugs versus other second generation ARIs, offering confidence when treating patients who require concomitant medications

Guidelines

Abbreviations

ADT, androgen deprivation therapy; ARI, androgen receptor inhibitor; mHSPC, metastatic hormone-sensitive prostate cancer; nmCRPC, non-metastatic castration-resistant prostate cancer.

 

PP-NUB-GB-2546 | August 2025

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