Active Ingredient: Darolutamide
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:
For:
Oral, 600 milligrams darolutamide, 2 times daily to meals.
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.
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.
If a patient experiences a ≥ Grade 3 toxicity or an intolerable adverse reaction related to darolutamide, 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.
It should be taken with food.
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