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FIRMAGON 120 mg POWDER AND SOLVENT FOR INJECTION

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About the medicine

How to use FIRMAGON 120 mg POWDER AND SOLVENT FOR INJECTION

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This page provides general information and does not replace a doctor’s consultation. Always consult a doctor before taking any medication. Seek urgent medical care if symptoms are severe.

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Introduction

Package Leaflet: Information for the User

FIRMAGON 120mgpowder and solvent for solution for injection

degarelix

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

  • Keep this leaflet, you may need to read it again.
  • If you have any further questions, ask your doctor or pharmacist.
  • If you experience any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack and other information:

  1. What is FIRMAGON and what is it used for
  2. What you need to know before you use FIRMAGON
  3. How to use FIRMAGON
  4. Possible side effects
  5. Storage of FIRMAGON
  6. Contents of the pack and further information

1. What is FIRMAGON and what is it used for

FIRMAGON contains degarelix.

Degarelix is a synthetic hormonal blocker used for the treatment of cancer and for the treatment of high-risk prostate cancer before radiotherapy and in combination with radiotherapy in adult male patients. Degarelix mimics the effects of a natural hormone (gonadotropin-releasing hormone, GnRH) by directly blocking its effects. For this reason, degarelix rapidly reduces the levels of the male hormone testosterone, which is responsible for stimulating prostate cancer.

Doctor consultation

Not sure if this medicine is right for you?

Discuss your symptoms and treatment with a doctor online.

2. What you need to know before you use FIRMAGON

Do not use FIRMAGON

  • If you are allergic to the active substance or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Tell your doctor if you have:

  • Any vascular condition or heart rhythm problems (arrhythmias) or if you are being treated with medicines to correct this condition. The risk of heart rhythm problems may be increased with the use of FIRMAGON.
  • Diabetes mellitus. Worsening or onset of diabetes may occur. If you have diabetes, you may need to check your blood sugar levels more often.
  • Liver disease. You may need to have your liver function monitored.
  • Kidney disease. The use of FIRMAGON has not been investigated in patients with severe kidney disease.
  • Osteoporosis or any condition that affects bone density. Reduced testosterone levels can cause a reduction in bone calcium (thinning of the bones).
  • Severe hypersensitivity. The use of FIRMAGON has not been investigated in patients with severe hypersensitivity reactions.

Children and adolescents

Do not give this medicine to children or adolescents.

Using FIRMAGON with other medicines

FIRMAGON may interfere with some medicines used to treat heart rhythm problems (e.g. quinidine, procainamide, amiodarone, and sotalol) or with medicines that affect heart rhythm (e.g. methadone (used for pain relief and as part of drug detoxification), moxifloxacin (an antibiotic), antipsychotics).

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines.

Driving and using machines

Fatigue and dizziness are common side effects that may affect your ability to drive and use machines. These side effects may be due to treatment or may be derived from the underlying disease.

3. How to use FIRMAGON

Generally, the injection of this medicine will be performed by a nurse or doctor.

The recommended starting dose is two consecutive injections of 120 mg. After that, you will be injected with a monthly dose of 80 mg. The liquid that is injected forms a gel from which degarelix is released over a month.

FIRMAGON SHOULD ONLY be injected under the skin (subcutaneous injection). FIRMAGON SHOULD NOT be administered into a blood vessel (intravenous injection). Particular care should be taken to avoid accidental injection into a vein. It is usual to vary the injection site at different points on the abdominal wall.

If you miss a dose of FIRMAGON

If you think you have missed your monthly dose of FIRMAGON, ask your doctor.

If you have any other questions about the use of this medicine, ask your doctor or pharmacist.

Medicine questions

Started taking the medicine and have questions?

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4. Possible side effects

Like all medicines, FIRMAGON can cause side effects, although not everybody gets them.

A very severe allergic reaction to this medicine is rare. Contact your doctor immediately if you develop a severe skin rash, itching, or difficulty breathing. This could be a symptom of a severe allergic reaction.

Very common (may affect more than 1 in 10 people)

Hot flushes, injection site reactions, and redness. Injection site reactions occur more frequently with the starting dose and are less frequent when administering the maintenance dose.

