治療非轉移性去勢抗性前列腺癌(nmCRPC)的病病；與docetaxel併併於治療轉移性的去勢敏感性前列腺癌(mCSPC，又稱mHSPC)的病病病

Antineoplastic Agent, Antiandrogen

Distribution: 119 L; darolutamide has low blood-brain barrier penetration.
Protein binding: 92%.
Metabolism: Primarily metabolized by CYP3A4, as well as by UGT1A9 and UGT1A1; active metabolite is ketodarolutamide.
Bioavailability: ~30%.
Half-life elimination: ~20 hours.
Time to peak: ~4 hours.
Excretion: Urine: 63.4%; feces: 32.4%.
Clearance: 116 mL/minute.

Hypersensitivity to darolutamide or any component of the formulation.

Darolutamide may cause fetal harm and pregnancy loss if utero exposure occurs.

>10%: decreased neutrophils (20%), Increased serum aspartate aminotransferase (23%), increased serum bilirubin (16%), asthenia (≤ 16%), fatigue (≤ 16%).
1% to 10%: heart failure (2%), ischemic heart disease (4%), skin rash (4%), limb pain (6%).

Prostate cancer, metastatic, hormone sensitive (mCSPC):
600 mg twice daily (in combination with docetaxel); continue until disease progression or unacceptable toxicity. Administer the first 6 cycles of docetaxel within 6 weeks after initiating darolutamide.
Prostate cancer, nonmetastatic, castration resistant (nmCRPC):
600 mg twice daily; continue until disease progression or unacceptable toxicity.

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Dosage adjustment for concomitant therapy:
If the patient experiences grade 3 or higher toxicity or intolerable NUBEQAA-related adverse reactions, dosing should be suspended or be reduced to 300 mg twice daily until symptoms improve, then the therapeutic dose can be resumed to 600 mg twice daily.

eGFR 30 to 89 mL/minute/1.73 m2: No dosage adjustment necessary.
eGFR 15 to 29 mL/minute/1.73 m2 (not receiving hemodialysis): reduce the dose to 300 mg twice daily.

Mild impairment (Child-Pugh class A): No dosage adjustment necessary.
Moderate impairment (Child-Pugh class B): Reduce the dose to 300 mg twice daily.