Firmagon

Firmagon injection is used to treat advanced prostate cancer. It works by decreasing the amount of testosterone in the body, which the tumor needs to grow. It is given by subcutaneous (under the skin) injection once every 28 days by a healthcare provider.

Firmagon is a man-made form of a protein that works by blocking specific hormone receptors in your brain's pituitary gland called GnRH receptors. This immediately stops the chain reaction that leads to testosterone production. Since prostate cancer cells need testosterone to grow, reducing this hormone helps control the cancer's spread and growth. Firmagon belongs to the drug class called GnRH receptor antagonists.

Fimragon gained FDA approval on December 24, 2008. There is no generic.

A healthcare provider will give you this injection.

• The injection site is always under the skin in your stomach area (abdominal area). The injection site will change within the stomach area each time you receive a dose of Firmagon.
• Two injections are given as the first dose. The following monthly doses are one injection.
• Firmagon is usually given once every 28 days. Follow your doctor's instructions.
• On the day of your injection, avoid wearing a belt, tight waistband, or tight clothing around your stomach where the injection will be given.
• Do not rub or scratch the injection site.
• Always set up an appointment for your next injection.

The first time you receive this medicine, you will be given two injections.

• At your monthly follow-up visits, you will receive only one injection.

You will need frequent medical tests.

Firmagon can affect the results of certain medical tests. Tell any doctor who treats you that you are using this medicine.

You should not use Firmagon if you are allergic to degarelix, Firmagon, or any of the inactive ingredients in the injection.

To make sure Firmagon is safe for you, tell your doctor if you have:

• heart problems
• long QT syndrome (in you or a family member)
• liver or kidney disease
• have problems with levels of sodium, potassium, calcium, or magnesium in your blood
• or if you take any medications for your heart, such as heart rhythm medication.

Firmagon is only for use by men.

This medicine may affect fertility (your ability to have children), whether you are a man or a woman.

The most common side effects of Firmagon are:

• injection site pain, redness, and swelling
• hot flashes
• weight gain
• increases in some liver enzymes.

Fimragon may also affect your sex drive and cause erectile dysfunction.

Serious side effects and warnings

Firmagon can cause the following serious side effects:

• Serious allergic reactions. Get medical help right away if you get any of these symptoms: trouble breathing or wheezing severe itching or hives swelling of your face, lips, mouth, or tongue.
• Disorder of the heart’s electrical activity. Androgen deprivation therapy, such as Firmagon, may prolong the QT interval. The benefits of this treatment must be weighed against the risks in patients with congenital long QT syndrome, congestive heart failure, frequent electrolyte abnormalities, and in patients taking other medications known to prolong the QT interval. Your healthcare provider may do tests during treatment with Firmagon to check your heart for long QT syndrome. Your healthcare provider may monitor your heart with electrocardiograms (ECGs) and monitor your electrolytes. Call your doctor at once if you have:

• fast or pounding heartbeats, fluttering in your chest shortness of breath sudden dizziness (like you might pass out) severe headache, blurred vision, pounding in your neck or ears.

Although Firmagon is not for use by women, degarelix should not be used by a woman who is pregnant or breast-feeding, or who may become pregnant.

It is not known if Firmagon is safe or effective in children.

To be sure this medication is helping your condition, your blood may need to be tested on a regular basis. Do not miss any follow-up visits to your doctor.

This is not a complete list of side effects, and others may occur. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Usual Adult Dose of Firmagon for Prostate Cancer:

• Initial Dose: 240 mg administered as 2 subcutaneous injections of 120 mg each at a concentration of 40 mg/mL.
• Maintenance Dose: 80 mg administered as 1 subcutaneous injection at a concentration of 20 mg/mL every 28 days.

Comments: Administer the first maintenance dose 28 days after the initial dose.

Call your doctor for instructions if you miss an appointment for your Firmagon injection.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Avoid rubbing or scratching the skin where the injection was given.

Firmagon can pass into body fluids (urine, feces, vomit). For at least 48 hours after you receive a dose, avoid allowing your body fluids to come into contact with your hands or other surfaces.

• Caregivers should wear rubber gloves while cleaning up a patient's body fluids, handling contaminated trash or laundry, or changing diapers.
• Wash your hands before and after removing gloves. Wash soiled clothing and linens separately from other laundry.

Firmagon can cause a serious heart problem. Your risk may be higher if you also use certain other medicines for infections, asthma, heart problems, high blood pressure, depression, mental illness, cancer, malaria, or HIV.

Other drugs may interact with degarelix, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.

Active ingredient: degarelix (as acetate) Inactive ingredient: mannitol.

Firmagon is made by Ferring Pharmaceuticals in Germany. Ferring Pharmaceuticals also has headquarters in Parsippany, NJ.