Common (may affect up to 1 in 10 people)

  • Swelling, nodule, and hardness at the injection site
  • Chills, fever, or flu-like symptoms after injection
  • Difficulty sleeping, fatigue, dizziness, headache
  • Weight gain, nausea, diarrhea, increased liver enzymes
  • Excessive sweating (including night sweats), skin rash
  • Anemia
  • Musculoskeletal pain and discomfort
  • Reduced testicle size, breast tenderness, impotence

Uncommon (may affect up to 1 in 100 people)

  • Loss of sexual desire, testicular pain, pelvic pain, interruption of ejaculation, genital irritation, chest pain
  • Depression, mental impairment
  • Skin discoloration, hair loss, skin nodules, numbness
  • Allergic reactions, hives, itching
  • Decreased appetite, constipation, vomiting, dry mouth, abdominal pain and discomfort, increased blood sugar/diabetes mellitus, increased cholesterol, changes in blood calcium levels, weight loss
  • High blood pressure, changes in heart rhythm, changes in electrocardiogram (QT prolongation), abnormal heart pumping sensation, shortness of breath, peripheral edema
  • Muscle weakness, muscle spasms, joint swelling/stiffness, osteoporosis/osteopenia, joint pain
  • Frequent urination, urgent urination (sudden need to urinate), difficulty or pain when urinating, need to urinate at night, kidney function impairment, incontinence
  • Blurred vision
  • Injection site reaction including decreased blood pressure and heart rate (vasovagal reaction)
  • Discomfort

Rare (may affect up to 1 in 1,000 people)

  • Febrile neutropenia (very low white blood cell count in the blood in combination with fever), heart attack, heart failure
  • Unexplained muscle pain or cramps, sensitivity, or weakness. Muscle problems can be severe, including muscle breakdown that can damage the kidneys.

Very rare (may affect up to 1 in 10,000 people)

  • Injection site infection, abscess, and necrosis

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of FIRMAGON

Keep out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the vials, syringes, and carton. The expiry date is the last day of the month stated.

This medicine does not require any special storage conditions.

After reconstitution

This medicine is stable for 2 hours at 25°C.

Due to the risk of microbiological contamination, the medicine should be used immediately. If not used immediately, the use of this medicine will be the responsibility of the user.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and further information

Composition of FIRMAGON

  • The active substance is degarelix. Each vial contains 120 mg of degarelix (as acetate). After reconstitution, 1 ml of reconstituted solution contains 40 mg of degarelix.
  • The other ingredient of the powder is mannitol (E 421).
  • The solvent is water for injections.

Appearance and pack contents of FIRMAGON

FIRMAGON is a powder and solvent for solution for injection. The powder is white to off-white. The solvent is a clear and colorless solution.

Pack size of 2 trays containing:

2 vials of powder containing 120 mg of degarelix and 2 pre-filled syringes containing 3 ml of solvent.

2 plunger stoppers, 2 vial adapters, and 2 needles for injection.

Marketing authorisation holder and manufacturer

Marketing authorisation holder:

Ferring Pharmaceuticals A/S

Amager Strandvej 405

2770 Kastrup, Denmark

Tel. +45 8833 8834

Manufacturer:

Ferring GmbH

Wittland 11

D-24109 Kiel, Germany

You can request more information about this medicine from the local representative of the marketing authorisation holder:

Belgium

Ferring N.V.

Tel: +32 53 72 92 00

[email protected]

Lithuania

CentralPharma Communication UAB

Tel: +370 5 243 0444

[email protected]

Bulgaria

Farmont Ltd.

Tel: +359 2 807 5022

[email protected]

Luxembourg

Ferring N.V.

Belgium

Tel: +32 53 72 92 00

[email protected]

Czech Republic

Ferring Pharmaceuticals CZ s.r.o.

Tel: +420 234 701 333

[email protected]

Hungary

Ferring Magyarország Gyógyszerkereskedelmi Kft.

Tel: +36 1 236 3800

[email protected]

Denmark

Ferring Lægemidler A/S

Tel: +45 88 16 88 17

Malta

E.J. Busuttil Ltd.

Tel: +356 21447184

[email protected]

Germany

Ferring Arzneimittel GmbH

Tel: +49 431 5852 0

[email protected]

Netherlands

Ferring B.V.

Tel: +31 235680300

[email protected]

Estonia

CentralPharma Communication OÜ

Tel: +372 601 5540

[email protected]

Norway

Ferring Legemidler AS

Tel: +47 22 02 08 80

[email protected]

Greece

Ferring Ελλάς ΜΕΠΕ

Tel: +30 210 68 43 449

Austria

Ferring Arzneimittel Ges.m.b.H.

Tel: +43 1 60 8080

[email protected]

Spain

Ferring, S.A.U.

Tel: +34 91 387 70 00

[email protected]

Poland

Ferring Pharmaceuticals Poland Sp. z o.o.

