What is Firmagon?
Firmagon consists of a powder and a solvent for the preparation of a solution for injection. The active ingredient it contains is degarelix.
What is Firmagon used for?
Firmagon is used to treat patients with advanced prostate cancer. It is a cancer that affects the prostate, which is the gland that is found under the bladder in humans and produces seminal fluid. By "advanced stage" we mean the fact that the cancer has affected not only the prostate but also some lymph nodes, even if not other organs. Firmagon can be used if it is "hormone dependent" cancer, or if the cancer 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 begins with two 120 mg injections followed by a single 80 mg injection once a month. Firmagon should not be injected into a vein or into a muscle. The doctor should monitor the effectiveness of Firmagon therapy by analyzing blood testosterone levels and prostate specific antigen (PSA). PSA is a protein produced by the prostate and is often present at high levels in men with prostate cancer.
Firmagon should be used with caution in patients with severe kidney or liver problems.
How does Firmagon work?
Testosterone can cause prostate cancer cell growth. The active substance in Firmagon, degarelix, is an antagonist of the gonadotropin-releasing hormone, ie it blocks the effects of a natural hormone, the gonadotropin-releasing hormone (GnRH). Normally GnRH stimulates the pituitary gland, which is located at the base of the brain, to produce two hormones which in turn induce the testes to produce testosterone. By blocking these processes, Firmagon lowers the amount of testosterone in the body, slowing the growth of cancer cells. After the injection, Firmagon forms a gel deposit under the skin that releases the active ingredient slowly over the course of 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 were compared to 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 lower than those observed in patients with testicles that did not produce testosterone in the first year of treatment.
What benefit has Firmagon shown during the studies?
Firmagon was as effective as leuprorelin in reducing testosterone levels. During the first year, in 97% of patients treated with Firmagon at the authorized dose of 80 mg once a month, testosterone levels were below the established level compared to 96% of patients treated with leuprorelin. Similar results occurred in patients treated with Firmagon at a dose greater than 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 patients 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, in the main study, Firmagon was as effective as leuprorelin. However, as the main study examined the effects of the drug on testosterone levels rather than directly examining cancer or patient outcomes, and because leuprorelin is used only for advanced prostate cancer, the committee decided to limit the use of Firmagon in advanced prostate cancer alone.
The committee also noted that treatment with Firmagon does not cause the marked transient rise in testosterone levels observed with "GnRH agonists" (other prostate cancer drugs that stimulate GnRH production). This means that at the start of treatment, patients do not need to take other drugs to block testosterone.
Therefore the CHMP decided that Firmagon's benefits are greater than its risks for the treatment of advanced hormone-dependent prostate cancer in adult males. The Committee recommended that Firmagon be given marketing authorization.
What measures are being taken to ensure the safe use of Firmagon?
The company that makes Firmagon is committed to ensuring that all doctors in all Member States who prescribe the medicine receive informational materials. These materials will contain information on the safety of Firmagon and indications on the administration of the medicine.
More information on Firmagon:
On 17 February 2009, the European Commission issued a marketing authorization valid for Firmagon, valid throughout the European Union, to Ferring Pharmaceuticals A / S.
For the full EPAR version of Firmagon, click here.
Last update of this summary: 01-2009.
