Degarelix

Degarelix is a GnRH receptor antagonist. It binds reversibly to the pituitary GnRH receptors, thereby reducing the release of gonadotropins and consequently testosterone.

• FIRMAGON ® is indicated for treatment of patients with advanced prostate cancer. FIRMAGON is a GnRH receptor antagonist indicated for treatment of patients with advanced prostate cancer.ICD-10: C61

• FIRMAGON is contraindicated in patients with history of severe hypersensitivity to degarelix or to any of the product components [see Warnings and Precautions (5.1) ] .contraindicated

FIRMAGON is for subcutaneous use only Starting Dosage: 240 mg given as two injections of 120 mg each ( 2.1 ) Maintenance Dosage: 80 mg administered as a single injection every 28 days ( 2.1 ) 2.1 Dosing information FIRMAGON is administered as a subcutaneous injection in the abdominal region only at the dosages in Table 1 below. Table 1: FIRMAGON Recommended Dosages Starting Dosage Maintenance Dosage – Administered once every 28 days 240 mg given as two subcutaneous injections of 120 mg at a concentration of 40 mg/mL The first maintenance dose should be given 28 days after the starting dose. 80 mg given as one subcutaneous injection at a concentration of 20 mg/mL 2.2 Reconstitution and Administration Instructions FIRMAGON is to be administered by a healthcare professional only . Before administering FIRMAGON read the Instructions for reconstitution and administration carefully. As with other drugs administered by subcutaneous injection, the injection site should vary periodically. Injections should be given only in areas of the abdomen that will not be exposed to pressure, e.g., not close to waistband or belt nor close to the ribs. FIRMAGON is supplied as a powder to be reconstituted with Sterile Water for Injection, USP. Starting dose (240 mg): Two single-dose vials each delivering 120 mg of degarelix in a white to off-white lyophilized powder for reconstitution supplied with diluent in two prefilled syringes. Each vial is to be reconstituted with a prefilled syringe containing 3 mL of Sterile Water for Injection.

Hypersensitivity: Anaphylaxis, urticaria and angioedema have been reported. Discontinue FIRMAGON if a severe hypersensitivity reaction occurs and manage as clinically indicated ( 5.1 ) QT Interval Prolongation: Androgen deprivation therapy treatment with FIRMAGON may prolong the QT interval. ( 5.2 ) Embryo-Fetal Toxicity: FIRMAGON can cause fetal harm. ( 5.4 , 8.1 ) 5.1 Hypersensitivity Reactions FIRMAGON is contraindicated in patients with history of severe hypersensitivity to degarelix or to any of the product components [see Contraindications (4) ]. Hypersensitivity reactions, including anaphylaxis, urticaria and angioedema, have been reported post-marketing with FIRMAGON. In case of a severe hypersensitivity reaction, discontinue FIRMAGON immediately if the injection has not been completed, and manage as clinically indicated. Patients with a known history of severe hypersensitivity reactions to FIRMAGON should not be re-challenged with FIRMAGON. 5.2 QT Interval Prolongation Androgen deprivation therapy may prolong the QT interval. Providers should consider whether the benefits of androgen deprivation therapy outweigh the potential risks in patients with congenital long QT syndrome, congestive heart failure, frequent electrolyte abnormalities, and in patients taking drugs known to prolong the QT interval. Electrolyte abnormalities should be corrected. Consider periodic monitoring of electrocardiograms and electrolytes. In the randomized, active-controlled trial comparing FIRMAGON to leuprolide, periodic electro-cardiograms were performed.

Most common adverse reactions (≥10%) are injection site reactions (e.g., pain, erythema, swelling or induration), hot flashes, and increases in serum levels of transaminases and gamma-glutamyltransferase (GGT) ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Ferring at 1-888-FERRING (1-888-337-7464) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. FIRMAGON was studied in a randomized, open-label trial in which patients with prostate cancer were randomized to receive FIRMAGON (subcutaneous) or leuprolide (intramuscular) monthly for 12 months [see Clinical Studies (14) ] . The most common adverse reactions (≥10%) during FIRMAGON therapy are injection site reactions (e.g., pain, erythema, swelling or induration), hot flashes, and increases in serum levels of transaminases and gamma-glutamyltransferase (GGT). The majority of the adverse reactions were Grade 1 or 2, with Grade 3/4 adverse reaction incidences of 1% or less. Adverse reactions reported in ≥ 5% of patients treated with FIRMAGON (subcutaneous) 240 mg starting dose and then 80 mg maintenance dose once every 28 days or who were treated with 7.5 mg of leuprolide (intramuscular) every 28 days are shown in Table 2.

Females and males of reproductive potential: FIRMAGON may impair fertility ( 8.3 ) Patients with severe liver or kidney dysfunction have not been studied and caution is therefore warranted ( 8 ) 8.1 Pregnancy Risk Summary The safety and efficacy of FIRMAGON have not been established in women. Based on findings in animal studies and mechanism of action, FIRMAGON can cause fetal harm and loss of pregnancy when administered to a pregnant woman [ see Clinical Pharmacology (12.1) ]. There are no human data on the use of FIRMAGON in pregnant women to inform the drug-associated risk. In animal developmental and reproductive toxicity studies in rats and rabbits, oral administration of degarelix during organogenesis caused embryo-fetal lethality and abortion as well as increased post-implantation loss and decreased the number of live fetuses in animals at doses less than the clinical loading dose based on body surface area ( see Data ). Advise pregnant patients and females of reproductive potential of the potential risk to the fetus. Data Animal Data When degarelix was given to rabbits during early organogenesis at doses of 0.002 mg/kg/day (about 0.02% of the clinical loading dose based on body surface area), there was an increase in early post-implantation loss.

