Degarelix dosage in published studies and labels
These are the doses used for Degarelix in FDA labelling and published clinical studies, reported as each source states them, one row per regimen. They describe what was studied or approved for a specific population. They are not a recommendation, and none of them is a dose for any individual.
Research and educational reference only. This is not medical advice, and no figure on this page is a dosing recommendation.
Last checked against primary sources:
Studied regimens and sources
Degarelix has an FDA-approved human dosage for advanced prostate cancer. The FIRMAGON label gives a 240 mg starting dose as two 120 mg injections under the skin of the abdomen, then 80 mg as one injection every 28 days, starting 28 days after the first dose.
| Human dosing established | Yes |
|---|---|
| Route | Subcutaneous |
| Frequency | Starting dose once, then every 28 days |
| Duration studied | Long-term |
| Evidence level | FDA Approved |
| Last reviewed | 2026-11-07 |
Research-reported dosing
Doses as studied, one row per regimen. Different trials used different regimens; they are listed separately rather than averaged.
| Study / context | Population | Dose | Route | Frequency | Duration | Outcome studied | Source |
|---|---|---|---|---|---|---|---|
| FDA label — FIRMAGON, advanced prostate cancerFDA-approved label · FDA prescribing information | Patients with advanced prostate cancer | Starting dose 240 mg as two 120 mg injections (40 mg/mL); maintenance 80 mg as one injection (20 mg/mL) | Subcutaneous, abdomen only | Maintenance every 28 days, the first 28 days after the starting dose | Long-term | Treatment of advanced prostate cancer | FIRMAGON (degarelix for injection) — FDA prescribing information (Ferring), DailyMed |
| CS21 — phase 3 trial against leuprolide (Klotz et al., 2008)Clinical trial · Phase 3 randomised open-label trial | Men with prostate adenocarcinoma needing androgen deprivation (n=610) | 240 mg start, then 80 mg or 160 mg monthly; comparator leuprolide 7.5 mg intramuscularly monthly | Subcutaneous | Monthly | 12 months | Testosterone at or below 0.5 ng/mL from day 28 to day 364 in 97.2% (240/80 mg), 98.3% (240/160 mg) and 96.4% (leuprolide); injection-site reactions 40% with degarelix against under 1% with leuprolide | Klotz L et al. The efficacy and safety of degarelix: a 12-month, comparative, randomized, open-label, parallel-group phase III study in patients with prostate cancer. BJU Int. 2008. |
Where sources disagree
- The starting and maintenance doses use different concentrations (40 mg/mL and 20 mg/mL). The label says FIRMAGON is given by a healthcare professional only.
- The label warns of hypersensitivity reactions including anaphylaxis, QT interval prolongation with androgen deprivation therapy, and embryo-fetal toxicity.
- In the CS21 trial testosterone was at or below 0.5 ng/mL 3 days after the first dose in about 96% of men on degarelix and in none on leuprolide. FIRMAGON is labelled as a GnRH receptor antagonist; leuprolide, the comparator, is a GnRH agonist.