Difference between revisions of "Relugolix (Orgovyx)"
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==History of changes in EMA indication== | ==History of changes in EMA indication== | ||
*2022-04-29: Initial authorization | *2022-04-29: Initial authorization | ||
| + | ==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:FDA approved in 2020]] | [[Category:FDA approved in 2020]] | ||
[[Category:EMA approved in 2022]] | [[Category:EMA approved in 2022]] | ||
| − | [[Category:PMDA approved | + | [[Category:PMDA approved in 2019]] |
Revision as of 01:28, 11 June 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
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