Firmagon

1 
 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

ANNEX I 
 

SUMMARY OF PRODUCT CHARACTERISTICS 
 



2 
 

1. NAME OF THE MEDICINAL PRODUCT 
 
FIRMAGON 80 mg powder and solvent for solution for injection 
FIRMAGON 120 mg powder and solvent for solution for injection 
 
2. QUALITATIVE AND QUANTITATIVE COMPOSITION 
 
FIRMAGON 80 mg powder and solvent for solution for injection 
 
Each vial contains 80 mg degarelix (as acetate). After reconstitution, each ml of solution contains 20 mg of 
degarelix. 
 
FIRMAGON 120 mg powder and solvent for solution for injection 
 
Each vial contains 120 mg degarelix (as acetate). After reconstitution, each ml of solution contains 40 mg of 
degarelix. 
 
For the full list of excipients, see section 6.1. 
 
 
3. PHARMACEUTICAL FORM 
 
Powder and solvent for solution for injection 
 
Powder: white to off-white powder. 
Solvent: clear, colourless solution. 
 
 
4. CLINICAL PARTICULARS 
 
4.1 Therapeutic indications 
 
FIRMAGON is a gonadotrophin releasing hormone (GnRH) antagonist indicated for treatment of adult male 
patients with advanced hormone-dependent prostate cancer.  
 
4.2 Posology and method of administration 
 
Posology 
 
Starting dose Maintenance dose – monthly 

administration  

240 mg administered as two consecutive 
subcutaneous injections of 120 mg each 

80 mg administered as one subcutaneous 
injection  

 
The first maintenance dose should be given one month after the starting dose. 
 
The therapeutic effect of degarelix should be monitored by clinical parameters and prostate specific antigen 
(PSA) serum levels. Clinical studies have shown that testosterone (T) suppression occurs immediately after 
administration of the starting dose with 96% of the patients having serum testosterone levels corresponding 
to medical castration (T≤0.5 ng/ml) after three days and 100% after one month. Long term treatment with the 
maintenance dose up to 1 year shows that 97% of the patients have sustained suppressed testosterone levels 
(T≤0.5 ng/ml).  
 
In case the patient's clinical response appears to be sub-optimal, it should be confirmed that serum 
testosterone levels are remaining sufficiently suppressed. 



3 
 

Since degarelix does not induce a testosterone surge it is not necessary to add an anti-androgen as surge 
protection at initiation of therapy. 
 
Special populations 
 
Elderly, hepatically or renally impaired patients: 
There is no need to adjust the dose for the elderly or in patients with mild or moderate liver or kidney 
function impairment (see section 5.2). Patients with severe liver or kidney impairment have not been studied 
and caution is therefore warranted (see section 4.4). 
 
Paediatric population 
There is no relevant use of FIRMAGON in children and adolescents in the treatment of adult male patients 
with advanced hormone-dependent prostate cancer.  
 
Method of administration 
 
FIRMAGON must be reconstituted prior to administration. For instructions on reconstitution and 
administration, please see section 6.6. 
 
FIRMAGON is for subcutaneous use ONLY, not to be administered intravenously. 
Intramuscular administration is not recommended as it has not been studied. 
 
FIRMAGON is administered as a subcutaneous injection in the abdominal region. The injection site should 
vary periodically. Injections should be given in areas where the patient will not be exposed to pressure e.g. 
not close to waistband or belt and not close to the ribs.  
 
4.3 Contraindications 
 
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. 
 
4.4 Special warnings and precautions for use 
 
Effect on QT/QTc interval 
 
Long-term androgen deprivation therapy may prolong the QT interval. In the confirmatory study comparing 
FIRMAGON to leuprorelin periodic (monthly) electrocardiograms (ECGs) were performed; both 
therapies showed QT/QTc intervals exceeding 450 msec in approximately 20% of the patients, and 500 msec 
in 1% and 2% of the degarelix and leuprorelin patients, respectively (see section 5.1). 
FIRMAGON has not been studied in patients with a history of a corrected QT interval over 450 msec, in 
patients with a history of or risk factors for torsades de pointes and in patients receiving concomitant 
medicinal products that might prolong the QT interval. Therefore in such patients, the benefit/risk ratio of 
FIRMAGON must be thoroughly appraised (see sections 4.5 and 4.8).  
A thorough QT study showed that there was no intrinsic effect of degarelix on QT/QTc interval (see section 
4.8). 
 
Hepatic impairment 
 
Patients with known or suspected hepatic disorder have not been included in long-term clinical trials with 
degarelix. Mild, transient increases in ALT and AST have been seen, these were not accompanied by a rise 
in bilirubin or clinical symptoms. Monitoring of liver function in patients with known or suspected hepatic 
disorder is advised during treatment. The pharmacokinetics of degarelix has been investigated after single 
intravenous administration in subjects with mild to moderate hepatic impairment (see section 5.2). 
 
Renal impairment 
 
Degarelix has not been studied in patients with severe renal impairment and caution is therefore warranted. 
 



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Hypersensitivity 
 
Degarelix has not been studied in patients with a history of severe untreated asthma, anaphylactic reactions 
or severe urticaria or angioedema. 
 
Changes in bone density 
 
Decreased bone density has been reported in the medical literature in men who have had orchiectomy or who 
have been treated with a GnRH agonist. It can be anticipated that long periods of testosterone suppression in 
men will have effects on bone density. Bone density has not been measured during treatment with degarelix. 
 
Glucose tolerance 
 
A reduction in glucose tolerance has been observed in men who have had orchiectomy or who have been 
treated with a GnRH agonist. Development or aggravation of diabetes may occur; therefore diabetic patients 
may require more frequent monitoring of blood glucose when receiving androgen deprivation therapy. The 
effect of degarelix on insulin and glucose levels has not been studied. 
 
Cardiovascular disease 
 
Cardiovascular disease such as stroke and myocardial infarction has been reported in the medical literature in 
patients with androgen deprivation therapy. Therefore, all cardiovascular risk factors should be taken into 
account. 
 
4.5 Interaction with other medicinal products and other forms of interaction 
 
No formal drug-drug interaction studies have been performed. 
 
