Difference between revisions of "Enzalutamide (Xtandi)"
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m (PeterYang moved page Enzalutamide (MDV3100) to Enzalutamide (Xtandi): FDA approval) |
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| − | ''' | + | '''FDA approved 8/31/2012.''' Also known as MDV3100. |
==General information== | ==General information== | ||
| − | Class/mechanism: Antiandrogen | + | Class/mechanism: Antiandrogen; androgen receptor inhibitor (ARI) or androgen receptor signaling inhibitor (ARSI). Enzalutamide competitively inhibits testosterone from binding to the androgen receptor, interferes with translocation of the androgen receptor to the nucleus, and inhibits binding to DNA, resulting in decreased prostate cancer proliferation and cell death.<ref name="insert">[http://www.astellas.us/docs/us/12A005-ENZ-WPI.pdf Enzalutamide (Xtandi) package insert]</ref><ref>[[Media:Enzalutamide.pdf | Enzalutamide (Xtandi) package insert (locally hosted backup)]]</ref><ref>[http://www.medivation.com/product-pipeline/enzalutamide Enzalutamide (MDV3100) manufacturer's website]</ref> |
<br>Route: PO | <br>Route: PO | ||
<br>Extravasation: n/a | <br>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 [http://www.thomsonhc.com/home/dispatch Micromedex], [http://online.lexi.com/ Lexicomp], [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://www.utdol.com/online/content/search.do UpToDate (courtesy of Lexicomp)], or the prescribing information. | ||
| + | |||
| + | ==Diseases for which it is used== | ||
| + | *[[Prostate cancer]] | ||
==Clinical trials== | ==Clinical trials== | ||
| − | *AFFIRM: [http:// | + | *AFFIRM: [http://www.ncbi.nlm.nih.gov/pubmed/22894553 Safety and Efficacy Study of MDV3100 in Patients With Castration-Resistant Prostate Cancer Who Have Been Previously Treated With Docetaxel-based Chemotherapy (AFFIRM)]<ref>Scher HI, Fizazi K, Saad F, Taplin ME, Sternberg CN, Miller MD, de Wit R, Mulders P, Chi KN, Shore ND, Armstrong AJ, Flaig TW, Fléchon A, Mainwaring P, Fleming M, Hainsworth JD, Hirmand M, Selby B, Seely L, de Bono JS; the AFFIRM Investigators. Increased Survival with Enzalutamide in Prostate Cancer after Chemotherapy. N Engl J Med. 2012 Aug 15. [Epub ahead of print] [http://www.nejm.org/doi/full/10.1056/NEJMoa1207506 link to original article] '''contains verified protocol''' [http://www.ncbi.nlm.nih.gov/pubmed/22894553 PubMed] [http://clinicaltrials.gov/ct2/show/NCT00974311 ClinicalTrials.gov]</ref> |
*PREVAIL: [http://clinicaltrials.gov/ct2/show/NCT01212991 A Safety and Efficacy Study of Oral MDV3100 in Chemotherapy-Naive Patients With Progressive Metastatic Prostate Cancer (PREVAIL)] | *PREVAIL: [http://clinicaltrials.gov/ct2/show/NCT01212991 A Safety and Efficacy Study of Oral MDV3100 in Chemotherapy-Naive Patients With Progressive Metastatic Prostate Cancer (PREVAIL)] | ||
==Patient drug information== | ==Patient drug information== | ||
| − | + | *[http://www.astellas.us/docs/us/12A005-ENZ-WPI.pdf Enzalutamide (Xtandi) package insert PDF pages 14-16]<ref name="insert"></ref> | |
==References== | ==References== | ||
<references/> | <references/> | ||
Revision as of 01:18, 1 September 2012
FDA approved 8/31/2012. Also known as MDV3100.
General information
Class/mechanism: Antiandrogen; androgen receptor inhibitor (ARI) or androgen receptor signaling inhibitor (ARSI). Enzalutamide competitively inhibits testosterone from binding to the androgen receptor, interferes with translocation of the androgen receptor to the nucleus, and inhibits binding to DNA, resulting in decreased prostate cancer proliferation and cell death.[1][2][3]
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, UpToDate (courtesy of Lexicomp), or the prescribing information.
Diseases for which it is used
Clinical trials
- AFFIRM: Safety and Efficacy Study of MDV3100 in Patients With Castration-Resistant Prostate Cancer Who Have Been Previously Treated With Docetaxel-based Chemotherapy (AFFIRM)[4]
- PREVAIL: A Safety and Efficacy Study of Oral MDV3100 in Chemotherapy-Naive Patients With Progressive Metastatic Prostate Cancer (PREVAIL)
Patient drug information
References
- ↑ 1.0 1.1 Enzalutamide (Xtandi) package insert
- ↑ Enzalutamide (Xtandi) package insert (locally hosted backup)
- ↑ Enzalutamide (MDV3100) manufacturer's website
- ↑ Scher HI, Fizazi K, Saad F, Taplin ME, Sternberg CN, Miller MD, de Wit R, Mulders P, Chi KN, Shore ND, Armstrong AJ, Flaig TW, Fléchon A, Mainwaring P, Fleming M, Hainsworth JD, Hirmand M, Selby B, Seely L, de Bono JS; the AFFIRM Investigators. Increased Survival with Enzalutamide in Prostate Cancer after Chemotherapy. N Engl J Med. 2012 Aug 15. [Epub ahead of print] link to original article contains verified protocol PubMed ClinicalTrials.gov