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The highest dose of darolutamide studied clinically was 900 mg twice daily, equivalent to a total daily dose of 1800 mg. No dose limiting toxicities were observed with this dose.
Considering the saturable absorption (see Pharmacology: Pharmacokinetics under Actions) and the absence of evidence for acute toxicity, an intake of a higher than recommended dose of darolutamide is not expected to lead to toxicity.
In the event of intake of a higher than recommended dose, treatment with darolutamide can be continued with the next dose as scheduled.
There is no specific antidote for darolutamide and symptoms of overdose are not established.
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