Since androgen deprivation treatment may prolong the QTc interval, the concomitant use of degarelix with 
medicinal products known to prolong the QTc interval or medicinal products able to induce torsades de 
pointes such as class IA (e.g. quinidine, disopyramide) or class III (e.g. amiodarone, sotalol, dofetilide, 
ibutilide) antiarrhythmic medicinal products, methadone,  moxifloxacin, antipsychotics, etc. should be 
carefully evaluated (see section 4.4). 
 
Degarelix is not a substrate for the human CYP450 system and has not been shown to induce or inhibit 
CYP1A2, CYP2C8, CYP2C9, CYP2C19, CYP2D6, CYP2E1, or CYP3A4/5 to any great extent in vitro. 
Therefore, clinically significant pharmacokinetic drug-drug interactions in metabolism related to these 
isoenzymes are unlikely. 
 
4.6 Fertility, pregnancy and lactation 
 
Pregnancy and breast-feeding 
 
There is no relevant indication for use of FIRMAGON in women. 
 
Fertility 
 
FIRMAGON may inhibit male fertility as long as the testosterone is suppressed. 
 
4.7 Effects on ability to drive and use machines 
 
FIRMAGON has no or negligible influence on the ability to drive and use machines.  Fatigue and dizziness 
are common adverse reactions that might influence the ability to drive and use machines. 
 
4.8 Undesirable effects 
 
Summary of the safety profile 



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The most commonly observed adverse reactions during degarelix therapy in the confirmatory phase III study 
(N=409) were due to the expected physiological effects of testosterone suppression, including hot flushes 
and weight increase (reported in 25% and 7%, respectively, of patients receiving treatment for one year), or 
injection site adverse reactions. Transient chills, fever or influenza like illness were reported to occur hours 
after dosing (in 3%, 2% and 1% of patients, respectively). 
 
The injection site adverse reactions reported were mainly pain and erythema, reported in 28% and 17% of 
patients, respectively, less frequently reported were swelling (6%), induration (4%) and nodule (3%). These 
events occurred primarily with the starting dose whereas during maintenance therapy with the 80 mg dose, 
the incidence of these events pr 100 injections was: 3 for pain and <1 for erythema, swelling, nodule and 
induration. The reported events were mostly transient, of mild to moderate intensity and led to very few 
discontinuations (<1%). Serious injection site reactions were very rarely reported such as injection site 
infection, injection site abscess or injection site necrosis that could require surgical treatment/drainage. 
 
Tabulated list of adverse reactions 
 
The frequency of undesirable effects listed below is defined using the following convention: 
very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to 
<1/1,000) and very rare (<1/10,000). Within each frequency grouping, undesirable effects are presented in 
order of decreasing seriousness. 
 
Table 1: Frequency of adverse drug reactions reported in 1,259 patients treated for a total of 1781 patient 
years (phase II and III studies) and from post-marketing reports 

MedDRA 
System Organ 
Class (SOC) 

Very common 
 

Common 
 

Uncommon 
 

Rare 

Blood and 
lymphatic 
system disorders 

 Anaemia*  Neutropenic 
fever 

Immune system 
disorders 

  Hypersensitivity Anaphylactic 
reactions 

Metabolism and 
nutrition 
disorders 

 Weight 
increase* 

Hyperglycemia/Diabetes 
mellitus, cholesterol 
increased, weight 
decreased, appetite 
decreased, changes in blood 
calcium 

 

Psychiatric 
disorders 

 Insomnia Depression, libido 
decreased* 

 

Nervous system 
disorders 

 Dizziness, 
headache 

Mental impairment, 
hypoaesthesia  

 

Eye disorders   Vision blurred  
Cardiac 
disorders 

  Cardiac arrhythmia (incl. 
atrial fibrillation), 
palpitations,  
QT prolongation*(see 
sections 4.4 and 4.5) 

Myocardial 
infarction, 
cardiac failure 

Vascular 
disorders 

Hot flush*  Hypertension, vasovagal 
reaction (incl. hypotension) 

 

Respiratory, 
thoracic and 
mediastinal 
disorders 

  Dyspnoea  



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Gastrointestinal 
disorders 

 Diarrhoea, 
nausea 

Constipation, vomiting, 
abdominal pain, abdominal 
discomfort, dry mouth 

 

Hepatobiliary 
disorders 

 Liver 
transamina
ses 
increased 

Bilirubin increased, 
alkaline phosphatase 
increased 

 

Skin and 
subcutaneous 
tissue disorders 

 Hyperhidro
sis (incl. 
night 
sweats)*, 
rash 

Urticaria, skin nodule, 
alopecia, pruritus, erythema 

 

Musculoskeletal
, connective 
tissue and bone 
disorders 

 Musculosk
eletal pain 
and 
discomfort 

Osteoporosis/osteopenia, 
arthralgia muscular 
weakness, muscle spasms, 
joint swelling/stiffness 

Rhabdomyo-
lysis 

Renal and 
urinary 
disorders 

  Pollakiuria, micturition 
urgency, dysuria, nocturia, 
renal impairment, 
incontinence 

 

Reproductive 
system and 
breast disorders 

 Gynaecom
astia*, 
testicular 
atrophy*, 
erectile 
dysfunction
*  

Testicular pain, breast pain, 
pelvic pain, genital 
irritation, ejaculation failure 

 

General 
disorders and 
administration 
site conditions 

Injection site 
adverse 
reactions 

Chills, 
pyrexia, 
fatigue*, 
Influenza-
like illness 

Malaise, peripheral oedema   

*Known physiological consequence of testosterone suppression 
 
Description of selected adverse reactions 
 
Changes in laboratory parameters 
Changes in laboratory values seen during one year of treatment in the confirmatory phase III study (N=409) 
were in the same range for degarelix and a GnRH-agonist (leuprorelin) used as comparator. Markedly 
abnormal (>3*ULN) liver transaminase values (ALT, AST and GGT) were seen in 2-6% of patients with 
normal values prior to treatment, following treatment with both medicinal products. Marked decrease in 
haematological values, hematocrit (≤0.37) and hemoglobin (≤115 g/l) were seen in 40% and 13-15%, 
respectively, of patients with normal values prior to treatment, following treatment with both medicinal 
products. It is unknown to what extent this decrease in haematological values was caused by the underlying 
prostate cancer and to what extent it was a consequence of androgen deprivation therapy. Markedly 
abnormal values of potassium (≥5.8 mmol/l), creatinine (≥177 μmol/l) and BUN (≥10.7 mmol/l) in patients 
with normal values prior to treatment, were seen in 6%, 2% and 15% of degarelix treated patients and 3%, 
2% and 14% of leuprorelin treated patients, respectively. 
 