Tel: +48 22 246 06 80

[email protected]

France

Ferring S.A.S.

Tel: +33 1 49 08 67 60

[email protected]

Portugal

Ferring Portuguesa – Produtos Farmacêuticos, Sociedade Unipessoal, Lda.

Tel: +351 21 940 5190

Croatia

Clinres farmacija d.o.o.

Tel: +385 1 2396 900

[email protected]

Romania

Ferring Pharmaceuticals Romania SRL

Tel: +40 356 113 270

Ireland

Ferring Ireland Ltd.

Tel: + 353 1 4637355

[email protected]

Slovenia

SALUS, Veletrgovina, d.o.o.

Tel: +386 1 5899 179

[email protected]

Iceland

Vistor hf.

Tel: +354 535 70 00

Slovakia

Ferring Slovakia s.r.o.

Tel: +421 2 54 416 010

[email protected]

Italy

Ferring S.p.A.

Tel: +39 02 640 00 11

Finland

Ferring Lääkkeet Oy

Tel: +358 207 401 440

[email protected]

Cyprus

  • Potamitis Medicare Ltd

Tel: +357 22583333

[email protected]

Sweden

Ferring Läkemedel AB

Tel: +46 40 691 69 00

[email protected]

Date of last revision of this leaflet:

Detailed information on this medicine is available on the European Medicines Agency web site http://www.ema.europa.eu/.

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This information is intended only for healthcare professionals:

Instructions for correct use

NOTE:

  • THE VIALS SHOULD NOT BE SHAKEN

The pack contains two vials of powder and two pre-filled syringes with solvent that need to be prepared for subcutaneous injection. Therefore, the procedure described should be repeated a second time.

Hand holding an injection device with protective cap and transparent cylinder with white powder, black arrow indicating direction

  1. Remove the cover from the pack with the vial adapter. Insert the adapter into the powder vial by pressing the adapter down until the tip pierces the rubber stopper and the adapter is in place.
  1. Prepare the pre-filled syringe by inserting the plunger stopper.

Connection of two cylindrical devices with needles, hands holding and arrows indicating direction of connection

  1. Remove the cap from the pre-filled syringe. Insert the syringe into the powder vial by screwing it onto the adapter. Transfer all the solvent into the powder vial.

Hand holding syringe with needle inserted into vial of medicine, curved arrows indicating rotation of vial

  1. With the syringe still inserted into the adapter, move the vial in a circular motion very slowly until the liquid is clear and there are no undissolved powder or particles. If the powder adheres to the vial wall above the liquid surface, the vial may be tilted slightly. Avoid shaking to prevent foam formation.

Small circular air bubbles may be acceptable. The reconstitution process usually takes a few minutes, but in some cases, it may take up to 15 minutes.

Hand holding a syringe with needle connected to a vial of transparent medicine with 3 ml indicator and black arrow

  1. Hold the vial upside down and align it with the mark on the syringe for injection.

Always make sure to withdraw the exact volumeand adjust if air bubbles form

  1. Remove the syringe from the vial adapter and insert the needle for subcutaneous injection into the syringe.

Hand holding syringe at a 45-degree angle inserting needle into arm skin, number 7 indicating injection step

  1. Administer by deep subcutaneous injection. To do this: pinch the skin of the abdomen, forming a fold, and insert the needle deeply at an angle of at least 45 degrees with the base of the fold.

Inject 3 ml of FIRMAGON 120mgslowly, immediately after reconstitution*

  1. The injections should be performed in areas that are not subject to local pressure, for example, not too close to the waist or too close to the costal area.

Do not inject directly into any vein. Gently pull back the plunger to check if blood has been aspirated. If blood enters the syringe, the product cannot be used. In this case, remove and discard the syringe and needle (reconstitute a new dose for the patient).

  1. Repeat the reconstitution process for the second dose. Choose a different injection site and inject 3 ml.
  • Chemical and physical stability of the reconstituted product has been demonstrated for 2 hours at 25°C. From a microbiological point of view, unless the method of reconstitution implies a risk of contamination, the product should be used immediately. If not used immediately, the conditions and duration of use will be the responsibility of the user.

Online doctors for FIRMAGON 120 mg POWDER AND SOLVENT FOR INJECTION

Discuss questions about FIRMAGON 120 mg POWDER AND SOLVENT FOR INJECTION, including use, safety considerations and prescription review, subject to medical assessment and local regulations.

5.0 (3)
Doctor

Томаш Гжеловський

Dermatology 21 years exp.

