Degarelix

What it is used for

FIRMAGON is a prescription medicine used in the treatment of advanced prostate cancer. It is not known if FIRMAGON is safe or effective in children.

Side effects, and when to stop

FIRMAGON can cause serious side effects, including:

• Serious allergic reactions. Get medical help right away if you get any of these symptoms:

• Disorder of the heart's electrical activity. Your healthcare provider may do tests during treatment with FIRMAGON to check your heart for a condition called long QT syndrome.

The common side effects of FIRMAGON include:

Other side effects include decreased sex drive and erectile function problems.

Tell your healthcare provider if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects.

Call your healthcare provider for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

General information about the safe and effective use of FIRMAGON.

Medicines are sometimes prescribed for conditions that are not mentioned in a Patient Information leaflet. Do not use FIRMAGON for a condition for which it was not prescribed. Do not give FIRMAGON to other people, even if they have the same symptoms that you have. It may harm them.

You can ask your pharmacist or healthcare provider for information about FIRMAGON that is written for health professionals.

Who should not take it

Do not receive FIRMAGON if you are allergic to degarelix or any ingredient in FIRMAGON. See the end of this leaflet for a complete list of ingredients in FIRMAGON.

Talk to your healthcare provider before receiving FIRMAGON if you have any of these conditions.

Before receiving FIRMAGON, tell your healthcare provider about all your medical conditions, including if you:

• have any heart problems including a condition called long QT syndrome.
• have problems with blood levels such as sodium, potassium, calcium, and magnesium
• have kidney or liver problems
• are pregnant or plan to become pregnant. FIRMAGON can cause harm to your unborn baby and loss of pregnancy (miscarriage)
• are breastfeeding or plan to breastfeed. It is not known if FIRMAGON passes into your breast milk. You and your healthcare provider should decide if you will receive FIRMAGON or breastfeed. You should not do both.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Know the medicines you take. Keep a list of them and show it to your healthcare provider and pharmacist when you get a new medicine.

How will I receive FIRMAGON?

You will receive an injection of FIRMAGON from your healthcare provider.

• The injection site will always be in the stomach (abdominal area). The injection site will change within the stomach area each time you receive a dose of FIRMAGON.
• Two injections are given as a first dose. The following monthly doses are one injection.
• Do not rub or scratch the injection site. Make sure your injection site is free of any pressure from belts, waistbands or other types of clothing.
• Always set up an appointment for your next injection.