Difference between revisions of "Darolutamide (Nubeqa)"

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For conciseness and simplicity, HemOnc.org currently will focus on treatment regimens and not list information such as: renal/hepatic dose adjustments, metabolism (including CYP450), excretion, monitoring parameters (although this will be considered for checklists), or manufacturer. Instead, for the most current information, please refer to your preferred pharmacopeias such as [http://www.thomsonhc.com/home/dispatch Micromedex], [http://online.lexi.com/ Lexicomp], [http://reference.medscape.com/drug/casodex-bicalutamide-342210 Medscape][http://www.utdol.com/online/content/search.do UpToDate (courtesy of Lexicomp)], or the prescribing information.
 
For conciseness and simplicity, HemOnc.org currently will focus on treatment regimens and not list information such as: renal/hepatic dose adjustments, metabolism (including CYP450), excretion, monitoring parameters (although this will be considered for checklists), or manufacturer. Instead, for the most current information, please refer to your preferred pharmacopeias such as [http://www.thomsonhc.com/home/dispatch Micromedex], [http://online.lexi.com/ Lexicomp], [http://reference.medscape.com/drug/casodex-bicalutamide-342210 Medscape][http://www.utdol.com/online/content/search.do UpToDate (courtesy of Lexicomp)], or the prescribing information.
  
==Preliminary data==
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==Diseases for which it is used==
===[[Prostate cancer]]===
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*[[Prostate cancer]]
# '''ARAMIS:''' Fizazi K, Shore N, Tammela TL, Ulys A, Vjaters E, Polyakov S, Jievaltas M, Luz M, Alekseev B, Kuss I, Kappeler C, Snapir A, Sarapohja T, Smith MR; ARAMIS Investigators. Darolutamide in nonmetastatic, castration-resistant prostate cancer. N Engl J Med. 2019 Mar 28;380(13):1235-1246. Epub 2019 Feb 14. [https://www.nejm.org/doi/full/10.1056/NEJMoa1815671 link to original article] [https://www.ncbi.nlm.nih.gov/pubmed/30763142 PubMed]
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==History of changes in FDA approval==
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*7/30/2019: Initial approval for non-metastatic castration-resistant [[prostate cancer]].
  
 
==Also known as==
 
==Also known as==
*'''Code name:''' BAY-1841788
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*'''Code name:''' BAY-1841788, ODM-201
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*'''Brand name:''' Nubeqa
  
 
==References==
 
==References==
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[[Category:Nonsteroidal antiandrogens]]
 
[[Category:Nonsteroidal antiandrogens]]
  
[[Category:Investigational drugs]]
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[[Category:Prostate cancer medications]]
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[[Category:FDA approved in 2019]]

Revision as of 17:01, 31 July 2019

General information

Class/mechanism: Antiandrogen; non-steroidal androgen receptor inhibitor, non-steroidal antiandrogen (NSAA) that competitively inhibits androgens by binding to androgen receptors and exhibiting antitumor activity by blocking testosterone-induced nuclear translocation of androgen receptors.[1]
Route: PO
Extravasation: n/a

For conciseness and simplicity, HemOnc.org currently will focus on treatment regimens and not list information such as: renal/hepatic dose adjustments, metabolism (including CYP450), excretion, monitoring parameters (although this will be considered for checklists), or manufacturer. Instead, for the most current information, please refer to your preferred pharmacopeias such as Micromedex, Lexicomp, MedscapeUpToDate (courtesy of Lexicomp), or the prescribing information.

Diseases for which it is used

History of changes in FDA approval

  • 7/30/2019: Initial approval for non-metastatic castration-resistant prostate cancer.

Also known as

  • Code name: BAY-1841788, ODM-201
  • Brand name: Nubeqa

References

  1. Moilanen AM, Riikonen R, Oksala R, Ravanti L, Aho E, Wohlfahrt G, Nykänen PS, Törmäkangas OP, Palvimo JJ, Kallio PJ. Discovery of ODM-201, a new-generation androgen receptor inhibitor targeting resistance mechanisms to androgen signaling-directed prostate cancer therapies. Sci Rep. 2015 Jul 3;5:12007. link to original article PubMed