Castration resistant prostate cancer (nmCRPC)

Active Ingredient: Darolutamide

Indication for Darolutamide

Population group: only adults (18 years old or older)

Darolutamide is indicated for the treatment of adult men with non-metastatic castration resistant prostate cancer (nmCRPC) who are at high risk of developing metastatic disease.

For this indication, competent medicine agencies globally authorize below treatments:

1,200 mg in 2 divided doses daily

Route of admnistration

Oral

Defined daily dose

1,200 - 1,200 mg

Dosage regimen

From 600 To 600 mg 2 time(s) per day every day

Detailed description

The recommended dose is 600 mg darolutamide taken twice daily, equivalent to a total daily dose of 1200 mg.

Medical castration with a luteinising hormone-releasing hormone (LHRH) analogue should be continued during treatment of patients not surgically castrated.

Missed dose

If a dose is missed, the dose should be taken as soon as the patient remembers prior to the next scheduled dose. The patient should not take two doses together to make up for a missed dose.

Dose modification

If a patient experiences a ≥ Grade 3 toxicity or an intolerable adverse reaction, dosing should be withheld or reduced to 300 mg twice daily until symptoms improve. Treatment may then be resumed at a dose of 600 mg twice daily.

Dose reduction below 300 mg twice daily is not recommended, because efficacy has not been established.

Active ingredient

Darolutamide

Darolutamide is an androgen receptor (AR) inhibitor with a flexible polar-substituted pyrazole structure that binds with high affinity directly to the receptor ligand binding domain. Darolutamide competitively inhibits androgen binding, AR nuclear translocation, and AR mediated transcription. A major metabolite, keto-darolutamide, exhibited similar in vitro activity to darolutamide. Darolutamide treatment decreases prostate tumour cell proliferation leading to potent antitumour activity.

Read more about Darolutamide

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