Changes in ECG measurements 
Changes in ECG measurements seen during one year of treatment in the confirmatory phase III study 
(N=409) were in the same range for degarelix and a GnRH-agonist (leuprorelin) used as comparator. Three 
(<1%) out of 409 patients in the degarelix group and four (2%) out of 201 patients in the leuprorelin 7.5 mg 
group, had a QTcF ≥ 500 msec. From baseline to end of study the median change in QTcF for degarelix was 
12.0 msec and for leuprorelin was 16.7 msec. 
The lack of intrinsic effect of degarelix on cardiac repolarisation (QTcF), heart rate, AV conduction, cardiac 
depolarisation, or T or U wave morphology was confirmed in a thorough QT study in healthy subjects 



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(N=80) receiving an i.v. infusion of degarelix over 60 min, reaching a mean Cmax of 222 ng/mL, approx. 3-4-
fold the Cmax obtained during prostate cancer treatment. 
 
Reporting of suspected adverse reactions 
 
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows 
continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked 
to report any suspected adverse reactions via the national reporting system listed in Appendix V. 
 
4.9 Overdose 
 
There is no clinical experience with the effects of an acute overdose with degarelix. In the event of an 
overdose the patient should be monitored and appropriate supportive treatment should be given, if considered 
necessary.  
 
 
5. PHARMACOLOGICAL PROPERTIES 
 
5.1 Pharmacodynamic properties 
 
Pharmacotherapeutic group: Endocrine therapy, Other hormone antagonists and related agents, ATC code: 
L02BX02  
 
Mechanism of action 
 
Degarelix is a selective gonadotrophin releasing-hormone (GnRH) antagonist that competitively and 
reversibly binds to the pituitary GnRH receptors, thereby rapidly reducing the release of the gonadotrophins, 
luteinizing hormone (LH) and follicle stimulating hormone (FSH), and thereby reducing the secretion of 
testosterone (T) by the testes. Prostatic carcinoma is known to be androgen sensitive and responds to 
treatment that removes the source of androgen. Unlike GnRH agonists, GnRH antagonists do not induce a 
LH surge with subsequent testosterone surge/tumour stimulation and potential symptomatic flare after the 
initiation of treatment. 
 
A single dose of 240 mg degarelix, followed by a monthly maintenance dose of 80 mg, rapidly causes a 
decrease in the concentrations of LH, FSH and subsequently testosterone. The serum concentration of 
dihydrotestosterone (DHT) decreases in a similar manner to testosterone.  
 
Degarelix is effective in achieving and maintaining testosterone suppression well below medical castration 
level of 0.5 ng/ml. Maintenance monthly dosing of 80 mg resulted in sustained testosterone suppression in 
97% of patients for at least one year. No testosterone microsurges were observed after re-injection during 
degarelix treatment. Median testosterone levels after one year of treatment were 0.087 ng/ml (interquartile 
range 0.06-0.15) N=167. 
 
Results of the confirmatory Phase III study 
 
The efficacy and safety of degarelix was evaluated in an open-label, multi-centre, randomised, active 
comparator controlled, parallel-group study. The study investigated the efficacy and safety of two different 
degarelix monthly dosing regimens with a starting dose of 240 mg (40 mg/ml) followed by monthly doses 
subcutaneous administration of 160 mg (40 mg/ml) or 80 mg (20 mg/ml), in comparison to monthly 
intramuscular administration of 7.5 mg leuprorelin in patients with prostate cancer requiring androgen 
deprivation therapy. In total 620 patients were randomised to one of the three treatment groups, of which 504 
(81%) patients completed the study. In the degarelix 240/80 mg treatment group 41 (20%) patients 
discontinued the study, as compared to 32 (16%) patients in the leuprorelin group. 
 
Of the 610 patients treated 
• 31% had localised prostate cancer 
• 29% had locally advanced prostate cancer  

http://www.ema.europa.eu/docs/en_GB/document_library/Template_or_form/2013/03/WC500139752.doc


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• 20% had metastatic prostate cancer  
• 7% had an unknown metastatic status 
• 13% had previous curative intent surgery or radiation and a rising PSA 
 
Baseline demographics were similar between the arms. The median age was 74 years (range 47 to 98 years). 
The primary objective was to demonstrate that degarelix is effective with respect to achieving and 
maintaining testosterone suppression to below 0.5 ng/ml, during 12 months of treatment.  
The lowest effective maintenance dose of 80 mg degarelix was chosen. 
 
Attainment of serum testosterone (T) ≤0.5 ng/ml 
 
FIRMAGON is effective in achieving fast testosterone suppression, see Table 2. 
 
Table 2: Percentage of patients attaining T≤0.5 ng/ml after start of treatment.  

Time Degarelix 240/80 mg Leuprorelin 7.5 mg 

Day 1 52% 0%  

Day 3 96% 0%  

Day 7 99% 1% 

Day 14 100% 18% 

Day 28 100% 100% 
 
Avoidance of testosterone surge 
 
Surge was defined as testosterone exceeding baseline by ≥15% within the first 2 weeks. 
None of the degarelix-treated patients experienced a testosterone surge; there was an average decrease of 
94% in testosterone at day 3. Most of the leuprorelin-treated patients experienced testosterone surge; there 
was an average increase of 65% in testosterone at day 3. This difference was statistically significant 
(p<0.001). 
 
Figure 1: Percentage change in testosterone from baseline by treatment group until day 28 (median with 
interquartile ranges). 
 



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The primary end-point in the study was testosterone suppression rates after one year of treatment with 
degarelix or leuprorelin. The clinical benefit for degarelix compared to leuprorelin plus anti-androgen in the 
initial phase of treatment has not been demonstrated. 
 
Testosterone Reversibility 
 
In a study involving patients with rising PSA after localised therapy (mainly radical prostatectomy and 
radiation) were administered FIRMAGON for seven months followed by a seven months monitoring period. 
The median time to testosterone recovery (>0.5 ng/mL, above castrate level) after discontinuation of 
treatment was 112 days (counted from start of monitoring period, i.e 28 days after last injection). The median 
time to testosterone >1.5 ng/mL (above lower limit of normal range) was 168 days.  
 
