Firmagon - degarelix

What is Firmagon?

Firmagon consists of a powder and a solvent for preparing a solution for injection. The active ingredient contained in it 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, that is the gland that in men is located under the bladder and that produces seminal fluid. By "advanced stage" we mean the fact that cancer has affected not only the prostate but also some lymph nodes, but not other organs Firmagon can be used if it is "hormone-dependent" cancer, that is, if the cancer responds to treatments that lower 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 muscle. Doctors should check the effectiveness of Firmagon therapy by testing blood levels of testosterone and prostate specific antigen (PSA). PSA is a protein produced by the prostate and is often present at high levels in men with cancer of the prostate. prostate.
Firmagon should be used with caution in patients with severe kidney or liver problems.

How does Firmagon work?

Testosterone can cause prostate cancer cells to grow. The active substance in Firmagon, degarelix, is a gonadotropin-releasing hormone antagonist, which means it blocks the effects of a natural hormone, the gonadotropin-releasing hormone (GnRH). Normally, GnRH stimulates the pituitary gland at the base of the brain to produce two hormones which in turn cause the testes to produce testosterone. By inhibiting these processes, Firmagon lowers the amount of testosterone in the body, slowing down growth. of cancerous cells. After injection, Firmagon forms a gel deposit under the skin which releases the active ingredient slowly over a few weeks.

How has Firmagon been studied?

Firmagon's effects were first tested in experimental models before being studied in humans.
Two doses of Firmagon were 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 lower than those seen 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 found to be as effective as leuprorelin in reducing testosterone levels. During the first year, 97% of patients treated with Firmagon at the licensed dose of 80 mg once monthly testosterone levels were below the target level compared with 96% of patients treated with leuprorelin. Similar results were seen in patients treated with Firmagon at a dose greater than 160 mg once monthly.

What is the risk associated with Firmagon?

The most common side effects associated with Firmagon (i.e. seen in more than 1 in 10 patients) are hot flushes and injection site problems, such as pain and redness. For the full list of 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 Firmagon was found to be as effective as leuprorelin in the main study. However, as the main study looked at the drug's effects on testosterone levels rather than directly examining cancer or patient outcomes, and as leuprorelin is only used for advanced prostate cancer, the committee decided to limit the use of Firmagon for advanced prostate cancer only.
The committee also noted that Firmagon treatment does not cause the marked transient rise in testosterone levels seen with "GnRH agonists" (other prostate cancer drugs that stimulate GnRH production). This means that patients do not need to take other drugs 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 advanced hormone-dependent prostate cancer in adult males. The committee recommended the granting of a marketing authorization for Firmagon.

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 will prescribe the medicine receive educational materials. These materials will contain information on the safety of Firmagon and guidance on administering the medicine.

Other information about Firmagon:

On February 17, 2009, the European Commission granted Ferring Pharmaceuticals A / S a "Marketing Authorization" for Firmagon, valid throughout the European Union.
For the full version of Firmagon's EPAR, click here.

Last update of this summary: 01-2009.

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