Pronunciation: DEG a REL ix

Brand: Firmagon

What is the most important information I should know about degarelix?

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

What is degarelix?

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

Degarelix is used to treat prostate cancer.

Degarelix may also be used for purposes not listed in this medication guide.

What should I discuss with my health care provider before receiving degarelix?

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

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

  • heart disease, heart rhythm disorder;
  • a personal or family history of Long QT syndrome;
  • liver or kidney disease; or
  • an electrolyte imbalance, such as low or high levels of potassium or magnesium in your blood.

Although degarelix is not for use by women, this medicine can cause birth defects if a woman is exposed to it during pregnancy. Degarelix should not be used by a woman who is pregnant.

It is not known whether this medicine passes into breast milk or if it could harm a nursing baby. Degarelix should not be used by a woman who is breast-feeding a baby.

How is degarelix given?

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

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

The first time you receive degarelix, you will be given two injections. At your monthly follow-up visits you will receive only one injection.

While using degarelix, you may need frequent blood tests at your doctor's office.

What happens if I miss a dose?

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

What happens if I overdose?

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

What should I avoid while receiving degarelix?

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

This medicine can pass into body fluids (including 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. Patients and caregivers should wear rubber gloves while cleaning up 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.

What are the possible side effects of degarelix?

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

Call your doctor at once if you have:

  • headache with chest pain and severe dizziness, fainting, fast or pounding heartbeats;
  • pain or burning when you urinate;
  • shortness of breath (even with mild exertion), swelling, rapid weight gain; or
  • dangerously high blood pressure --severe headache, blurred vision, pounding in your neck or ears, nosebleed, anxiety, confusion, severe chest pain, shortness of breath, irregular heartbeats.

Common side effects may include:

  • feeling tired;
  • chills or hot flashes;
  • weight gain;
  • abnormal liver function tests;
  • joint pain, back pain;
  • increased blood pressure;
  • impotence, loss of interest in sex, trouble having an orgasm; or
  • pain, swelling, redness, 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.

What other drugs will affect degarelix?

Tell your doctor about all your current medicines and any you start or stop using, especially:

  • heart rhythm medicine--amiodarone, disopyramide, dofetilide, dronedarone, flecainide, procainamide, quinidine, sotalol, and others.

This list is not complete. Other drugs may interact with degarelix, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.

Where can I get more information?

Your doctor or pharmacist can provide more information about degarelix.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

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