Long-term effect 
 
Successful response in the study was defined as attainment of medical castration at day 28 and maintenance 
through day 364 where no single testosterone concentration was greater than 0.5 ng/ml. 
 
Table 3: Cumulative probability of testosterone ≤0.5 ng/ml from Day 28 to Day 364. 

 Degarelix 240/80 mg 
N=207 

Leuprorelin 7.5 mg 
N=201 

No. of responders 202 194 
Response Rate  
(confidence intervals)* 

97.2% 
(93.5; 98.8%) 

96.4% 
(92.5; 98.2%) 

* Kaplan Meier estimates within group 
 
Attainment of prostate specific antigen (PSA) reduction 
 
Tumour size was not measured directly during the clinical trial programme, but there was an indirect 
beneficial tumour response as shown by a 95% reduction after 12 months in median PSA for degarelix.  
 
The median PSA in the study at baseline was: 



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• for the degarelix 240/80 mg treatment group 19.8 ng/ml (interquartile range: P25 9.4 ng/ml, P75 
46.4 ng/ml)  

• for the leuprorelin 7.5 mg treatment group 17.4 ng/ml (interquartile range: P25 8.4 ng/ml, P75 
56.5 ng/ml) 

 
Figure 2: Percentage change in PSA from baseline by treatment group until day 56 (median with interquartile 
ranges). 

 

 
This difference was statistically significant (p<0.001) for the pre-specified analysis at day 14 and day 28. 
 
Prostate specific antigen (PSA) levels are lowered by 64% two weeks after administration of degarelix, 85% 
after one month, 95% after three months, and remained suppressed (approximately 97%) throughout the one 
year of treatment. 
From day 56 to day 364 there were no significant differences between degarelix and the comparator in the 
percentage change from baseline. 
 
Effect on prostate volume 
 
Three months therapy with degarelix (240/80 mg dose regimen) resulted in a 37% reduction in prostate 
volume as measured by trans-rectal ultrasound scan (TRUS) in patients requiring hormonal therapy prior to 
radiotherapy and in patients who were candidates for medical castration. The prostate volume reduction was 
similar to that attained with goserelin plus anti-androgen protection.  
 
Effect on QT/QTc intervals 
 
In the confirmatory study comparing FIRMAGON to leuprorelin periodic electrocardiograms were 
performed. Both therapies showed QT/QTc intervals exceeding 450 msec in approximately 20% of the 
patients. From baseline to end of study the median change for FIRMAGON was 12.0 msec and for 
leuprorelin it was 16.7 msec. 
 
Anti-degarelix antibodies 
 
Anti-degarelix antibody development has been observed in 10% of patients after treatment with 
FIRMAGON for one year and 29% of patients after treatment with FIRMAGON for up to 5.5 years. There is 



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no indication that the efficacy or safety of FIRMAGON treatment is affected by antibody formation after up 
to 5.5 years of treatment.  
 
Paediatric population 
 
The European Medicines Agency has waived the obligation to submit the results of studies with 
FIRMAGON in all subsets of the paediatric population (see section 4.2 for information on paediatric use). 
 
5.2 Pharmacokinetic properties 
 
Absorption 
 
Following subcutaneous administration of 240 mg degarelix at a concentration of 40 mg/ml to prostate 
cancer patients in the pivotal study CS21, AUC0-28 days was 635 (602-668) day*ng/ml, Cmax was 66.0 (61.0-
71.0) ng/ml and occurred at tmax at 40 (37-42) hours. Mean trough values were approximately 11-12 ng/ml 
after the starting dose and 11-16 ng/ml after maintenance dosing of 80 mg at a concentration of 20 mg/ml. 
Cmax degarelix plasma concentration decreases in a biphasic fashion, with a mean terminal half-life (t½) of 29 
days for the maintenance dose. The long half-life after subcutaneous administration is a consequence of a 
very slow release of degarelix from the depot formed at the injection site(s). The pharmacokinetic behavior 
of the medicinal product is influenced by its concentration in the solution for injection. Thus, Cmax and 
bioavailability tend to decrease with increasing dose concentration while the half-life is increased. Therefore, 
no other dose concentrations than the recommended should be used.  
 
Distribution 
 
The distribution volume in healthy elderly men is approximately 1 l/kg. Plasma protein binding is estimated 
to be approximately 90%. 
 
Biotransformation 
 
Degarelix is subject to common peptidic degradation during the passage of the hepato-biliary system and is 
mainly excreted as peptide fragments in the faeces. No significant metabolites were detected in plasma 
samples after subcutaneous administration. In vitro studies have shown that degarelix is not a substrate for 
the human CYP450 system. 
 
Elimination 
 
In healthy men, approximately 20-30% of a single intravenously administered dose is excreted in the urine, 
suggesting that 70-80% is excreted via the hepato-biliary system. The clearance of degarelix when 
administered as single intravenous doses (0.864-49.4 µg/kg) in healthy elderly men was found to be 35-
50 ml/h/kg. 
 
Special populations 
 
Patients with renal impairment 
No pharmacokinetic studies in renally impaired patients have been conducted. Only about 20-30% of a given 
dose of degarelix is excreted unchanged by the kidneys. A population pharmacokinetics analysis of the data 
from the confirmatory Phase III study has demonstrated that the clearance of degarelix in patients with mild 
to moderate renal impairment is reduced by approximately 23%; therefore, dose adjustment in patients with 
mild or moderate renal impairment is not recommended. Data on patients with severe renal impairment is 
scarce and caution is therefore warranted in this patient population.    
 
Patients with hepatic impairment 
Degarelix has been investigated in a pharmacokinetic study in patients with mild to moderate hepatic 
impairment. No signs of increased exposure in the hepatically impaired subjects were observed compared to 
healthy subjects. Dose adjustment is not necessary in patients with mild or moderate hepatic impairment. 



12 
 

Patients with severe hepatic dysfunction have not been studied and caution is therefore warranted in this 
group.  
 
5.3 Preclinical safety data 
 
Animal reproduction studies showed that degarelix caused infertility in male animals. This is due to the 
pharmacological effect; and the effect was reversible. 
 
