Treatment should be initiated and supervised by a specialist physician experienced in treatment of prostate cancer.
Posology: The recommended dose is 600 mg darolutamide (two tablets of 300 mg) taken twice daily, equivalent to a total daily dose of 1200 mg (see Pharmacology: Pharmacokinetics under Actions).
Medical castration with a luteinising hormone-releasing hormone (LHRH) analogue should be continued during treatment of patients not surgically castrated.
Missed dose: 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.
Dose modification: If a patient experiences a ≥ Grade 3 toxicity or an intolerable adverse reaction (see Adverse Reactions), dosing should be withheld or reduced to 300 mg twice daily until symptoms improve. Treatment may then be resumed at a dose of 600 mg twice daily.
Dose reduction below 300 mg twice daily is not recommended, because efficacy has not been established.
Special populations: Elderly: No dose adjustment is necessary in elderly patients (see Pharmacology: Pharmacokinetics under Actions).
Renal impairment: 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 (see Pharmacology: Pharmacokinetics under Actions; and Precautions).
Hepatic impairment: No dose adjustment is necessary for patients with mild hepatic impairment.
The available data on darolutamide pharmacokinetics in moderate hepatic impairment is limited.
Darolutamide has not been studied in patients with severe hepatic impairment.
For patients with moderate and severe hepatic impairment (Child-Pugh Classes B and C), the recommended starting dose is 300 mg twice daily (see Pharmacology: Pharmacokinetics under Actions; and Precautions).
Paediatric population: There is no relevant use of darolutamide in the paediatric population for the indication of treatment of nmCRPC.
Method of administration: NUBEQA is for oral use.
The tablets should be taken whole with food (see Pharmacology: Pharmacokinetics under Actions).