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Firmagon (Degarelix): Uses, Side Effects and Dosage

Status:
Prescription (Rx) Facts
Strength:
40 mg/mL, 20 mg/mL
Drug class:
Active ingredient:
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Source: FDA drug labeling via NLM DailyMed · About this document

Patient information: uses, side effects, how to take - Firmagon

What is FIRMAGON?

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.

Who should not receive FIRMAGON?

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.

What are the possible side effects of FIRMAGON?

FIRMAGON can cause serious side effects, including:

  • Serious allergic reactions. Get medical help right away if you get any of these symptoms:
  • trouble breathing or wheezing
  • severe itching
  • swelling of your face, lips, mouth, or tongue
  • 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:

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

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.

What are the ingredients in FIRMAGON?

Active ingredient: degarelix (as acetate)

Inactive ingredient: mannitol

MANUFACTURED FOR:

FERRING PHARMACEUTICALS INC., PARSIPPANY, NJ 07054

Manufactured in Germany

For more information, go to www.FIRMAGON.com or call 1-888-337-7464.

This Patient Information has been approved by the U.S. Food and Drug Administration.

02/2020

About this document

Source: FDA drug labeling via NLM DailyMed · Application number: NDA 022201 · View the label on DailyMed

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The information on this site does not replace the advice of a doctor or pharmacist.

Drug information for Firmagon

Rx or OTC
Prescription (Rx)?
  • This drug is available only with a prescription from a licensed healthcare provider.
  • Rx
Drug class Gonadotropin Releasing Hormone Receptor Antagonist
Active ingredient Degarelix
Dosage form Kit
Marketing status listed in the FDA NDC Directory
Company (applicant) FERRING
FDA approval NDA 022201New Drug Application (NDA) Approved December 24, 2008
Reference listed drug This is the reference listed drug (RLD) that generics are compared with.
Manufacturers 1 labelers list this drug on DailyMed
Packages (NDC)
Package
40 mg/mL – 1 in 1 carton NDC 55566-8403-1
20 mg/mL – 1 in 1 carton NDC 55566-8303-1

Source: FDA drug labeling via NLM DailyMed, data as of October 31, 2026. FDA data (DailyMed, Orange Book, Drug Shortages, enforcement reports). Not a substitute for the advice of a doctor or pharmacist.