In female reproduction toxicity studies degarelix revealed findings expected from the pharmacological 
properties. It caused a dosage dependent prolongation of the time to mating and to pregnancy, a reduced 
number of corpora lutea, and an increase in the number of pre- and post-implantation losses, abortions, early 
embryo/foetal deaths, premature deliveries and in the duration of parturition. 
 
Nonclinical studies on safety pharmacology, repeated dose toxicity, genotoxicity, and carcinogenic potential 
revealed no special hazard for humans. Both in vitro and in vivo studies showed no signs of QT prolongation. 
 
No target organ toxicity was observed from acute, subacute and chronic toxicity studies in rats 
and monkeys following subcutaneous administration of degarelix. Drug-related local irritation was noted in 
animals when degarelix was administered subcutaneously in high doses.  
 
 
6. PHARMACEUTICAL PARTICULARS 
 
6.1 List of excipients 
 
Powder 
Mannitol (E421) 
 
Solvent 
Water for injections 
 
6.2 Incompatibilities 
 
In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal 
products. 
 
6.3 Shelf life 
 
3 years. 
 
After reconstitution 
 
Chemical and physical in-use stability has been demonstrated for 2 hours at 25ºC. From a microbiological 
point of view, unless the method of reconstitution precludes the risk of microbial contamination, the product 
should be used immediately. If not used immediately, in-use storage times and conditions are the 
responsibility of the user. 
 
6.4 Special precautions for storage 
 
This medicinal product does not require any special storage conditions. 
For storage conditions of the reconstituted medicinal product, see section 6.3. 
 
6.5 Nature and contents of container 
 
FIRMAGON 80 mg powder and solvent for solution for injection 
 



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Glass (type I) vial with bromobutyl rubber stopper and aluminium flip-off seal containing 80 mg powder for 
solution for injection. 
Pre-filled glass (type I) syringe with elastomer plunger stopper, tip cap and line-marking at 4 ml containing 
4.2 ml solvent. 
Plunger rod. 
Vial adapter. 
Injection needle (25G 0.5 x 25 mm). 
 
FIRMAGON 120 mg powder and solvent for solution for injection 
 
Glass (type I) vial with bromobutyl rubber stopper and aluminium flip-off seal containing 120 mg powder 
for solution for injection. 
Pre-filled glass (type I) syringe with elastomer plunger stopper, tip cap and line-marking at 3 ml containing 
3 ml solvent. 
Plunger rods. 
Vial adapters. 
Injection needles (25G 0.5 x 25 mm). 
 
Pack sizes 
 
FIRMAGON 80 mg powder and solvent for solution for injection 
 
Pack-size of 1 tray containing 1 powder vial, 1 solvent pre-filled syringe, 1 plunger rod, 1 vial adapter and 1 
needle. 
Pack-size of 3 trays containing 3 powder vials, 3 solvent pre-filled syringes, 3 plunger rods, 3 vial adapters 
and 3 needles. 
 
FIRMAGON 120 mg powder and solvent for solution for injection 
 
Pack-size of 2 trays containing 2 powder vials, 2 solvent pre-filled syringes, 2 plunger rods, 2 vial adapters 
and 2 needles. 
 
Not all pack sizes may be marketed. 
 
6.6 Special precautions for disposal and other handling 
 
The instructions for reconstitution must be followed carefully. 
 
Administration of other concentrations is not recommended because the gel depot formation is influenced by 
the concentration. The reconstituted solution should be a clear liquid, free of undissolved matter. 
 
NOTE: THE VIALS SHOULD NOT BE SHAKEN 
 
The pack contains one vial of powder and one pre-filled syringe with solvent that must be prepared for 
subcutaneous injection.  
 

 

1.  Remove the cover from the vial adapter pack. 
Attach the adapter to the powder vial by pressing 
the adapter down until the spike pushes through 
the rubber stopper and the adapter snaps in place. 

2. Prepare the pre-filled syringe by attaching the plunger rod. 



14 
 

 

3. Remove the cap of the pre-filled syringe. Attach 
the syringe to the powder vial by screwing it on 
to the adapter. Transfer all solvent to the 
powder vial. 

 
 

4. With the syringe still attached to the adapter, 
swirl gently until the liquid looks clear and without 
undissolved powder or particles. If the powder 
adheres to the side of the vial above the liquid 
surface, the vial can be tilted slightly. Avoid shaking 
to prevent foam formation. 

 

 A ring of small air bubbles on the surface of the 
liquid is acceptable. The reconstitution procedure 
usually takes a few minutes, but may take up to 15 
minutes in some cases. 

 

 

 

 

 

 

5. Turn the vial upside down and draw up to the line 
mark on the syringe for injection.  

Always make sure to withdraw the precise 
volume and adjust for any air bubbles. 

 
FIRMAGON 80 mg powder and solvent for solution for 
injection: withdrawn until the line marking at 4 ml. 

 

 

 

 
FIRMAGON 120 mg powder and solvent for solution 
for injection: withdrawn until the line marking at 
3 ml. 

 

 

6. Detach the syringe from the vial adapter and attach the needle for deep subcutaneous 
injection to the syringe. 



15 
 

 

7. Perform a deep subcutaneous injection. To do so: 
grasp the skin of the abdomen, elevate the 
subcutaneous tissue and insert the needle deeply at 
an angle of not less than 45 degrees. 

 
FIRMAGON 80 mg powder and solvent for solution for 
injection: Inject 4 ml of FIRMAGON 80 mg slowly, 
immediately after reconstitution. 

 

FIRMAGON 120 mg powder and solvent for solution 
for injection: Inject 3 ml of FIRMAGON 120 mg 
slowly, immediately after reconstitution. 

8. No injections should be given in areas where the patient will be exposed to pressure, e.g. 
around the belt or waistband or close to the ribs. 

 Do not inject directly into a vein. Gently pull back the plunger to check if blood is 
aspirated. If blood appears in the syringe, the medicinal product can no longer be used. 
Discontinue the procedure and discard the syringe and the needle (reconstitute a new dose 
for the patient). 

9. FIRMAGON 120 mg powder and solvent for solution for injection 

 Repeat the reconstitution procedure for the second dose. Choose a different injection site 
and inject 3 ml.  

 
No special requirements for disposal.  
 
