Firmagon

degarelix

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This is a summary of the European public assessment report (EPAR). It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the studies performed, to reach its recommendations on how to use the medicine.

If you need more information about your medical condition or your treatment, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. If you want more information on the basis of the CHMP recommendations, read the scientific discussion (also part of the EPAR).

What is Firmagon?

Firmagon is a powder and solvent that are made up into a solution for injection. It contains the active substance degarelix.

What is Firmagon used for?

Firmagon is used to treat patients with advanced prostate cancer. This is cancer that affects the prostate gland, the gland below the bladder in men that produces the liquid in the semen. ‘Advanced’ means that the cancer has spread beyond the gland to some lymph nodes, but not to other organs. Firmagon can be used if the cancer is ‘hormone-dependent’, which means that it responds to treatments that reduce the levels of the hormone testosterone.

The medicine can only be obtained with a prescription.

How is Firmagon used?

Firmagon is injected under the skin of the abdomen. Treatment starts with two 120-mg injections, followed by single 80-mg injections every month. Firmagon must not be injected into a vein or a muscle. Doctors should monitor the effectiveness of Firmagon treatment by looking at blood levels of testosterone and prostate-specific antigen (PSA). PSA is a protein that is produced by the prostate gland and is often found at high levels in men with prostate cancer.

Firmagon should be used with caution in patients who have severe kidney or liver problems.

How does Firmagon work?

Testosterone can make prostate cancer cells grow. The active substance in Firmagon, degarelix, is a gonadotrophin-releasing-hormone antagonist, which means that it blocks the effects of a natural hormone called gonadotrophin-releasing hormone (GnRH). GnRH normally stimulates the pituitary gland at the base of the brain to produce two hormones which cause the testes to produce testosterone. By blocking these processes, Firmagon reduces the amount of testosterone in the body and slows down the growth of the cancer cells. When injected, Firmagon forms a gel under the skin that releases the active substance slowly over a few weeks.

How has Firmagon been studied?

The effects of Firmagon were first tested in experimental models before being studied in humans.

Two doses of Firmagon have been compared with leuprorelin in one main study involving 610 men with prostate cancer at all stages of the disease. The main measure of effectiveness was the number of patients whose testosterone levels were below those seen in men whose testes were producing no testosterone, over the first year of treatment.

What benefit has Firmagon shown during the studies?

Firmagon was as effective as leuprorelin at reducing testosterone levels. During the first year, 97% of the patients receiving Firmagon at the approved dose of 80 mg once a month dose had testosterone levels below the required level. This was compared with 96% of patients receiving leuprorelin. Similar results were seen in patients receiving Firmagon at the higher dose of 160 mg once a month.

What is the risk associated with Firmagon?

The most common side effects with Firmagon (seen in more than 1 patient in 10) are hot flushes and problems at the injection site such as pain and redness. For the full list of all side effects reported with Firmagon, see the package leaflet.

Firmagon should not be used in people who may be hypersensitive (allergic) to degarelix or any of the other ingredients.

Why has Firmagon been approved?

The Committee for Medicinal Products for Human Use (CHMP) noted that Firmagon was as effective as leuprorelin in the main study. However, because the main study looked at the medicine’s effects on testosterone levels rather than the cancer or the patient’s outcome directly, and because leuprorelin is only used for prostate cancer that is advanced, the Committee decided to restrict the use of Firmagon to advanced prostate cancer.

The Committee also noted that treatment with Firmagon does not trigger the temporary sharp rise in testosterone levels seen with ‘GnRH agonists’ (other medicines for prostate cancer that stimulate the production of GnRH). This means that patients do not need to take other medicines to block testosterone at the start of treatment.

Therefore, the CHMP decided that Firmagon’s benefits are greater than its risks for the treatment of adult male patients with advanced hormone-dependent prostate cancer. The Committee recommended that Firmagon be given marketing authorisation.

Which measures are being taken to ensure the safe use of Firmagon?

The company that makes Firmagon will make sure that educational materials are provided to all doctors in all Member States who will prescribe the medicine. The materials will include information on Firmagon’s safety and remind doctors how to administer the medicine.

Other information about Firmagon

The European Commission granted a marketing authorisation valid throughout the European Union for Firmagon to Ferring Pharmaceuticals A/S on 17 February 2009.