Dr Tomasz Grzelewski is an MD, PhD specialist in allergy, paediatrics, general practice and sports medicine, with a clinical focus on dermatology, endocrinology, allergology and sports-related health. He has more than 20 years of clinical experience and completed his medical training at the Medical University of Łódź, where he defended his PhD thesis with distinction. His doctoral research was recognised by the Polish Society of Allergology for its innovative contribution to the field. Throughout his career, he has gained extensive expertise in diagnosing and managing a wide range of allergic and paediatric conditions, including modern allergen desensitisation techniques.

For five years, Dr Grzelewski served as the Head of two paediatric departments in Poland, managing complex clinical cases and leading multidisciplinary teams. He also worked in medical centres in the United Kingdom, gaining experience across both primary care and specialist environments. With over a decade of telemedicine experience, he has provided online consultations across Europe and is valued for his clear, structured and evidence-based medical guidance.

Dr Grzelewski is actively involved in clinical programmes focused on modern anti-allergic therapies. As a Principal Investigator, he leads research projects on sublingual and oral allergen desensitisation, supporting evidence-based progress in allergy treatment for both children and adults.

In addition to his background in allergology and paediatrics, he completed dermatology studies through the Cambridge Education Group (Royal College of Physicians of Ireland) and a Clinical Endocrinology course at Harvard Medical School. This advanced training enhances his ability to manage skin manifestations of allergies, atopic conditions, urticaria, endocrine-related symptoms and complex immunological reactions.

Patients commonly seek his care for:

  • seasonal and perennial allergies
  • allergic rhinitis and chronic nasal symptoms
  • asthma and breathing difficulties
  • food and medication allergies
  • urticaria, atopic dermatitis and skin reactions
  • recurrent infections in children
  • sports-related health questions
  • general family medicine concerns
Dr Tomasz Grzelewski is known for his clear communication style, structured medical approach and ability to explain treatment options in a concise and accessible way. His multidisciplinary background across allergy, paediatrics, dermatology and endocrinology allows him to provide safe, up-to-date and comprehensive care for patients of all ages.
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Anna Biriukova

General medicine 6 years exp.

Dr Anna Biriukova is an internal medicine doctor with clinical experience in cardiology, endocrinology, and gastroenterology. She provides online consultations for adults, offering expert medical support for heart health, hormonal balance, digestive issues, and general internal medicine.

Cardiology – Diagnosis and treatment of:

  • High blood pressure, blood pressure fluctuations, and cardiovascular risk prevention.
  • Chest pain, shortness of breath, arrhythmias (tachycardia, bradycardia, palpitations).
  • Leg swelling, chronic fatigue, reduced exercise tolerance.
  • EKG interpretation, lipid profile evaluation, cardiovascular risk assessment (heart attack, stroke).
  • Post-COVID-19 cardiac monitoring and care.
Endocrinology – Diabetes, thyroid, metabolism:
  • Diagnosis and management of type 1 and type 2 diabetes, and prediabetes.
  • Individual treatment plans including oral medications and insulin therapy.
  • GLP-1 therapy– modern pharmacological treatment for weight management and diabetes control, including drug selection, monitoring, and safety follow-up.
  • Thyroid disorders – hypothyroidism, hyperthyroidism, autoimmune thyroid diseases (Hashimoto’s, Graves’ disease).
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  • Stomach and intestinal conditions: gastritis, irritable bowel syndrome (IBS), indigestion.
  • Management of chronic digestive disorders and interpretation of tests (endoscopy, ultrasound, labs).
General internal medicine and preventive care:
  • Respiratory infections – cough, colds, bronchitis.
  • Lab test analysis, therapy adjustments, medication management.
  • Adult vaccinations – planning, contraindications assessment.
  • Cancer prevention – screening strategies and risk assessment.
  • Holistic approach – symptom relief, complication prevention, and quality of life improvement.
Dr Biriukova combines internal medicine with specialist insight, offering clear explanations, personalised treatment plans, and comprehensive care tailored to each patient.
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Dmytro Horobets

Family medicine 7 years exp.

Dr. Dmytro Horobets is a licensed family medicine physician in Poland, specialising in endocrinology, diabetology, obesity management, gastroenterology, pediatrics, general surgery, and pain medicine. He offers online consultations for adults and children, providing personalised medical support for a wide range of acute and chronic health concerns.