 
7. MARKETING AUTHORISATION HOLDER 
 
Ferring Pharmaceuticals A/S 
Kay Fiskers Plads 11 
DK-2300 Copenhagen S 
Denmark 
Tel: +45 88 33 88 34 
 
 
8. MARKETING AUTHORISATION NUMBER(S)  
 
FIRMAGON 80 mg powder and solvent for solution for injection 
 
EU/1/08/504/001 
EU/1/08/504/003 
 
FIRMAGON 120 mg powder and solvent for solution for injection 
 
EU/1/08/504/002 
 
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 
 
Date of first authorisation:17/02/2009 
Date of latest renewal: 19/09/2013 
 
10. DATE OF REVISION OF THE TEXT 
 
 



16 
 

 
Detailed information on this medicinal product is available on the website of the European Medicines 
Agency http://www.ema.europa.eu/. 
 
 

http://www.ema.europa.eu/


18 
 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 ANNEX II 
 

A. MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE 
 
B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND 

USE 
 
C. OTHER CONDITIONS AND REQUIREMENTS OF THE 

MARKETING AUTHORISATION 
 

D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE 
SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT 



19 
 

A. MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE 
 
Name and address of the manufacturer responsible for batch release 
Ferring GmbH 
Wittland 11 
D-24109 Kiel 
Germany 
 
 
B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE 
 
Medicinal product subject to medical prescription. 
 
 
C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION 
 
• Periodic safety update reports (PSURs) 
 
The requirements for submission of PSURs for this medicinal product are set out in the list of Union 
reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any 
subsequent updates published on the European medicines web-portal. 
 
 
D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE 

OF THE MEDICINAL PRODUCT   
 
• Risk management plan (RMP) 

 
The marketing authorisation holder (MAH) shall perform the required pharmacovigilance activities and 
interventions detailed in the agreed RMP presented in Module 1.8.2 of the marketing authorisation and any 
agreed subsequent updates of the RMP. 
 
An updated RMP should be submitted 

• At the request of the European Medicines Agency  
• Whenever the risk management system is modified, especially as the result of new information being 

received that may lead to a significant change to the benefit/risk profile or as the result of an important 
(pharmacovigilance or risk minimisation) milestone being reached. 

 



20 
 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

ANNEX III 
 

LABELLING AND PACKAGE LEAFLET 



21 
 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

A. LABELLING 



22 
 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
CARTON FOR FIRMAGON 80 mg powder and solvent for solution for injection 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
FIRMAGON 80 mg powder and solvent for solution for injection 
degarelix 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each vial contains 80 mg degarelix (as acetate). After reconstitution each ml of the solution contains 20 mg 
degarelix. 
 
 
3. LIST OF EXCIPIENTS 
 
Mannitol (E421), water for injections 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
Powder and solvent for solution for injection 
 
Pack-size of 1 tray containing 
1 vial with 80 mg degarelix (powder) 
1 pre-filled syringe with 4.2 ml solvent 
1 plunger rod 
1 vial adapter 
1 injection needle 
 
Pack-size of 3 trays containing 
3 vials with 80 mg degarelix (powder) 
3 pre-filled syringe with 4.2 ml solvent 
3 plunger rod 
3 vial adapter 
3 injection needle 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Read the package leaflet before use. 
Subcutaneous use only. 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF 

THE SIGHT AND REACH OF CHILDREN 
 
Keep out of the sight and reach of children. 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
 



23 
 

8. EXPIRY DATE 
 
EXP 
 
 
9. SPECIAL STORAGE CONDITIONS 
 
 
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR 

WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 

 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
Ferring Pharmaceuticals A/S 
Kay Fiskers Plads 11 
2300 Copenhagen S 
Denmark 
+45 88 33 88 34 
 
 
12. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/08/504/001    Pack-size of 1 tray  
EU/1/08/504/003    Pack-size of 3 trays 
 
 
13. BATCH NUMBER 
 
Batch 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
Medicinal product subject to medical prescription. 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
Justification for not including Braille accepted. 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
 
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 
PC: 



24 
 

SN: 
NN: 
 



25 
 

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 
 
VIAL FOR FIRMAGON 80 mg powder for solution for injection 
 
 
1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION 
 
FIRMAGON 80 mg powder for injection 
degarelix 
SC use only 
 
 
2. METHOD OF ADMINISTRATION 
 
Read the package leaflet before use. 
 
 
3. EXPIRY DATE 
 
EXP 
 
 
4. BATCH NUMBER 
 
BN 
 
 
5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 
 
80 mg 
 
 
6. OTHER 
 



26 
 

 
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 
 
PRE-FILLED SYRINGE FOR SOLVENT 4.2 ml water for injections 
 
 
1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION 
 
Solvent for FIRMAGON 
 
Water for injections 
 
 
2. METHOD OF ADMINISTRATION 
 
Read the package leaflet before use. 
 
 
3. EXPIRY DATE 
 
EXP 
 
 
4. BATCH NUMBER 
 
BN 
 
 
5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 
 
4.2 ml 
 
 
6. OTHER 
 
 



27 
 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
CARTON FOR FIRMAGON 120 mg powder and solvent for solution for injection 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
FIRMAGON 120 mg powder and solvent for solution for injection 
degarelix 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each vial contains 120 mg degarelix (as acetate). After reconstitution each ml of the solution contains 40 mg 
degarelix. 
 
 
3. LIST OF EXCIPIENTS 
 
Mannitol (E421), water for injections 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
Powder and solvent for solution for injection 
 
Pack-size of 2 trays containing: 
2 vials with 120 mg degarelix (powder)  
2 pre-filled syringes with 3 ml solvent 
2 plunger rods 
2 vial adapters 
2 injection needles 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Read the package leaflet before use. 
Subcutaneous use only. 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF 

THE SIGHT AND REACH OF CHILDREN 
 
Keep out of the sight and reach of children. 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
 
8. EXPIRY DATE 
 
EXP 
 
 
9. SPECIAL STORAGE CONDITIONS 



28 
 

 
 
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR 

WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 

 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
Ferring Pharmaceuticals A/S 
Kay Fiskers Plads 11 
2300 Copenhagen S 
Denmark 
+45 88 33 88 34 
 
 
12. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/08/504/002  
 
 
13. BATCH NUMBER 
 
Batch 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
Medicinal product subject to medical prescription. 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
Justification for not including Braille accepted. 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
 
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 
PC: 
SN: 
NN: 
 



29 
 

 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 
 
VIAL FOR FIRMAGON 120 mg powder for solution for injection 
 
 
1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION 
 
FIRMAGON 120 mg powder for injection 
degarelix 
SC use only 
 
 
2. METHOD OF ADMINISTRATION 
 
Read the package leaflet before use. 
 
