Nubeqa

Non-metastatic castration-resistant prostate cancer (nmCRPC) in adult men who are at high risk of developing metastatic disease. In combination w/ docetaxel & androgen deprivation therapy for metastatic hormone-sensitive prostate cancer (mHSPC) in adult men.

600 mg (two 300-mg tab) bd. In mHSPC patients, administer the 1st of 6 cycles of docetaxel w/in 6 wk after start of darolutamide treatment. 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.

Safety has not been established in 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. Permanently discontinue treatment in case of hepatic transaminase elevations suggestive of idiosyncratic drug-induced liver injury related to darolutamide. Assess benefit-risk ratio including potential for torsade de pointes prior to initiating treatment in 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. Monitor patients for adverse reactions of BCRP, OATP1B1 & OATP1B3 substrates if such medicinal products are being co-administered. Avoid co-administration w/ rosuvastatin. Should not be taken by patients w/ rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption. Limited data in patients w/ severe renal impairment; or moderate hepatic impairment. Has not been studied in patients w/ severe hepatic impairment. May cause foetal harm. Men engaging in sexual activity w/ women of childbearing potential should use highly effective contraception during & for 1 wk after completion of treatment. May impair fertility in males of reproductive potential.

Decreased neutrophil count, increased blood bilirubin, increased AST. Fractures. nmCRPC: Fatigue/asthenic conditions. Ischaemic heart disease, heart failure; rash; pain in extremity, musculoskeletal pain. mHSPC: HTN; rash; increased ALT. Gynaecomastia.

Decreased exposure & C_max 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 & C_max of rosuvastatin. Increased plasma conc of other concomitant BCRP, OATP1B1 & OATP1B3 substrates (eg, MTX, sulfasalazine, fluvastatin, atorvastatin, pitavastatin). Decreased exposure & C_max 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 (eg, quinidine, disopyramide) or III (eg, amiodarone, sotalol, dofetilide, ibutilide) antiarrhythmics, methadone, moxifloxacin, antipsychotics (eg, haloperidol).

Cancer Hormone Therapy

L02BB06 - darolutamide ; Belongs to the class of anti-androgens. Used in treatment of neoplastic diseases.

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