User:Mr. Ibrahem/Darolutamide
Clinical data | |
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Trade names | Nubeqa |
Other names | Darramamide, ODM-201, BAY-1841788 |
AHFS/Drugs.com | Monograph |
MedlinePlus | a619045 |
License data |
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Pregnancy category |
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Routes of administration | By mouth |
Drug class | Nonsteroidal antiandrogen |
Legal status | |
Legal status | |
Pharmacokinetic data | |
Bioavailability | ≤30%[2] |
Protein binding | Darolutamide: 92%[2] Ketodarolutamide: 99.8%[2] |
Metabolism | Dehydrogenation (CYP3A4), glucuronidation (UGT1A9, UGT1A1)[2] |
Metabolites | Ketodarolutamide[2][4] |
Elimination half-life | 16–20 hours[2][4] |
Excretion | Urine: 63.4%[2] Feces: 32.4%[2] |
Identifiers | |
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Chemical and physical data | |
Formula | C19H19ClN6O2 |
Molar mass | 398.85 g·mol−1 |
3D model (JSmol) | |
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Darolutamide, sold under the brand name Nubeqa, is a medication used to treat prostate cancer.[2][3] Specifically it is used for non-metastatic castration-resistant prostate cancer (nmCRPC) together with surgical or medical castration.[2] The medication is taken by mouth twice per day with food.[2]
Common side effects include tiredness, pain in the arms and legs, and rash.[2] Other side effects may include infertility and low white blood cells.[6] Use during pregnancy by either the male or female may harm the baby.[2] It is a nonsteroidal antiandrogen (NSAA) and works by preventing androgens from binding to the androgen receptor.[6]
Darolutamide was patented in 2011.[7] It was approved for medical use in the United States in 2019 and Europe and Australia in 2020.[2][3][8] In the United Kingdom 4 weeks of medication costs the NHS about £4,000 as of 2021.[9] This amount in the United States is about 11,000 USD.[10]
References[edit]
- ^ "Nubeqa Australian prescription medicine decision summary". Therapeutic Goods Administration (TGA). 4 March 2020. Archived from the original on 28 August 2021. Retrieved 16 August 2020.
- ^ a b c d e f g h i j k l m n o p q "Nubeqa- darolutamide tablet, film coated". DailyMed. 31 July 2019. Archived from the original on 17 October 2020. Retrieved 22 November 2019.
- ^ a b c "Nubeqa EPAR". European Medicines Agency (EMA). 29 January 2020. Archived from the original on 29 October 2020. Retrieved 16 August 2020.
- ^ a b Fizazi K, Massard C, Bono P, Jones R, Kataja V, James N, et al. (August 2014). "Activity and safety of ODM-201 in patients with progressive metastatic castration-resistant prostate cancer (ARADES): an open-label phase 1 dose-escalation and randomised phase 2 dose expansion trial" (PDF). The Lancet. Oncology. 15 (9): 975–85. doi:10.1016/S1470-2045(14)70240-2. PMID 24974051. Archived (PDF) from the original on 1 December 2020. Retrieved 9 August 2021.
- ^ "Darolutamide (Nubeqa) Use During Pregnancy". Drugs.com. 17 September 2019. Archived from the original on 3 December 2020. Retrieved 16 August 2020.
- ^ a b "Darolutamide Monograph for Professionals". Drugs.com. Archived from the original on 23 November 2019. Retrieved 28 December 2021.
- ^ "Androgen receptor modulating compounds". Archived from the original on 3 September 2019. Retrieved 28 December 2021.
- ^ "AusPAR: Darolutamide". Therapeutic Goods Administration (TGA). 3 August 2020. Archived from the original on 21 September 2020. Retrieved 22 September 2020.
- ^ BNF 81: March-September 2021. BMJ Group and the Pharmaceutical Press. 2021. p. 991. ISBN 978-0857114105.
- ^ "Darolutamide Prices, Coupons & Savings Tips - GoodRx". GoodRx. Retrieved 28 December 2021.