 
3. EXPIRY DATE 
 
EXP 
 
 
4. BATCH NUMBER 
 
BN 
 
 
5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 
 
120 mg 
 
 
6. OTHER 
 
 



30 
 

 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 
 
PRE-FILLED SYRINGE FOR SOLVENT 3 ml water for injections 
 
 
1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION 
 
Solvent for FIRMAGON 
Water for injections 
 
 
2. METHOD OF ADMINISTRATION 
 
Read the package leaflet before use. 
 
 
3. EXPIRY DATE 
 
EXP 
 
 
4. BATCH NUMBER 
 
BN 
 
 
5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 
 
3 ml 
 
 
6. OTHER 
 
 



31 
 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

B. PACKAGE LEAFLET 



32 
 

Package leaflet: Information for the user 
 

FIRMAGON 80 mg powder 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. 
− If you get any of the side effects, talk to your doctor. This includes any possible side effects not listed in 

this leaflet. See section 4. 
 
What is in this leaflet:  
 
1. What FIRMAGON is and what it is used for 
2. What you need to know before you use FIRMAGON 
3. How to use FIRMAGON 
4. Possible side effects 
5. How to store FIRMAGON 
6. Contents of the pack and other information 
 
 
1. What FIRMAGON is and what it is used for 
 
FIRMAGON contains degarelix. 
Degarelix is a synthetic hormone blocker used in the treatment of prostate cancer in adult male patients. 
Degarelix mimics a natural hormone (gonadotrophin-relasing hormone, GnRH) and directly blocks its 
effects. By doing so, degarelix immediately reduces the level of the male hormone testosterone that 
stimulates the prostate cancer. 
 
 
2. What you need to know before you use FIRMAGON 
 
Do not use FIRMAGON  
− If you are allergic to degarelix or any of the other ingredients of this medicine (listed in section 6). 
 
Warnings and precautions  
Please tell your doctor if you have any of the following: 
− Any cardiovascular conditions or heart rhythm problems (arrythmia), or are being treated with medicines 

for this condition. The risk of heart rhythm problems may be increased when using FIRMAGON. 
− Diabetes mellitus. Worsening or onset of diabetes may occur. If you have diabetes, you may have to 

measure blood glucose more frequently. 
− Liver disease. Liver function may need to be monitored. 
− Kidney disease. Use of FIRMAGON has not been investigated in patients with severe kidney disease. 
− Osteoporosis or any condition that affects the strenght of your bones. Reduced level of testosterone may 

cause a reduction in bone calcium (thinning of bones).  
− Severe hypersensitivity. 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. 
 
Other medicines and FIRMAGON 



33 
 

FIRMAGON might interfere with some medicines used to treat heart rhythm problems (e.g. quinidine, 
procainamide, amiodarone and sotalol) or other medicines which can have an effect on heart rhythm (e.g. 
methadone (used for pain relief and as part of drug addiction detoxification), moxifloxacin (an antibiotic), 
antipsychotics). 
 
Tell your doctor if you are taking, have recently taken or might take any other medicines, including 
medicines obtained without a prescription. 
 
Driving and using machines 
Tiredness and dizziness are common side effects that may impair your ability to drive and use machines. 
These side effects may be due to the treatment or effects resulting from the underlying disease. 
 
 
3. How to use FIRMAGON 
 
This medicine is usually injected by a nurse or a doctor. 
 
The recommended starting dose is two consecutive injections of 120 mg. After that, you will receive a 
monthly 80 mg injection. The injected liquid forms a gel from which degarelix is released over a period of 
one month. 
 
FIRMAGON must be injected under the skin (subcutaneously) ONLY. FIRMAGON must NOT be given 
into a blood vessel (intravenously). Precautions must be taken to avoid accidental injection into a vein. The 
site of injection is likely to vary within the abdominal region. 
 
If you forget to use FIRMAGON 
If you believe your monthly dose of FIRMAGON has been forgotten, please talk to your doctor. 
If you have any further questions on the use of this medicine, ask your doctor. 
 
 
4. Possible side effects 
 
Like all medicines, this medicine can cause side effects, although not everybody gets them. 
 
A very serious allergic reaction to this medicine is rare. Seek medical advice straight away if you develop a 
severe rash, itching or shortness of breath or difficulty breathing. These could be symptoms of a severe 
allergic reaction. 
 
Very common (may affect more than 1 in 10 people) 
Hot flushes, injection site pain and redness. Side effects at the injection site are most common with the 
starting dose and less common with the maintenance dose. 
 
 
Common (may affect up to 1 in 10 people) 
− injection site swelling, node and hardness 
− chills, fever or influenza-like illness after the injection 
− trouble sleeping, tiredness, dizziness, headache 
− increased weight, nausea, diarrhoea, elevated levels of some liver enzymes 
− excessive sweating (including night sweats), rash  
− anaemia 
− musculoskeletal pain and discomfort  
− reduced size of testicles, breast swelling, impotence 
 
Uncommon (may affect up to 1 in 100 people) 
− loss of sexual desire, testicular pain, pelvic pain, ejaculation failure, genital irritation, breast pain  
− depression, mental impairment 



34 
 

− skin redness, loss of hair, skin nodule, 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, decreased weight 
− high blood pressure, changes in heart rhythm, changes in ECG (QT-prolongation), feeling of abnormal 

heart beat, dyspnoea, peripheral oedema 
− muscular weakness, muscle spasms, joint swelling/stiffness, osteoporosis/osteopenia, pain in the joint 
− frequent urination, urinary urgency (must hurry to pass urine), difficult or painful urination, urination at 

night, impaired renal function, incontinence 
− blurred vision 
− discomfort at injection including decreased blood pressure and heart rate (vasovagal reaction) 
− malaise 
 
Rare (may affect up to 1 in 1,000 people) 
− febrile neutropenia (very low number of white blood cell in combination with fever), heart attack, heart 

failure 
− unexplained muscular pain or cramps, tenderness, or weakness. The muscle problems can be serious, 

including muscle breakdown resulting in kidney damage. 
 
