degarelix
Firmagon · ATC code L02BX02
Also known as: Degareliks
- Key facts
- Active substance
- degarelix
- ATC code
- L02BX02
- Authorisation
- centrally authorised across the EU (EMA)
- Dosage forms
- FIRMAGON 80 mg powder and solvent for solution for injection / FIRMAGON 120 mg powder and solvent for solution for injection
- Marketing authorisation holder
- Ferring Pharmaceuticals A/S
- Information as of
- 2026-10-29
Key facts
Degarelix is a gonadotrophin releasing hormone (GnRH) antagonist that rapidly lowers testosterone. It is used in men with hormone-dependent prostate cancer.
What it is used for
- Adult men with advanced hormone-dependent prostate cancer.
- High-risk localised and locally advanced hormone-dependent prostate cancer in combination with radiotherapy.
- Neo-adjuvant treatment prior to radiotherapy in high-risk localised or locally advanced hormone-dependent prostate cancer.
Dosing
- Firmagon, starting dose: 240 mg given as two consecutive subcutaneous injections of 120 mg each.
- Firmagon, maintenance dose: 80 mg as one subcutaneous injection monthly; the first maintenance dose is given one month after the starting dose.
- Subcutaneous use in the abdominal region only, not intravenous; vary the injection site and avoid pressure areas (waistband, ribs).
- No adjustment for the elderly or in mild or moderate liver or kidney impairment; severe impairment not studied, caution warranted.
- Because there is no testosterone surge, adding an anti-androgen as surge protection at initiation is not necessary.
Contraindications
- Hypersensitivity to the active substance or to any of the excipients.
Important warnings
- Long-term androgen deprivation therapy may prolong the QT interval; with a history of QTc prolongation, risk factors for torsades de pointes or QT-prolonging medicines, the benefit/risk must be thoroughly appraised.
- Mild, transient ALT and AST increases; monitor liver function in known or suspected hepatic disorder.
- Long periods of testosterone suppression can be anticipated to affect bone density.
- Reduced glucose tolerance may occur; diabetic patients may need more frequent blood glucose monitoring.
- Cardiovascular disease such as stroke and myocardial infarction has been reported with androgen deprivation; consider cardiovascular risk factors.
Side effects
- Most common: hot flushes (25%) and weight increase (7%), and injection site reactions, mainly pain (28%) and erythema (17%).
- Transient chills, fever or influenza-like illness hours after dosing.
- Very rarely serious injection site reactions (infection, abscess, necrosis).
Interactions
- Medicines that prolong the QTc interval or can induce torsades de pointes (e.g. quinidine, amiodarone, sotalol, methadone, moxifloxacin, antipsychotics): evaluate the combination carefully.
- Clinically significant pharmacokinetic interactions via CYP450 are unlikely.
Pregnancy and breastfeeding
- No relevant use in women. May inhibit male fertility as long as testosterone is suppressed.
Summary of the official product information, written with AI on 2026-10-29. Every number was checked automatically against the original text. Not reviewed by a physician – the full official text is authoritative.
Common questions – ask Medelix
For patients
Package leaflet, verbatim
This product has no separate US patient information.
Authorisation and brand names by country
Medicines with exactly this active-substance composition, as listed in the national registers – alphabetical and without ranking. Whether a product is currently available is not shown here.
EU – centrally authorised (all member states)
- Degarelix Accord · genericAccord Healthcare S.L.U. · EMEA/H/C/006048
- FirmagonFerring Pharmaceuticals A/S · EMEA/H/C/000986
Source: European Medicines Agency (EMA), product information
Brand names in 3 more European countries
- Iceland
- Degarelix Accord, Firmagon
- Liechtenstein
- Degarelix Accord, Firmagon
- Norway
- Degarelix Accord, Firmagon
EMA – Article 57 product data (EU/EEA), 2026-10-29
Medelix receives no money from pharmaceutical companies. Brand names are listed alphabetically and without ranking.
Other substances in the same group
Another question about this substance?
Medelix answers clinical questions from guidelines, studies and product information – every claim with its source.
Sources
- European Medicines Agency. Firmagon – EPAR, Product Information. 2026-10-29. https://www.ema.europa.eu/en/documents/product-information/firmagon-epar-product-information_en.pdf
Editorial: Medelix editorial team · last updated 2026-10-29 · How these pages are made · Report an error
Source: European Medicines Agency (EMA), product information. Not advertising, not a treatment recommendation. For questions about your own treatment, ask your doctor or pharmacist.