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Active substance: Darolutamide. Indication: NUBEQA, in combination with docetaxel and androgen deprivation therapy (ADT), is indicated for the treatment of adult patients with metastatic hormone-sensitive prostate cancer (mHSPC), for whom docetaxel therapy is indicated. NUBEQA, in combination with ADT, is indicated for the treatment of adult patients with non-metastatic, castration-resistant prostate cancer (nmCRPC), for those who are at high risk of developing metastases (especially with a PSADT ≤ 10 months). Dosage/Administration: 600 mg (two 300-mg film-coated tablets) taken twice daily with a meal (total daily dose of 1200 mg). Patients receiving NUBEQA should also receive an LHRH analogue concurrently or have had a bilateral orchiectomy. Patients with mHSPC should start treatment with NUBEQA in combination with six cycles of docetaxel. Contraindications: Hypersensitivity to the active pharmaceutical ingredient or to one of the excipients. Women who are pregnant or of childbearing potential. Special warnings/precautions for use: Renal/hepatic impairment: Closely monitor patients with severe renal impairment or moderate/severe hepatic impairment for adverse reactions. Hepatotoxicity: In case of liver function test abnormalities suggestive of idiosyncratic DILI, NUBEQA must be permanently discontinued. ADT can prolong the QT interval: In case of risk factors or concomitant medication that prolong the QT interval, ECG monitoring should be considered. Contraception: Sexually active patients must use a highly effective form of contraception. Bone density: may be affected during treatment with NUBEQA due to long-term testosterone suppression. Recent cariovascular disease: The safety of NUBEQA in patients with a clinically relevant cardiovascular disease in the last six months has not been proven, follow current guidelines. The prescribed dose is practically “sodium free”. Do not take if you have hereditary galactose intolerance, total lactase deficiency, or glucose-galactose malabsorption. Adverse effects: NUBEQA: Very common: Neutrophil count decreased, AST increased, bilirubin increased, fatigue. Common: Ischaemic heart disease, cardiac failure, rash, pain in extremities, musculoskeletal pain, fractures. NUBEQA in combination with docetaxel: Very common: Hypertension including occasional hypertensive emergency, AST increased, ALT increased, bilirubin increased, rash. Interactions: BCRP inhibitor, OATP 1B1 and 1B3, in the case of concurrent use with corresponding substrates, follow the recommendations in the respective prescribing information. Weak CYP3A4 inducer. Substrate of CYP3A4, P-gp, and BCRP. Use of strong CYP3A4 inducers and P-gp inducers during treatment with NUBEQA should be avoided. Dispensing category: B. Authorization holder: Bayer (Schweiz) AG, Uetlibergstrasse 132, 8045 Zurich. 
For detailed information, please refer to the published medicinal product information at www.swissmedicinfo.ch. 
MA-M_DAR-CH-0241-1 07/2024