Nubeqa Dosage & Drug Information

Concise Prescribing Info

Contents

Darolutamide

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Indications/Uses

Adult men w/ nonmetastatic castration-resistant prostate cancer (nmCRPC) who are at high risk of developing metastatic disease; metastatic hormone-sensitive prostate cancer (mHSPC) in combination w/ docetaxel.

Dosage/Direction for Use

Adult nmCRPC & mHSPC 600 mg bd. mHSPC In combination w/ docetaxel: Administer 1st 6 cycles of docetaxel w/in 6 wk after start of darolutamide. Patient experiencing ≥grade 3 toxicity or intolerable AR W/hold or reduce dose to 300 mg bd until symptoms improve. Moderate hepatic & severe renal impairment (eGFR 15-29 mL/min/1.73 m²) not receiving haemodialysis Starting dose: 300 mg bd.

Administration

Should be taken with food: Swallow whole.

Contraindications

Hypersensitivity. Women who are or may become pregnant.

MIMS Class

Cancer Hormone Therapy

ATC Classification

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

Regulatory Classification

POM

Presentation/Packing

Form

Nubeqa FC tab 300 mg

Packing/Price

1's

Nubeqa

darolutamide

Manufacturer:

Orion