Frequently Asked Questions
If you have been diagnosed with prostate cancer or have been prescribed FIRMAGON®, you may have a number of questions and concerns on your mind. You’ll find answers to many of them below.
What is prostate cancer?
Prostate cancer is a disease of the prostate, a walnut-sized gland located beneath the bladder and in front of the rectum in men. The urethra (the tube that transports urine and sperm out of the body) passes through the prostate to the bladder neck. Prostate tissue produces a protein called prostate-specific antigen (PSA) as well as prostatic acid phosphatase, an enzyme found in seminal fluid (the milky substance that combines with sperm to form semen).
Prostate cancer develops when cells in the prostate gland begin to multiply quickly. This means that new cells form where the body does not need them and old cells do not die when they should. These extra cells form a mass of tissue called a tumor. The tumor is described as being “malignant” if the cells have the ability to spread beyond the area in which they first developed.
Prostate cancer usually grows slowly and can remain within the prostate gland for years (localized cancer). However, as the cancer develops, it can invade and damage the surrounding tissues or spread to other areas of the body (metastasis).
What are the symptoms of prostate cancer?
In its early stages, there may be no symptoms. As the cancer grows, you may experience:
- A need to urinate frequently, especially at night
- A need to rush to the toilet, even leaking urine sometimes
- Difficulty starting urination or holding back urine
- Inability to urinate
- A weak flow
- Painful or burning urination
- A sense that the bladder has not emptied
- Difficulty having or keeping an erection
- Painful ejaculation
- Blood in urine or semen
You may also have frequent pain or stiffness in the lower back, hips, or upper thighs.
How is prostate cancer detected?
Tests to detect prostate cancer include:
- Digital rectal examination (DRE):
Your doctor may perform a DRE, inserting a gloved finger into the rectum to feel for hard, lumpy, or abnormal areas of the prostate. - Prostate-specific antigen test (PSA test):
The PSA test measures the level of PSA—a protein produced by the prostate gland—in the blood. An elevated PSA level can indicate the presence of prostate cancer.
If either one of these tests indicates the possibility of prostate cancer, your physician may recommend a biopsy of the prostate. - Transrectal ultrasonography (or ultrasound) (TRUS)/Prostate biopsy:
A probe about the size of a finger is inserted into the rectum to provide images of the prostate by using high-frequency sound waves. This probe is used to help the physician properly place the needle that is projected through the tip of a probe and inserted through the rectum into the prostate. The biopsy needle is used to extract tiny tissue samples from several areas of the prostate. The biopsy samples are sent to a pathologist (a physician who identifies diseases by studying cells under a microscope), who analyzes the samples for the presence of prostate cancer.
What are the stages of prostate cancer?
The stage of prostate cancer tells doctors how far the cancer has spread and helps them decide the best treatment option for you.
Tumors are usually staged using the TNM system:
| T | The size of the primary Tumor |
| N | Whether any lymph Nodes have been affected |
| M | Whether the tumor has Metastasized (spread beyond the prostate gland) |
What are my treatment options?
Decisions regarding how and when to treat prostate cancer are based largely on the stage of the cancer at the time of your diagnosis, whether it is confined to your prostate, or whether it has spread into other areas of your body.
Your doctor will also take into account things like your general health, treatment side effects, and your attitude toward living with these side effects.
Treatment options include:
How does FIRMAGON® work?
FIRMAGON® works differently from other hormone therapies. Its unique action blocks GnRH receptors of the pituitary gland and rapidly reduces your body’s level of testosterone, a hormone that affects the growth of the prostate gland and any cancer cells that may be present.
How will I be treated with FIRMAGON®?
FIRMAGON® is given as a series of injections in your abdomen, administered by your doctor or nurse at the doctor’s office, a hospital, or a clinic.
First you will be given a starting dose of 2 injections. Then you will be given maintenance doses of 1 injection every 28 days.
