Darolutamide Dosage

Medically reviewed by Drugs.com. Last updated on Sep 14, 2023.

Usual Adult Dose for Prostate Cancer

600 mg orally 2 times a day

Comments:

• Patients receiving this drug should also receive a gonadotropin-releasing hormone (GnRH) analog concurrently or should have had a bilateral orchiectomy.

Use: For nonmetastatic castration resistant prostate cancer (nmCRPC)

Renal Dose Adjustments

Mild to moderate renal impairment (CrCl 30 to 89 mL/min): No adjustment recommended.
Severe renal impairment (CrCl 15 to 29 mL/min) who are not receiving hemodialysis: 300 mg orally 2 times a day
End stage renal disease (CrCl 15 mL/min or less): Data not available

Liver Dose Adjustments

Mild (Child-Pugh A) hepatic impairment: No adjustment recommended.
Moderate (Child-Pugh B) hepatic impairment: 300 mg orally 2 times daily
Severe (Child-Pugh C) hepatic impairment: Data not available

Dose Adjustments

Grade 3 or greater toxicity or an intolerable adverse reaction: Withhold therapy or reduce to the dose to 300 mg 2 times a day until symptoms improve; then resume therapy at 600 mg orally 2 times a day.
Dose reduction below 300 mg orally 2 times a day is not recommended.

Precautions

CONTRAINDICATIONS:

• None

Safety and efficacy have not been established in patients younger than 18 years.

Consult WARNINGS section for additional precautions.

Dialysis

Data not available

Other Comments

Administration advice:

• This drug should be taken with food.
• Swallow tablets whole; do not divide, crush, or chew.
• If a dose is missed it should be taken as soon as it is remembered prior to the next scheduled dose; do not take 2 doses together to make up for a missed dose.

Storage requirements:

• Store at 20C to 25C (68F to 77F); excursions permitted between 15C and 30C (59F and 86F).
• Keep the bottle tightly closed after first opening.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Medical Disclaimer