Firmagon is a man-made form of a protein that reduces the amount of certain hormones in the body, including testosterone.

Firmagon injection is used to treat prostate cancer. It works by decreasing the amount of testosterone in the body, which the tumor needs to grow.

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

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.

Before you receive Firmagon, tell your doctor if you have liver or kidney disease, a personal or family history of "Long QT syndrome," congestive heart failure, or an electrolyte imbalance, such as low or high levels of potassium or magnesium in your blood.

Tell your doctor about all other medications you use, especially a heart rhythm medication.

Firmagon is usually given once every 28 days. Follow your doctor's instructions.

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.

Firmagon is injected under the skin around your stomach. A healthcare provider will give you this injection.

On the day of your injection, avoid wearing a belt, tight waistband, or tight clothing around your stomach where the injection will be given.

Firmagon is usually given once every 28 days. Follow your doctor's instructions.

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 degarelix.

Usual Adult Dose 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.

Use: Treatment of advanced prostate cancer

You should not use Firmagon if you are allergic to degarelix.

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; or

• an electrolyte imbalance, such as low or high levels of potassium, calcium, or magnesium in your blood.

Although Firmagon is not for use by women, degarelix can harm an unborn baby or cause miscarriage if a woman is exposed to it during pregnancy. Degarelix should not be used by a woman who is pregnant.

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

Firmagon also should not be used by a woman who is breastfeeding a baby.

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.

Degarelix 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 hands before and after removing gloves. Wash soiled clothing and linens separately from other laundry.

Get emergency medical help if you have signs of an allergic reaction to Firmagon: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

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); or

• severe headache, blurred vision, pounding in your neck or ears.

Common Firmagon side effects may include:

• hot flashes;

• weight gain;

• abnormal liver function tests; or

• pain, swelling, redness, itching, or a hard lump where the medicine was injected.

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 FDA at 1-800-FDA-1088.

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.