Concise Prescribing Info
Non-metastatic castration resistant prostate cancer (nmCRPC) in adult men who are at high risk of developing metastatic disease.
Dosage/Direction for Use
600 mg (two 300-mg tab) bd. Patient w/ severe renal impairment (eGFR 15-29 mL/min/1.73 m2) not receiving haemodialysis Initially 300 mg bd. Patient w/ moderate & severe hepatic impairment (Child-Pugh B & C) Initially 300 mg bd.
Should be taken with food.
Hypersensitivity. Women who are or may become pregnant.
Special Precautions
Patients w/ clinically significant CV disease in the past 6 mth including stroke, MI, severe/unstable angina pectoris, coronary/peripheral artery bypass graft, & symptomatic CHF; patients w/ history of risk factors for QT prolongation & patients concomitantly taking medicinal products that might prolong the QT interval. Not recommended w/ concomitant use of strong CYP3A4 & P-gp inducers. Patients should be monitored for adverse reactions of BCRP, OATP1B1 & OATP1B3 substrates, if concomitantly taking such products. Avoid co-administration w/ rosuvastatin. Patients w/ rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption. Patients w/ severe renal impairment or moderate to severe hepatic impairment. May cause foetal harm. Men engaging in sexual activity w/ a woman of childbearing potential should use a highly effective contraceptive method during & for 1 wk after completion of treatment. May impair fertility in males of reproductive potential.
Adverse Reactions
Fatigue/asthenic conditions; neutrophil count decreased, bilirubin increased, AST increased. Ischaemic heart disease, heart failure; rash; pain in extremity, musculoskeletal pain, fractures.
Drug Interactions
Decreased exposure & Cmax w/ strong & moderate CYP3A4 & P-gp inducers (eg, carbamazepine, phenobarb, St. John's Wort, phenytoin, rifampicin). Increased exposure w/ combined P-gp & strong CYP3A4 inhibitor. Increased exposure & Cmax of rosuvastatin. May increase plasma conc of other concomitant BCRP, OATP1B1 & OATP1B3 substrates (eg, methotrexate, sulfasalazine, fluvastatin, atorvastatin, pitavastatin). Decreased exposure & Cmax of midazolam (sensitive CYP3A4 substrate). Additive effect on QT interval w/ medicinal products known to prolong the QT interval or medicinal products able to induce Torsade de pointes eg, class IA or III antiarrhythmics, methadone, moxifloxacin, antipsychotics (eg, haloperidol).
MIMS Class
Cancer Hormone Therapy
ATC Classification
L02BB06 - darolutamide ; Belongs to the class of anti-androgens. Used in treatment of neoplastic diseases.
Nubeqa FC tab 300 mg
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