Degarelix (Firmagon)

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 such as Micromedex, Lexicomp, UpToDate (courtesy of Lexicomp), or the prescribing information.^[1]

Diseases for which it is used

Prostate cancer

Patient drug information

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

References

[insert-1] 1.0 ^1.1 ^1.2 Degarelix (Firmagon) package insert

[2] Degarelix (Firmagon) package insert (locally hosted backup)

[3] Firmagon manufacturer's website

[4] Degarelix (Firmagon) patient drug information (Chemocare)

[5] Degarelix (Firmagon) patient drug information (UpToDate)

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