Posology : מינונים

4.2        Posology and method of administration

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 section 5.2).

Darolutamide should be continued until disease progression or unacceptable toxicity.

Medical castration with a luteinising hormone-releasing hormone (LHRH) analogue should be continued during treatment of patients not surgically castrated.


metastatic hormone-sensitive prostate cancer (mHSPC) mHSPC patients should start darolutamide in combination with docetaxel (see section 5.1). The first of 6 cycles of docetaxel should be administered within 6 weeks after the start of darolutamide treatment.
The recommendation in the product information of docetaxel should be followed. Treatment with darolutamide should be continued until disease progression or unacceptable toxicity even if a cycle of docetaxel is delayed, interrupted, or discontinued.

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 related to darolutamide (see sections 4.4 and 4.8), 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 section 5.2).
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 sections 4.4 and 5.2).

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 sections 4.4 and 5.2.).

Paediatric population
There is no relevant use of darolutamide in the paediatric population 
Method of administration

NUBEQA is for oral use.
The tablets should be taken whole with food (see section 5.2).