Difference between revisions of "Relugolix (Orgovyx)"
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==General information== | ==General information== | ||
| − | Class/mechanism: Gonadotropin-releasing hormone (GnRH) receptor antagonist. Reversibly binds to pituitary GnRH receptors, reducing the release of luteinizing hormone (LH) and follicle stimulation hormone (FSH), resulting in rapid androgen deprivation/decreased testosterone levels. There is no initial testosterone surge/flare with relugolix, in contrast to GnRH agonists.<ref>[https://www.myovant.com/ | + | Class/mechanism: Gonadotropin-releasing hormone (GnRH) receptor antagonist. Reversibly binds to pituitary GnRH receptors, reducing the release of luteinizing hormone (LH) and follicle stimulation hormone (FSH), resulting in rapid androgen deprivation/decreased testosterone levels. There is no initial testosterone surge/flare with relugolix, in contrast to GnRH agonists.<ref>[https://www.orgovyx.com/ Relugolix manufacturer's website]</ref><ref name="insert">[https://www.myovant.com/wp-content/uploads/2020/12/NDA-214621-Final-USPIandPI.pdf Relugolix (Orgovyx) package insert]</ref><ref>[[:File:Relugolix.pdf|Relugolix (Orgovyx) package insert (locally hosted backup)]]</ref> |
<br>Route: PO | <br>Route: PO | ||
<br>Extravasation: n/a | <br>Extravasation: n/a | ||
| Line 8: | Line 8: | ||
==Diseases for which it is used== | ==Diseases for which it is used== | ||
*[[Prostate cancer]] | *[[Prostate cancer]] | ||
| + | |||
| + | ==Patient drug information== | ||
| + | *[https://www.myovant.com/wp-content/uploads/2020/12/NDA-214621-Final-USPIandPI.pdf Relugolix (Orgovyx) package insert]<ref name="insert"></ref> | ||
| + | *[http://www.uptodate.com/contents/relugolix-patient-drug-information Relugolix (Orgovyx) patient drug information (UpToDate)]<ref>[http://www.uptodate.com/contents/relugolix-patient-drug-information Relugolix (Orgovyx) patient drug information (UpToDate)]</ref> | ||
==History of changes in FDA indication== | ==History of changes in FDA indication== | ||
| − | *12 | + | *2020-12-18: Approved for adult patients with advanced [[prostate cancer]]. ''(Based on HERO)'' |
| − | + | ==History of changes in EMA indication== | |
| + | *2022-04-29: Initial authorization as Orgovyx. Orgovyx is indicated for the treatment of adult patients with advanced hormone-sensitive [[prostate cancer]]. ''(Based on HERO)'' | ||
| + | ==History of changes in PMDA indication== | ||
| + | *2019-01-08: Initial approval for the alleviation of menorrhagia, lower abdominal pain, backache, and anemia that are associated with uterine fibroids. | ||
==Also known as== | ==Also known as== | ||
*'''Code name:''' TAK-385 | *'''Code name:''' TAK-385 | ||
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[[Category:Prostate cancer medications]] | [[Category:Prostate cancer medications]] | ||
[[Category:FDA approved in 2020]] | [[Category:FDA approved in 2020]] | ||
| − | [[Category:PMDA approved | + | [[Category:EMA approved in 2022]] |
| + | [[Category:PMDA approved in 2019]] | ||
Latest revision as of 23:31, 16 September 2023
General information
Class/mechanism: Gonadotropin-releasing hormone (GnRH) receptor antagonist. Reversibly binds to pituitary GnRH receptors, reducing the release of luteinizing hormone (LH) and follicle stimulation hormone (FSH), resulting in rapid androgen deprivation/decreased testosterone levels. There is no initial testosterone surge/flare with relugolix, in contrast to GnRH agonists.[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
Patient drug information
History of changes in FDA indication
- 2020-12-18: Approved for adult patients with advanced prostate cancer. (Based on HERO)
History of changes in EMA indication
- 2022-04-29: Initial authorization as Orgovyx. Orgovyx is indicated for the treatment of adult patients with advanced hormone-sensitive prostate cancer. (Based on HERO)
History of changes in PMDA indication
- 2019-01-08: Initial approval for the alleviation of menorrhagia, lower abdominal pain, backache, and anemia that are associated with uterine fibroids.
Also known as
- Code name: TAK-385
- Brand names: Orgovyx, Relumina