Firmagon

Generic Name: degarelix (DEG a REL ix)
Brand Names: Firmagon

What is Firmagon?

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

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

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

Important information about Firmagon

You should not use this medication if you are allergic to Firmagon. Although Firmagon 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.

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.

Before receiving Firmagon

You should not use this medication if you are allergic to Firmagon.

If you have any of these other conditions, you may need a dose adjustment or special tests to safely use Firmagon:

• liver disease;

• 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.

Although Firmagon is not for use by women, this medication can cause birth defects if a woman is exposed to it during pregnancy. Firmagon should not be used by a woman who is pregnant. It is not known whether this medication passes into breast milk or if it could harm a nursing baby. Firmagon should not be used by a woman who is breast-feeding a baby.

How is Firmagon given?

Firmagon is given as an injection under the skin of your stomach. Your doctor, nurse, or other healthcare provider will give you this injection.

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

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

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.

What happens if I miss a dose?

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

What happens if I overdose?

Seek emergency medical attention if you think you have received too much of this medicine.

Symptoms of a Firmagon overdose are not known.

What should I avoid while receiving Firmagon?

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

Firmagon side effects

Get emergency medical help if you have any of these 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 a serious side effect such as:

• dizziness, fainting, fast or pounding heartbeat;

• pain or burning when you urinate;

• feeling short of breath, even with mild exertion;

• swelling in your hands, ankles, or feet; or

• dangerously high blood pressure (severe headache, blurred vision, buzzing in your ears, anxiety, confusion, chest pain, shortness of breath, uneven heartbeats, seizure).

Less serious Firmagon side effects may include:

• headache;

• chills or hot flashes;

• sweating more than usual;

• weight gain;

• weakness, tired feeling;

• joint pain;

• back pain;

• nausea, constipation, diarrhea;

• impotence, loss of interest in sex, or trouble having an orgasm;

• breast swelling or enlargement; 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 Firmagon?

Tell your doctor about all other medications you use, especially a heart rhythm medication such as:

• amiodarone (Cordarone, Pacerone);

• bretylium (Bretylan, Tosylate);

• disopyramide (Norpace);

• dofetilide (Tikosyn);

• flecaininde (Tambocor);

• ibutilide (Corvert);

• mexiletine (Mexitil);

• morizicine (Ethmozine);

• procainamide (Procan, Procanbid, Pronestyl);

• propafenone (Rythmol);

• propafenone (Rythmol);

• quinidine (Quinaglute, Quinidex, Quin-Release); or

• sotalol (Betapace).

This list is not complete and there may be other drugs that can interact with Firmagon. Tell your doctor about all your prescription and over-the-counter medications, vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start a new medication without telling your doctor.

Where can I get more information?

• Your doctor or pharmacist can provide more information about Firmagon.

• Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2009 Cerner Multum, Inc. Version: 2.01. Revision Date: 08/23/2009 15:50:24 PM.

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