NUBEQA FILM-COATED TABLET 300MG

4.1 Therapeutic indications

NUBEQA is indicated for the treatment of adult men with

• nonmetastatic castration resistant prostate cancer (nmCRPC) who are at high risk of developing metastatic disease (see section 5.1 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).
• metastatic hormone-sensitive prostate cancer (mHSPC) in combination with docetaxel. (see section 5.1 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

4.3 Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.

Women who are or may become pregnant (see section 4.6 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

4.2 Posology and method of administration

nmCRPC and mHSPC

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 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

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.

mHSPC

mHSPC patients should start darolutamide in combination with docetaxel (see section 5.1 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). The first of 6 cycles of docetaxel should be administered within 6 weeks after the start of darolutamide treatment. The recommendations 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 section 4.8 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information), 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 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

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 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

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 hepatic impairment (Child-Pugh Class B), the recommended starting dose is 300 mg twice daily (see sections 4.4 and 5.2 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

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 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).