Difference between revisions of "Apalutamide (Erleada)"
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Warner-admin (talk | contribs) m (Text replacement - "please refer to your preferred pharmacopeias such as [http://www.thomsonhc.com/home/dispatch Micromedex], [https://online.lexi.com/lco/action/login UpToDate Lexidrug], [http://www.utdol.com/online/content/search.do UpToDate (courtesy of Lexicomp)], or the prescribing information" to "please refer to your preferred pharmacopeias or the prescribing information") |
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==General information== | ==General information== | ||
Class/mechanism: Antiandrogen; androgen receptor inhibitor (ARI). Apalutamide competitively inhibits activity mediated by the androgen receptor (AR) by binding directly to the AR ligand-binding domain, nuclear translocation, DNA binding, and AR-mediated transcription. A metabolite of apalutamide, | Class/mechanism: Antiandrogen; androgen receptor inhibitor (ARI). Apalutamide competitively inhibits activity mediated by the androgen receptor (AR) by binding directly to the AR ligand-binding domain, nuclear translocation, DNA binding, and AR-mediated transcription. A metabolite of apalutamide, | ||
| − | N-desmethyl apalutamide, also exhibits some AR inhibiting activity, about 1/3 that of apalutamide.<ref name="insert">[http://www.janssenlabels.com/package-insert/product-monograph/prescribing-information/ERLEADA-pi.pdf Apalutamide (Erleada) package insert]</ref><ref>[[ | + | N-desmethyl apalutamide, also exhibits some AR inhibiting activity, about 1/3 that of apalutamide.<ref name="insert">[http://www.janssenlabels.com/package-insert/product-monograph/prescribing-information/ERLEADA-pi.pdf Apalutamide (Erleada) package insert]</ref><ref>[[:File:Apalutamide.pdf | Apalutamide (Erleada) package insert (locally hosted backup)]]</ref><ref>[https://www.erleadahcp.com Erleada 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 | + | 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 or the prescribing information.<ref name="insert"></ref> |
==Diseases for which it is used== | ==Diseases for which it is used== | ||
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==Patient drug information== | ==Patient drug information== | ||
*[http://www.janssenlabels.com/package-insert/product-monograph/prescribing-information/ERLEADA-pi.pdf Apalutamide (Erleada) package insert]<ref name="insert"></ref> | *[http://www.janssenlabels.com/package-insert/product-monograph/prescribing-information/ERLEADA-pi.pdf Apalutamide (Erleada) package insert]<ref name="insert"></ref> | ||
| − | *[https://chemocare.com/ | + | *[https://chemocare.com/druginfo/apalutamide.aspx Apalutamide (Erleada) patient drug information (Chemocare)]<ref>[https://chemocare.com/druginfo/apalutamide.aspx Apalutamide (Erleada) patient drug information (Chemocare)]</ref> |
*[http://www.uptodate.com/contents/apalutamide-patient-drug-information Apalutamide (Erleada) patient drug information (UpToDate)]<ref>[http://www.uptodate.com/contents/apalutamide-patient-drug-information Apalutamide (Erleada) patient drug information (UpToDate)]</ref> | *[http://www.uptodate.com/contents/apalutamide-patient-drug-information Apalutamide (Erleada) patient drug information (UpToDate)]<ref>[http://www.uptodate.com/contents/apalutamide-patient-drug-information Apalutamide (Erleada) patient drug information (UpToDate)]</ref> | ||
==History of changes in FDA indication== | ==History of changes in FDA indication== | ||
| − | * | + | *2018-02-14: [https://www.fda.gov/newsevents/newsroom/pressannouncements/ucm596768.htm FDA approved] for patients with non-metastatic castration-resistant [[prostate cancer]] (NM-CRPC). ''(Based on SPARTAN)'' |
| − | * | + | *2019-09-17: Approved for patients with metastatic castration-sensitive [[prostate cancer]] (mCSPC). ''(Based on TITAN<sub>prostate</sub>)'' |
