In the clinical studies, 88% of patients treated with darolutamide were age 65 years or older.No seizures have been observed with darolutamide in clinical trials. Darolutamide is an expected teratogen and has a theoretical risk of birth defects in male infants if taken by women during pregnancy. It may impair male fertility. When used as a monotherapy (i.e., without surgical or medical castration) in men, NSAAs are known to produce feminizing breast changes including breast tenderness and gynecomastia. Overdose
Darolutamide has been studied at a dosage of up to 1,800 mg/day in clinical trials. There were no dose-limiting toxicities seen at this dosage. Due to its saturable absorption and lack of acute toxicity, overdose of darolutamide is not expected to result in systemic toxicity in people with intact hepatic and renal function. There is no specific antidote for overdose of darolutamide. In the event of darolutamide overdose, if there is no toxicity, treatment can be continued as normal. If there is suspicion of toxicity, general supportive measures should be undertaken until clinical toxicity has decreased or resolved and then treatment may be continued. Interactions
Combined P-glycoprotein and strong or moderate CYP3A4 inducers such as rifampicin may decrease exposure to darolutamide, while combined P-glycoprotein and strong CYP3A4 inhibitors such as itraconazole may increase exposure to darolutamide. Darolutamide is an inhibitor of the breast cancer resistance protein (BCRP) transporter and can increase exposure to substrates for this protein such as rosuvastatin. It has been found to increase exposure to rosuvastatin by approximately 5-fold.
Bioethics
A person in a coma is said to be in an  unconscious state. Perspectives on personhood, identity and consciousness come into play when discussing the metaphysical and bioethical views on comas. It has been argued that unawareness should be just as ethically relevant and important as a state of awareness and that there should be metaphysical support of unawareness as a state.In the ethical discussions about disorders of consciousness (DOCs), two abilities are usually considered as central: experiencing well-being and having interest. Well-being can broadly be understood as the positive effect related to what makes life good (according to specific standards) for the individual in question. The only condition for well-being broadly considered is the ability to experience its ‘positiveness’. That said, because experiencing positiveness is a basic emotional process with phylogenetic roots, it is likely to occur at a completely unaware level and therefore, introduces the idea of an unconscious well-being. As such, the ability of having interests, is crucial for describing two abilities which those with comas are deficient in. Having an interest in a certain domain can be understood as having a stake in something that can affect what makes our life good in that domain. An interest is what directly and immediately improves life from a certain point of view or within a particular domain, or greatly increases the likelihood of life improvement enabling the subject to realize some good. That said, sensitivity to reward signals is a fundamental element in the learning process, both consciously and unconsciously.