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Short product information NUBEQA®AS.: Darolutamide. I.: NUBEQA is indicated in comb. with androgen deprivation therapy (ADT) for the treatm. of adult pat. with metastatic hormone-sensitive prostate cancer (mHSPC). NUBEQA is indicated in comb. with docetaxel and ADT for the treatm. of adult pat. with mHSPC, for whom docetaxel therapy is indicated. NUBEQA is indicated in comb. with ADT for the treatm. of adult pat. with non-metastatic, castration-resistant prostate cancer (nmCRPC), for those who are at high risk of develop. metastases (especially with a PSA-DT ≤ 10 m.). D/A: 600 mg (two 300 mg film-coated tablets) taken 2/day with a meal (total daily dose of 1200 mg). pat. receiving NUBEQA should also receive an LHRH agonist or antagonist concurrently or have had a bilat. orchiectomy. When used in comb. with docetaxel, the 1. of 6 docetaxel cycles should begin within 6 weeks of starting NUBEQA. CI.: Hypersensitivity to the active pharmaceut. ingredient or to one of the excipients. Women who are pregnant or of childbearing potential. Spec.W./Prec.: Renal/hepatic impairment: Closely monitor pat. with severe renal impair. or moderate/severe hepatic impair. for adverse reactions. Hepatotox.: In case of liver funct. test abnormalities suggestive of idiosyncr. DILI, NUBEQA must be permanently discont. ADT can prolong the QT interval: In case of risk factors or concomitant medication that prolong the QT interval, ECG monitoring should be consid.. Contraception: Sexually active pat. must use a highly effective form of contracept.. Bone density: may be affected during treatm. with NUBEQA due to long-term testosterone suppr. Recent cardiovasc. disease: The safety of NUBEQA in pat. with a clinic. relevant cardiovasc. disease in the last 6 months has not been proven, follow current guidelines. The prescr. dose is practically “sodium free”. Do not take if you have hereditary galactose intolerance, total lactase deficiency, or glucose-galactose malabsorption. AEs.: NUBEQA: Very common: Neutrophil count decr., AST and ALT incr., bilirubin incr., fatigue. Common: Ischaemic heart disease, cardiac failure, rash, pain in extremities, fractures. NUBEQA in comb. with docetaxel: Very common: Hypertension including occasional hypertensive emergency, AST incr., ALT incr., bilirubin incr., rash. Interactions: BCRP inhibitor, OATP 1B1 and 1B3, in the case of concurrent use with corresp. substrates, follow the recommendations in the resp. prescrib. information. Weak CYP3A4 inducer. Substrate of CYP3A4, P-gp, and BCRP. Use of strong CYP3A4 inducers and P-gp inducers during treatm. with NUBEQA should be avoided. UE: Very common: Neutrophil count decreased, AST and ALT increased, Bilirubin increased, Fatigue. Common: Ischaemic heart disease, Cardiac failure, Rash, Pain in extremities, Fractures. NUBEQA in combination with Docetaxel: Very common: Hypertension including hypertensive emergency, AST increased, ALT increased, Bilirubin increased, Rash. List: B. Bayer (Schweiz) AG, 8045 Zurich. Further inform.: <a href="https://www.swissmedicinfo-pro.ch/">https://www.swissmedicinfo-pro.ch/</a> RP-M_DAR-CH-0108-4 02/2026

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