Difference between revisions of "Degarelix (Firmagon)"
Jump to navigation
Jump to search
Warner-admin (talk | contribs) m (Text replacement - "Category:Drug index" to "Category:Drugs") |
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") |
||
| (18 intermediate revisions by 4 users not shown) | |||
| Line 1: | Line 1: | ||
==General information== | ==General information== | ||
| − | Class/mechanism: Gonadotropin-releasing hormone (GnRH) receptor antagonist. | + | 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 degarelix, in contrast to GnRH agonists.<ref name="insert">[http://www.ferringusa.com/pi/firmagon Degarelix (Firmagon) package insert]</ref><ref>[[:File:Degarelix.pdf | Degarelix (Firmagon) package insert (locally hosted backup)]]</ref><ref>[https://firmagon.com/ Firmagon manufacturer's website]</ref> |
<br>Route: SC | <br>Route: SC | ||
<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== | ||
| Line 11: | Line 11: | ||
==Patient drug information== | ==Patient drug information== | ||
*[http://www.ferringusa.com/pi/firmagon Degarelix (Firmagon) package insert]<ref name="insert"></ref> | *[http://www.ferringusa.com/pi/firmagon Degarelix (Firmagon) package insert]<ref name="insert"></ref> | ||
| + | *[https://chemocare.com/druginfo/degarelix.aspx Degarelix (Firmagon) patient drug information (Chemocare)]<ref>[https://chemocare.com/druginfo/degarelix.aspx Degarelix (Firmagon) patient drug information (Chemocare)]</ref> | ||
*[http://www.uptodate.com/contents/degarelix-patient-drug-information Degarelix (Firmagon) patient drug information (UpToDate)]<ref>[http://www.uptodate.com/contents/degarelix-patient-drug-information Degarelix (Firmagon) patient drug information (UpToDate)]</ref> | *[http://www.uptodate.com/contents/degarelix-patient-drug-information Degarelix (Firmagon) patient drug information (UpToDate)]<ref>[http://www.uptodate.com/contents/degarelix-patient-drug-information Degarelix (Firmagon) patient drug information (UpToDate)]</ref> | ||
==History of changes in FDA indication== | ==History of changes in FDA indication== | ||
| − | *12 | + | *2008-12-24: [http://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDER/ucm129207.htm Approved] for treatment of patients with advanced [[prostate cancer]]. ''(Based on CS21)'' |
| − | + | ==History of changes in EMA indication== | |
| + | *2009-02-17: Initial authorization as Firmagon. Firmagon is a gonadotrophin releasing hormone (GnRH) antagonist indicated for treatment of adult male patients with advanced hormone-dependent [[prostate cancer]]. | ||
| + | *2021-10-19: Extension of indication to include treatment of high-risk localized and locally advanced hormone dependent [[prostate cancer]] in combination with radiotherapy. | ||
| + | *2021-10-19: Extension of indication to include treatment as neo-adjuvant prior to radiotherapy in patients with high-risk localised or locally advanced hormone dependent [[prostate cancer]]. | ||
| + | ==History of changes in Health Canada indication== | ||
| + | *2009-11-16: Initial notice of compliance for testosterone suppression in patients with advanced hormone-dependent [[prostate cancer]] in whom androgen deprivation is warranted. | ||
| + | ==History of changes in PMDA indication== | ||
| + | *2012-06-29: Initial approval for the treatment of [[prostate cancer]]. | ||
==Also known as== | ==Also known as== | ||
| − | *'''Code name:''' | + | *'''Code name:''' ASP-3550, FE-200486 |
*'''Generic name:''' degarelix acetate | *'''Generic name:''' degarelix acetate | ||
| − | *'''Brand name:''' Firmagon | + | *'''Brand name:''' Firmagon, Gonax |
==References== | ==References== | ||
| Line 26: | Line 34: | ||
[[Category:Drugs]] | [[Category:Drugs]] | ||
[[Category:Subcutaneous medications]] | [[Category:Subcutaneous medications]] | ||
| − | + | ||
[[Category:GnRH antagonists]] | [[Category:GnRH antagonists]] | ||
[[Category:Prostate cancer medications]] | [[Category:Prostate cancer medications]] | ||
| − | [[Category: | + | [[Category:FDA approved in 2008]] |
| + | [[Category:EMA approved in 2009]] | ||
| + | [[Category:Health Canada approved in 2009]] | ||
| + | [[Category:PMDA approved in 2012]] | ||
Latest revision as of 01:03, 29 June 2024
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 degarelix, in contrast to GnRH agonists.[1][2][3]
Route: SC
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
- Degarelix (Firmagon) package insert[1]
- Degarelix (Firmagon) patient drug information (Chemocare)[4]
- Degarelix (Firmagon) patient drug information (UpToDate)[5]
History of changes in FDA indication
- 2008-12-24: Approved for treatment of patients with advanced prostate cancer. (Based on CS21)
History of changes in EMA indication
- 2009-02-17: Initial authorization as Firmagon. Firmagon is a gonadotrophin releasing hormone (GnRH) antagonist indicated for treatment of adult male patients with advanced hormone-dependent prostate cancer.
- 2021-10-19: Extension of indication to include treatment of high-risk localized and locally advanced hormone dependent prostate cancer in combination with radiotherapy.
- 2021-10-19: Extension of indication to include treatment as neo-adjuvant prior to radiotherapy in patients with high-risk localised or locally advanced hormone dependent prostate cancer.
History of changes in Health Canada indication
- 2009-11-16: Initial notice of compliance for testosterone suppression in patients with advanced hormone-dependent prostate cancer in whom androgen deprivation is warranted.
History of changes in PMDA indication
- 2012-06-29: Initial approval for the treatment of prostate cancer.
Also known as
- Code name: ASP-3550, FE-200486
- Generic name: degarelix acetate
- Brand name: Firmagon, Gonax