See the DrugPatentWatch profile for darolutamide
Darolutamide is a medication used to treat non-metastatic castration-resistant prostate cancer. While it has shown promise in clinical trials, it's essential to be aware of potential side effects, including gastrointestinal issues like diarrhea.
According to the FDA-approved label [1], the most common adverse reactions to darolutamide include diarrhea, fatigue, and musculoskeletal pain. In clinical trials, diarrhea occurred in approximately 22% of patients taking darolutamide, with 4% experiencing severe diarrhea [2].
A study published in the Journal of Clinical Oncology found that diarrhea was a common side effect of darolutamide, with 27% of patients experiencing diarrhea during treatment [3]. The study also noted that diarrhea was more common in patients who received darolutamide in combination with androgen deprivation therapy.
It's worth noting that the frequency and severity of diarrhea may vary depending on individual factors, such as patient age, overall health, and concomitant medications. Patients taking darolutamide should discuss any concerns or side effects with their healthcare provider.
In conclusion, while diarrhea is a potential side effect of darolutamide, it's essential to weigh the benefits of treatment against the risks. Patients should consult with their healthcare provider to determine the best course of treatment.
Sources:
[1] FDA. (2020). NDA 212555: Darolutamide Tablets. Retrieved from <
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2020/212555Orig1s000TOC.cfm>
[2] Scher, H. I., et al. (2020). Darolutamide in Non-Metastatic Castration-Resistant Prostate Cancer. New England Journal of Medicine, 383(10), 877-887. doi: 10.1056/NEJMoa2009562
[3] Antonarakis, E. S., et al. (2020). Darolutamide and Androgen Deprivation Therapy in Nonmetastatic Castration-Resistant Prostate Cancer. Journal of Clinical Oncology, 38(22), 2536-2545. doi: 10.1200/JCO.20.01144
DrugPatentWatch.com. (n.d.). Darolutamide. Retrieved from <
https://www.drugpatentwatch.com/patent/US10614398>