Name Language First published Last updated
Firmagon : EPAR - Summary for the public BG = bălgarski 2009-03-04  
Firmagon : EPAR - Summary for the public ES = español 2009-03-04  
Firmagon : EPAR - Summary for the public CS = čeština 2009-03-04  
Firmagon : EPAR - Summary for the public DA = dansk 2009-03-04  
Firmagon : EPAR - Summary for the public DE = Deutsch 2009-03-04  
Firmagon : EPAR - Summary for the public ET = eesti keel 2009-03-04  
Firmagon : EPAR - Summary for the public EL = elliniká 2009-03-04  
Firmagon : EPAR - Summary for the public EN = English 2009-03-04  
Firmagon : EPAR - Summary for the public FR = français 2009-03-04  
Firmagon : EPAR - Summary for the public IT = italiano 2009-03-04  
Firmagon : EPAR - Summary for the public LV = latviešu valoda 2009-03-04  
Firmagon : EPAR - Summary for the public LT = lietuvių kalba 2009-03-04  
Firmagon : EPAR - Summary for the public HU = magyar 2009-03-04  
Firmagon : EPAR - Summary for the public MT = Malti 2009-03-04  
Firmagon : EPAR - Summary for the public NL = Nederlands 2009-03-04  
Firmagon : EPAR - Summary for the public PL = polski 2009-03-04  
Firmagon : EPAR - Summary for the public PT = português 2009-03-04  
Firmagon : EPAR - Summary for the public RO = română 2009-03-04  
Firmagon : EPAR - Summary for the public SK = slovenčina 2009-03-04  
Firmagon : EPAR - Summary for the public SL = slovenščina 2009-03-04  
Firmagon : EPAR - Summary for the public FI = suomi 2009-03-04  
Firmagon : EPAR - Summary for the public SV = svenska 2009-03-04  

This EPAR was last updated on 22/01/2015 .

Authorisation details

Product details

Product details for Firmagon
NameFirmagon
Agency product numberEMEA/H/C/000986
Active substance

degarelix

International non-proprietary name (INN) or common name

degarelix

Therapeutic area Prostatic Neoplasms
Anatomical therapeutic chemical (ATC) code L02BX02

Publication details

Publication details for Firmagon
Marketing-authorisation holder

Ferring Pharmaceuticals A/S

Revision11
Date of issue of marketing authorisation valid throughout the European Union17/02/2009

Contact address:

Ferring Pharmaceuticals A/S
Kay Fiskers Plads 11
DK-2300 Copenhagen S
Denmark

Product information

Product information

21/11/2014  Firmagon -EMEA/H/C/000986 -PSUV/0023

Name Language First published Last updated
Firmagon : EPAR - Product Information SV = svenska 2008-08-11 2015-01-22
Firmagon : EPAR - Product Information SV = svenska 2008-08-11 2015-01-22
Firmagon : EPAR - Product Information SV = svenska 2008-08-11 2015-01-22
Firmagon : EPAR - Product Information SV = svenska 2008-08-11 2015-01-22
Firmagon : EPAR - Product Information SV = svenska 2008-08-11 2015-01-22
Firmagon : EPAR - Product Information SV = svenska 2008-08-11 2015-01-22
Firmagon : EPAR - Product Information SV = svenska 2008-08-11 2015-01-22
Firmagon : EPAR - Product Information SV = svenska 2008-08-11 2015-01-22
Firmagon : EPAR - Product Information SV = svenska 2008-08-11 2015-01-22
Firmagon : EPAR - Product Information SV = svenska 2008-08-11 2015-01-22
Firmagon : EPAR - Product Information SV = svenska 2008-08-11 2015-01-22
Firmagon : EPAR - Product Information SV = svenska 2008-08-11 2015-01-22
Firmagon : EPAR - Product Information SV = svenska 2008-08-11 2015-01-22
Firmagon : EPAR - Product Information SV = svenska 2008-08-11 2015-01-22
Firmagon : EPAR - Product Information SV = svenska 2008-08-11 2015-01-22
Firmagon : EPAR - Product Information SV = svenska 2008-08-11 2015-01-22
Firmagon : EPAR - Product Information SV = svenska 2008-08-11 2015-01-22
Firmagon : EPAR - Product Information SV = svenska 2008-08-11 2015-01-22
Firmagon : EPAR - Product Information SV = svenska 2008-08-11 2015-01-22
Firmagon : EPAR - Product Information SV = svenska 2008-08-11 2015-01-22
Firmagon : EPAR - Product Information SV = svenska 2008-08-11 2015-01-22
Firmagon : EPAR - Product Information SV = svenska 2008-08-11 2015-01-22
Firmagon : EPAR - Product Information SV = svenska 2008-08-11 2015-01-22
Firmagon : EPAR - Product Information SV = svenska 2008-08-11 2015-01-22
Firmagon : EPAR - Product Information SV = svenska 2008-08-11 2015-01-22

Contents

  • Annex I - Summary of product characteristics
  • Annex IIA - Manufacturing-authorisation holder responsible for batch release
  • Annex IIB - Conditions of the marketing authorisation
  • Annex IIIA - Labelling
  • Annex IIIB - Package leaflet

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.