Metabolism

Absorption FIRMAGON forms a depot upon subcutaneous administration, from which degarelix is released to the circulation. Following administration of FIRMAGON 240 mg at a product concentration of 40 mg/mL, the mean Cmax was 26.2 ng/mL (coefficient of variation, CV 83%) and the mean AUC was 1054 ng∙day/mL (CV 35%).

There have been no reports of overdose with FIRMAGON. In the case of overdose, however, discontinue FIRMAGON, treat the patient symptomatically, and institute supportive measures.

• Dec 24, 2008NDANDA022201Ferring

1. 1Fatigue3927.6%
2. 2Injection Site Pain3566.9%
3. 3Hot Flush3226.3%
4. 4Injection Site Erythema2915.7%
5. 5Asthenia2174.2%
6. 6Product Storage Error2094.1%
7. 7Injection Site Swelling2074.0%
8. 8Death1993.9%
9. 9Pyrexia1653.2%
10. 10Prostatic Specific Antigen Increased1643.2%
11. 11Fall1593.1%
12. 12Dizziness1492.9%
13. 13Nausea1462.8%
14. 14Pain1462.8%
15. 15Disease Progression1442.8%

The 10 most recently updated of 168 ClinicalTrials.gov registrations naming Degarelix as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

• Presurgical Phase II Study of Talazoparib in Combination With Enzalutamide in Prostate Cancer
  Recruiting · Phase 2 · Interventional · 30 enrolled · M.D. Anderson Cancer Center
  NCT05873192updated 2026-06-12
• NEPC Study: An Exploratory Safety and Efficacy Study With PSMA, SSTR2 and GRPR Targeted Radioligand Therapy in Metastatic Neuroendocrine Prostate Cancer.
  Active not recruiting · Phase 1 · Interventional · 31 enrolled · Novartis Pharmaceuticals
  NCT06379217updated 2026-06-10
• A Phase I/II Study of PDS01ADC With Docetaxel and Abiraterone in Adults With Metastatic Castration Sensitive and PDS01ADC With Docetaxel in Castration Resistant Prostate Cancer
  Recruiting · Phase 1 · Phase 2 · Interventional · 86 enrolled · National Cancer Institute (NCI)
  NCT04633252updated 2026-05-27
• Nivolumab + Docetaxel + ADT in mHSPC Patients With DDRD or Inflamed Tumors
  Active not recruiting · Phase 2 · Interventional · 47 enrolled · Xiao X. Wei, MD
  NCT04126070updated 2026-05-27
• Trial Comparing Irradiation Plus Long Term Adjuvant Androgen Deprivation With GnRH Antagonist Versus GnRH Agonist Plus Flare Protection in Patients With Very High Risk Localized or Locally Advanced Prostate Cancer
  Active not recruiting · Phase 3 · Interventional · 885 enrolled · European Organisation for Research and Treatment of Cancer - EORTC
  NCT02799706updated 2026-05-22
• Radiotherapy After Prostatectomy for Node Positive Prostate Cancer
  Active not recruiting · Phase 3 · Interventional · 372 enrolled · Sun Yat-sen University
  NCT07477626updated 2026-05-19
• Treating Prostate Cancer That Has Come Back After Surgery With Apalutamide and Targeted Radiation Based on PET Imaging
  Recruiting · Phase 3 · Interventional · 804 enrolled · ECOG-ACRIN Cancer Research Group
  NCT04423211updated 2026-05-15
• Assessing Efficacy of Neoadjuvant ADT in Localized High-Risk Prostate Cancer Patients Utilizing 18F-Flotufolastat PSMA PET/CT
  Recruiting · Phase 2 · Interventional · 50 enrolled · Baptist Health South Florida
  NCT07455903updated 2026-05-13
• Antiandrogen Therapy and Radiation Therapy With or Without Docetaxel in Treating Patients With Prostate Cancer That Has Been Removed by Surgery
  Completed · Phase 2 · Phase 3 · Interventional · 612 enrolled · NRG Oncology
  NCT03070886updated 2026-05-07
• Two Studies for Patients With Unfavorable Intermediate Risk Prostate Cancer Testing Less Intense Treatment for Patients With a Low Gene Risk Score and Testing a More Intense Treatment for Patients With a Higher Gene Risk Score, The Guidance Trial
  Active not recruiting · Phase 3 · Interventional · 2,050 enrolled · NRG Oncology
  NCT05050084updated 2026-05-04

Frequently asked questions

How does Degarelix work?

Degarelix is a GnRH receptor antagonist. It binds reversibly to the pituitary GnRH receptors, thereby reducing the release of gonadotropins and consequently testosterone.

What is Degarelix used for?

According to FDA labeling, Degarelix carries indications including: FIRMAGON ® is indicated for treatment of patients with advanced prostate cancer. FIRMAGON is a GnRH receptor antagonist indicated for treatment of patients with advanced prostate cancer.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.

What class of drug is Degarelix?

Degarelix is classified as Other hormone antagonists and related agents, Gonadotropin Releasing Hormone Receptor Antagonist, Gonadotropin Releasing Hormone Receptor Antagonists, Decreased GnRH Secretion, Decreased Testosterone Secretion.

What are the brand names for Degarelix?

Degarelix is marketed under brand names including Firmagon.

What are the contraindications for Degarelix?

Degarelix labeling lists contraindications including: FIRMAGON is contraindicated in patients with history of severe hypersensitivity to degarelix or to any of the product components [see Warnings and Precautions (5.1) ] .. Always consult the full prescribing information and a clinician.