Active Ingredient: Darolutamide
Darolutamide is indicated for the treatment of adult men with metastatic hormone-sensitive prostate cancer (mHSPC) in combination with docetaxel and androgen deprivation therapy.
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.
mHSPC patients should start darolutamide in combination with docetaxel. The first of 6 cycles of docetaxel should be administered within 6 weeks after the start of darolutamide treatment. The recommendation in the product information of docetaxel should be followed. Treatment with darolutamide should be continued until disease progression or unacceptable toxicity even if a cycle of docetaxel is delayed, interrupted, or discontinued.
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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