Once injected, FIRMAGON® forms a small mass, called a depot, which supplies your body with a continuous release of FIRMAGON® over 28 days.
What side effects might I experience with FIRMAGON®?
There are 2 types of effects that may occur following treatment with FIRMAGON®.
- Injection site reactions on your abdomen
- Common side effects
Injection site reactions:
After your starting dose of FIRMAGON®, you might experience the following reactions at the injection site on your abdomen. These reactions are usualy mild and will go away by themselves. If you experience them, pain relievers containing acetaminophen or ibuprofen might be all you need.
- Pain: You might experience soreness or discomfort around the site.
- Redness: You might notice some redness around the site.
- Swelling: Your skin might puff up or bulge above the surrounding skin level, or there might be a lump where the medicine has gelled under your skin.
In clinical studies, all of these reactions were mild to moderate and usually went away within a few days, so you may expect the same. If you experience these reactions, pain relievers such as acetaminophen or ibuprofen can help. Please talk with your health care provider if you have any questions.
Common side effects:
These are usually mild to moderate in intensity.
- Hot flashes
- Flushing of the skin
Less frequent side effects include:
- Weight gain
- Increase in some liver enzymes
- Tiredness
- Hypertension
- Back and joint pain
- Chills
- Urinary tract infection
- Decreased sex drive and erectile dysfunction (impotence)
If you experience any of these or other side effects, and they bother you or do not go away, please tell your health care provider.
How long will I be treated with FIRMAGON®?
At certain times over the course of your treatment, your doctor will measure the level of prostate-specific antigen, or PSA, in your blood. The results of these tests will tell your doctor how well your treatment is working. Based on your test results, your doctor will decide on the length of your treatment.
What if I miss an injection?
You should receive your injection every month. If you cannot keep your appointment to receive the injection, call your health care provider to reschedule another injection date as soon as possible.
This is the best way to ensure control of prostate cancer. After each injection, you should always set up an appointment for your next injection.
INDICATIONS AND USAGE
FIRMAGON® is a GnRH receptor antagonist indicated for treatment of patients with advanced prostate cancer.
IMPORTANT SAFETY INFORMATION
The most commonly observed adverse reactions during FIRMAGON® therapy included injection site reactions (e.g., pain, erythema, swelling or induration), hot flashes, increased weight, fatigue, and increases in serum levels of transaminases and gamma-glutamyltransferase (GGT). 99% of these observed adverse reactions were Grade 1 or 2 (mild to moderate). Specifically relating to the injection site adverse reactions, most were transient, of mild to moderate intensity, occurred primarily with the starting dose and led to few discontinuations (<1%). Grade 3 (severe) injection site reactions occurred in 2% or less of patients receiving FIRMAGON®.
FIRMAGON® is contraindicated in patients with known hypersensitivity to degarelix or to any of the product components. FIRMAGON® is not indicated in women or pediatric patients. Long-term androgen deprivation therapy prolongs the QT interval. Physicians should consider whether the benefits of androgen deprivation therapy outweigh the potential risks in patients with congenital long QT syndrome, electrolyte abnormalities, or congestive heart failure and in patients taking Class IA (e.g., quinidine, procainamide) or Class III (e.g., amiodarone, sotalol) antiarrhythmic medications.
Please see the Full Prescribing Information. You can view or download it by clicking on the link in the right-hand column of the page.
The information on this Web site is provided for educational purposes only. While there may be information on this Web site related to certain medical conditions and their treatment, should a medical condition exist, promptly see your own physician or health care provider as the information on this Web site is not intended to take the place of advice from a physician or health care professional. Ferring does not offer personalized medical diagnosis or patient-specific treatment advice. The statements made by doctors on this Web site represent their own individual experiences and opinions and is not intended to be medical advice. Indeed, only your doctor or other health care professional, as a learned intermediary, can determine if a product described in this Web site is appropriate for you.
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