Source: European Medicines Agency (EU) Revision Year: 2021 Publisher: Bayer AG, 51368, Leverkusen, Germany
NUBEQA is indicated for the treatment of adult men with non-metastatic castration resistant prostate cancer (nmCRPC) who are at high risk of developing metastatic disease (see section 5.1).
Treatment should be initiated and supervised by a specialist physician experienced in treatment of prostate cancer.
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).
Medical castration with a luteinising hormone-releasing hormone (LHRH) analogue should be continued during treatment of patients not surgically castrated.
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.
If a patient experiences a ≥ Grade 3 toxicity or an intolerable adverse reaction (see section 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.
No dose adjustment is necessary in elderly patients (see section 5.2).
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).
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.).
There is no relevant use of darolutamide in the paediatric population for the indication of treatment of nmCRPC.
NUBEQA is for oral use.
The tablets should be taken whole with food (see section 5.2).
The highest dose of darolutamide studied clinically was 900 mg twice daily, equivalent to a total daily dose of 1800 mg. No dose limiting toxicities were observed with this dose.
Considering the saturable absorption (see section 5.2) and the absence of evidence for acute toxicity, an intake of a higher than recommended dose of darolutamide is not expected to lead to toxicity.
In the event of intake of a higher than recommended dose, treatment with darolutamide can be continued with the next dose as scheduled.
There is no specific antidote for darolutamide and symptoms of overdose are not established.
Shelf life: 3 years.
This medicinal product does not require any special storage conditions.
PVC/Aluminium foil blisters containing 16 film-coated tablets.
Each pack contains 96 or 112 film-coated tablets.
Not all pack sizes may be marketed.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
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