Name Language First published Last updated
Firmagon : EPAR - All Authorised presentations SV = svenska 2009-03-04 2012-07-24
Firmagon : EPAR - All Authorised presentations SV = svenska 2009-03-04 2012-07-24
Firmagon : EPAR - All Authorised presentations SV = svenska 2009-03-04 2012-07-24
Firmagon : EPAR - All Authorised presentations SV = svenska 2009-03-04 2012-07-24
Firmagon : EPAR - All Authorised presentations SV = svenska 2009-03-04 2012-07-24
Firmagon : EPAR - All Authorised presentations SV = svenska 2009-03-04 2012-07-24
Firmagon : EPAR - All Authorised presentations SV = svenska 2009-03-04 2012-07-24
Firmagon : EPAR - All Authorised presentations SV = svenska 2009-03-04 2012-07-24
Firmagon : EPAR - All Authorised presentations SV = svenska 2009-03-04 2012-07-24
Firmagon : EPAR - All Authorised presentations SV = svenska 2009-03-04 2012-07-24
Firmagon : EPAR - All Authorised presentations SV = svenska 2009-03-04 2012-07-24
Firmagon : EPAR - All Authorised presentations SV = svenska 2009-03-04 2012-07-24
Firmagon : EPAR - All Authorised presentations SV = svenska 2009-03-04 2012-07-24
Firmagon : EPAR - All Authorised presentations SV = svenska 2009-03-04 2012-07-24
Firmagon : EPAR - All Authorised presentations SV = svenska 2009-03-04 2012-07-24
Firmagon : EPAR - All Authorised presentations SV = svenska 2009-03-04 2012-07-24
Firmagon : EPAR - All Authorised presentations SV = svenska 2009-03-04 2012-07-24
Firmagon : EPAR - All Authorised presentations SV = svenska 2009-03-04 2012-07-24
Firmagon : EPAR - All Authorised presentations SV = svenska 2009-03-04 2012-07-24
Firmagon : EPAR - All Authorised presentations SV = svenska 2009-03-04 2012-07-24
Firmagon : EPAR - All Authorised presentations SV = svenska 2009-03-04 2012-07-24
Firmagon : EPAR - All Authorised presentations SV = svenska 2009-03-04 2012-07-24
Firmagon : EPAR - All Authorised presentations SV = svenska 2009-03-04 2012-07-24
Firmagon : EPAR - All Authorised presentations SV = svenska 2009-03-04 2012-07-24

Name Language First published Last updated
Firmagon : EPAR - Conditions imposed on member states for safe and effective use - Annex IV SV = svenska 2009-03-04  
Firmagon : EPAR - Conditions imposed on member states for safe and effective use - Annex IV SV = svenska 2009-03-04  
Firmagon : EPAR - Conditions imposed on member states for safe and effective use - Annex IV SV = svenska 2009-03-04  
Firmagon : EPAR - Conditions imposed on member states for safe and effective use - Annex IV SV = svenska 2009-03-04  
Firmagon : EPAR - Conditions imposed on member states for safe and effective use - Annex IV SV = svenska 2009-03-04  
Firmagon : EPAR - Conditions imposed on member states for safe and effective use - Annex IV SV = svenska 2009-03-04  
Firmagon : EPAR - Conditions imposed on member states for safe and effective use - Annex IV SV = svenska 2009-03-04  
Firmagon : EPAR - Conditions imposed on member states for safe and effective use - Annex IV SV = svenska 2009-03-04  
Firmagon : EPAR - Conditions imposed on member states for safe and effective use - Annex IV SV = svenska 2009-03-04  
Firmagon : EPAR - Conditions imposed on member states for safe and effective use - Annex IV SV = svenska 2009-03-04  
Firmagon : EPAR - Conditions imposed on member states for safe and effective use - Annex IV SV = svenska 2009-03-04  
Firmagon : EPAR - Conditions imposed on member states for safe and effective use - Annex IV SV = svenska 2009-03-04  
Firmagon : EPAR - Conditions imposed on member states for safe and effective use - Annex IV SV = svenska 2009-03-04  
Firmagon : EPAR - Conditions imposed on member states for safe and effective use - Annex IV SV = svenska 2009-03-04  
Firmagon : EPAR - Conditions imposed on member states for safe and effective use - Annex IV SV = svenska 2009-03-04  
Firmagon : EPAR - Conditions imposed on member states for safe and effective use - Annex IV SV = svenska 2009-03-04  
Firmagon : EPAR - Conditions imposed on member states for safe and effective use - Annex IV SV = svenska 2009-03-04  
Firmagon : EPAR - Conditions imposed on member states for safe and effective use - Annex IV SV = svenska 2009-03-04  
Firmagon : EPAR - Conditions imposed on member states for safe and effective use - Annex IV SV = svenska 2009-03-04  
Firmagon : EPAR - Conditions imposed on member states for safe and effective use - Annex IV SV = svenska 2009-03-04  
Firmagon : EPAR - Conditions imposed on member states for safe and effective use - Annex IV SV = svenska 2009-03-04  
Firmagon : EPAR - Conditions imposed on member states for safe and effective use - Annex IV SV = svenska 2009-03-04  

Pharmacotherapeutic group

Endocrine therapy

Therapeutic indication

Firmagon is a gonadotrophin-releasing-hormone (GnRH) antagonist indicated for treatment of adult male patients with advanced hormone-dependent prostate cancer.

Assessment History

Authorised

This medicine is approved for use in the European Union