| + | ==History of changes in EMA indication== | ||
| + | *2019-01-14: Initial marketing authorization as Erleada. Erleada is indicated in adult men for the treatment of non-metastatic castration resistant [[prostate cancer]] (NM CRPC) who are at high risk of developing metastatic disease. ''(Based on SPARTAN)'' | ||
| + | *2020-01-27: Extension of Indication to include the treatment of metastatic hormone-sensitive [[prostate cancer]] (mHSPC) in combination with androgen deprivation therapy (ADT). ''(Based on TITAN<sub>prostate</sub>)'' | ||
| + | |||
| + | ==History of changes in Health Canada indication== | ||
| + | *2018-07-03: Initial notice of compliance for the treatment of patients with non-metastatic castration-resistant [[prostate cancer]] at high risk of developing metastases. | ||
| + | *2019-12-12: New indication | ||
| + | ==History of changes in PMDA indication== | ||
| + | *2019-03-26: New approval for the treatment of non-metastatic, castration-resistant [[prostate cancer]]. | ||
| + | *2020-05-29: New indication for the treatment of metastatic [[prostate cancer]]. | ||
==Also known as== | ==Also known as== | ||
*'''Code name:''' ARN-509 | *'''Code name:''' ARN-509 | ||
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[[Category:Oral medications]] | [[Category:Oral medications]] | ||
| − | [[Category: | + | [[Category:Second-generation nonsteroidal antiandrogens]] |
[[Category:Prostate cancer medications]] | [[Category:Prostate cancer medications]] | ||
| + | [[Category:EMA approved in 2019]] | ||
[[Category:FDA approved in 2018]] | [[Category:FDA approved in 2018]] | ||
| + | [[Category:Health Canada approved in 2018]] | ||
| + | [[Category:PMDA approved in 2019]] | ||
Latest revision as of 01:00, 29 June 2024
General information
Class/mechanism: Antiandrogen; androgen receptor inhibitor (ARI). Apalutamide competitively inhibits activity mediated by the androgen receptor (AR) by binding directly to the AR ligand-binding domain, nuclear translocation, DNA binding, and AR-mediated transcription. A metabolite of apalutamide,
N-desmethyl apalutamide, also exhibits some AR inhibiting activity, about 1/3 that of apalutamide.[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 or the prescribing information.[1]
Diseases for which it is used
Patient drug information
- Apalutamide (Erleada) package insert[1]
- Apalutamide (Erleada) patient drug information (Chemocare)[4]
- Apalutamide (Erleada) patient drug information (UpToDate)[5]
History of changes in FDA indication
- 2018-02-14: FDA approved for patients with non-metastatic castration-resistant prostate cancer (NM-CRPC). (Based on SPARTAN)
- 2019-09-17: Approved for patients with metastatic castration-sensitive prostate cancer (mCSPC). (Based on TITANprostate)
History of changes in EMA indication
- 2019-01-14: Initial marketing authorization as Erleada. Erleada is indicated in adult men for the treatment of non-metastatic castration resistant prostate cancer (NM CRPC) who are at high risk of developing metastatic disease. (Based on SPARTAN)
- 2020-01-27: Extension of Indication to include the treatment of metastatic hormone-sensitive prostate cancer (mHSPC) in combination with androgen deprivation therapy (ADT). (Based on TITANprostate)
History of changes in Health Canada indication
- 2018-07-03: Initial notice of compliance for the treatment of patients with non-metastatic castration-resistant prostate cancer at high risk of developing metastases.
- 2019-12-12: New indication
History of changes in PMDA indication
- 2019-03-26: New approval for the treatment of non-metastatic, castration-resistant prostate cancer.
- 2020-05-29: New indication for the treatment of metastatic prostate cancer.
Also known as
- Code name: ARN-509
- Brand name: Erleada