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Darolutamide Dosage

Medically reviewed by Drugs.com. Last updated on Sep 18, 2019.

Applies to the following strengths: 300 mg

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 hepatic impairment (Child-Pugh A): No adjustments recommended.
-Moderate hepatic impairment (Child-Pugh B): 300 mg orally 2 times a day
-Severe hepatic impairment (Child-Pugh C): 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; so 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.

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