Areas of expertise:

  • Endocrinology: diabetes type 1 and type 2, prediabetes, thyroid disorders, metabolic syndrome, hormonal imbalance.
  • Obesity medicine: structured weight management plans, nutritional counselling, obesity-related health risks.
  • Gastroenterology: acid reflux (GERD), gastritis, irritable bowel syndrome (IBS), liver and biliary conditions.
  • Pediatric care: infections, respiratory symptoms, digestive issues, growth and development monitoring.
  • General surgery support: pre- and post-surgical consultations, wound care, rehabilitation.
  • Pain management: chronic and acute pain, back pain, joint pain, post-traumatic pain syndromes.
  • Cardiovascular health: hypertension, cholesterol control, risk assessment for heart disease.
  • Preventive medicine: regular check-ups, health screenings, long-term management of chronic conditions.

Dr. Horobets combines evidence-based medicine with a patient-centred approach. He carefully evaluates each patient’s medical history and symptoms, offering clear explanations and structured treatment plans adapted to individual needs.

Whether you need help managing diabetes, tackling weight-related health issues, interpreting lab results, or receiving general family medicine support, Dr. Horobets provides professional online care tailored to your specific health goals.

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Doctor

Giorgi Eremeishvili

Urology 22 years exp.

Giorgi Eremeishvili is a top-category urologist, a Candidate of Medical Sciences, and a licensed physician in Spain. He provides expert assistance in the diagnosis and treatment of a wide range of urological conditions in both men and women, employing a comprehensive approach and evidence-based principles.

Key areas of expertise:

  • Erectile dysfunction, decreased libido, premature ejaculation.
  • Male infertility: comprehensive diagnosis and modern treatment methods.
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  • Inflammatory diseases of the genitourinary system: acute and chronic cystitis, pyelonephritis, epididymitis, orchitis, urethritis.
  • Sexually transmitted infections (STIs): chlamydia, ureaplasmosis, mycoplasmosis, gardnerellosis, candidiasis, herpetic infections, HPV, CMV, trichomoniasis, and others.
  • Urination disorders: urinary retention, frequent urination, urinary incontinence, overactive bladder, neurogenic bladder.
  • Neoplasms: cysts, tumors of the kidneys, bladder, testicles, prostate gland (including prostate cancer).
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Dr. Eremeishvili applies an integrated approach to each case. This includes thorough preoperative preparation, postoperative observation, and regular dynamic follow-up during the treatment process to achieve the best possible outcomes. All diagnostic and therapeutic recommendations are based on current evidence-based medicine and comply with the recommendations of the European Association of Urology, guaranteeing high-quality and effective care.

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Frequently Asked Questions

Is a prescription required for FIRMAGON 120 mg POWDER AND SOLVENT FOR INJECTION?
FIRMAGON 120 mg POWDER AND SOLVENT FOR INJECTION requires a prescription in Spain. You can check with a doctor online whether this medicine may be appropriate for your situation.
What is the active substance in FIRMAGON 120 mg POWDER AND SOLVENT FOR INJECTION?
The active ingredient in FIRMAGON 120 mg POWDER AND SOLVENT FOR INJECTION is degarelix. This information helps identify medicines with the same composition but different brand names.
Who manufactures FIRMAGON 120 mg POWDER AND SOLVENT FOR INJECTION?
FIRMAGON 120 mg POWDER AND SOLVENT FOR INJECTION is manufactured by Ferring Pharmaceuticals A/S. Pharmacy brands and packaging may differ depending on the distributor.
Which doctors can assess the use of FIRMAGON 120 mg POWDER AND SOLVENT FOR INJECTION online?
Doctors such as Family doctors, Psychiatrists, Dermatologists, Cardiologists, Endocrinologists, Gastroenterologists, Pulmonologists, Nephrologists, Rheumatologists, Hematologists, Infectious disease physicians, Allergists, Geriatricians, Paediatricians, Oncologists may assess whether FIRMAGON 120 mg POWDER AND SOLVENT FOR INJECTION is appropriate, depending on your situation and local regulations. You can book an online consultation to discuss your symptoms and possible next steps.
What are the alternatives to FIRMAGON 120 mg POWDER AND SOLVENT FOR INJECTION?
Other medicines with the same active substance (degarelix) include FIRMAGON 80 mg POWDER AND SOLVENT FOR INJECTABLE SOLUTION, ABIRATERONE ACCORD 250 mg TABLETS, ABIRATERONE ACCORD 500 mg FILM-COATED TABLETS. These may have different brand names or formulations but contain the same therapeutic ingredient. Always consult a doctor before switching or starting a new medicine.
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