Very rare (may affect up to 1 in 10,000 people) 
− injection site infection, abscess and necrosis 
 
Reporting of side effects 
If you get any of the side effects, talk to your doctor. 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 Appendix V. By 
reporting side effects you can help provide more information on the safety of this medicine. 
 
 
5. How to store FIRMAGON 
 
Keep this medicine 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 outer packaging. The 
expiry date refers to the last day of that month. 
 
This medicine does not require any special storage conditions. 
 
After reconstitution: 
This medicine is stable for 2 hours at 25ºC.  
Due to the risk of microbial contamination, this medicine should be used immediately. If not used 
immediately, the use of this medicine are the responsibility of the user. 
 
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw 
away medicines you no longer use. These measures will help protect the environment. 
 
 
6. Contents of the pack and other information 
 
What FIRMAGON contains 
− The active substance is degarelix, each vial contains 80 mg degarelix (as acetate). After reconstitution 

1 ml of the reconstituted solution contains 20 mg degarelix. 
− The other ingredient of the powder is mannitol (E 421).  
− The solvent is water for injections. 
 
What FIRMAGON looks like and contents of the pack 

http://www.ema.europa.eu/docs/en_GB/document_library/Template_or_form/2013/03/WC500139752.doc


35 
 

FIRMAGON is a powder and solvent for solution for injection. The powder is white to off-white. The 
solvent is a clear, colourless solution. 
 
FIRMAGON is available in 2 pack-sizes. 
 
Pack-size of 1 tray containing: 
1 vial with powder containing 80 mg of degarelix and 1 pre-filled syringe with 4.2 ml of solvent. 
1 plunger rod, 1 vial adapter and 1 injection needle. 
 
Pack-size of 3 trays containing: 
3 vials with powder containing 80 mg of degarelix and 3 pre-filled syringes with 4.2 ml of solvent. 
3 plunger rods, 3 vial adapters and 3 injection needles. 
 
Not all pack sizes may be marketed. 
 
Marketing Authorisation Holder  
Ferring Pharmaceuticals A/S  
Kay Fiskers Plads 11 
DK-2300 Copenhagen S 
Denmark 
Tel. +45 8833 8834 
 
Manufacturer  
Ferring GmbH 
Wittland 11 
D-24109 Kiel 
Germany 
 
For any information about this medicine, please contact the local representative of the Marketing 
Authorisation Holder: 
 
België/Belgique/Belgien 
Ferring N.V. 
Tel/Tél: +32 53 72 92 00 
ferringnvsa@ferring.be  
 

Lietuva 
CentralPharma Communication UAB 
Tel: +370 5 243 0444 
centralpharma@centralpharma.lt 

България 
Аквaxим АД 
Тел: +359 2 807 5022 
aquachim@aquachim.bg 
 

Luxembourg/Luxemburg 
Ferring N.V.  
Belgique/Belgien  
Tel/Tél: +32 53 72 92 00  
ferringnvsa@ferring.be  
 

Česká republika 
Ferring Pharmaceuticals CZ s.r.o.  
Tel: +420 234 701 333 
cz1-info@ferring.com 
 

Magyarország 
Ferring Magyarország Gyógyszerkereskedelmi Kft. 
Tel: +36 1 236 3800 
ferring@ferring.hu  
 

Danmark 
Ferring Lægemidler A/S 
Tlf: +45 88 16 88 17 
 

Malta 
E.J. Busuttil Ltd. 
Tel: +356 21447184 
info@ejbusuttil.com 
 

Deutschland 
Ferring Arzneimittel GmbH 
Tel: +49 431 5852 0 
info-service@ferring.de  

Nederland 
Ferring B.V. 
Tel: +31 235680300 
infoNL@ferring.com 
 



36 
 

Eesti 
CentralPharma Communication OÜ  
Tel: +372 601 5540 
centralpharma@centralpharma.ee 

Norge 
Ferring Legemidler AS 
Tlf: +47 22 02 08 80 
mail@oslo.ferring.com 
 

Ελλάδα 
Ferring Ελλάς MEΠΕ 
Τηλ: +30 210 68 43 449  
 

Österreich 
Ferring Arzneimittel Ges.m.b.H. 
Tel: +43 1 60 8080 
office@ferring.at  
 

España 
Ferring S.A.U. 
Tel: +34 91 387 70 00 
registros@ferring.com 
 

Polska 
Ferring Pharmaceuticals Poland Sp. z o.o. 
Tel: +48 22 246 06 80 
ferring@ferring.pl 

France 
Ferring S.A.S. 
Tél: +33 1 49 08 67 60 
information.medicale@ferring.com 
 

Portugal 
Ferring Portuguesa – Produtos Farmacêuticos, 
Sociedade Unipessoal, Lda. 
Tel: +351 21 940 51 90 
geral@ferring.com 
 

Hrvatska 
Clinres farmacija d.o.o. 
Tel: +385 1 2396 900 
info@clinres-farmacija.hr 
 
 

România 
Ferring Pharmaceuticals Romania SRL  
Tel: +40 356 113 270 
 

Ireland 
Ferring Ireland Ltd. 
Tel: +353 1 4637355 
enquiries.ireland@ferring.com 

Slovenija 
SALUS, Veletrgovina, d.o.o. 
Tel: +386 1 5899 179 
regulatory@salus.si  
 

Ísland 
Vistor hf. 
Sími: +354 535 70 00 

Slovenská republika 
Ferring Slovakia s.r.o.  
Tel: +421 2 54 416 010 
SK0-Recepcia@ferring.com 

 
Italia 
Ferring S.p.A. 
Tel: +39 02 640 00 11 

 
Suomi/Finland 
Ferring Lääkkeet Oy 
Puh/Tel: +358 207 401 440 
info@ferring.fi 
 

Κύπρος 
A. Potamitis Medicare Ltd 
Τηλ: +357 22583333 
a.potamitismedicare@cytanet.com.cy 

Sverige 
Ferring Läkemedel AB 
Tel: +46 40 691 69 00 
info@ferring.se  
 

Latvija 
CentralPharma Communication SIA 
Tālr: +371 674 50497 
centralpharma@centralpharma.lv 

United Kingdom 
Ferring Pharmaceuticals Ltd. 
Tel: +44 844 931 0050 
contact2@ferring.com  

 
 
This leaflet was last revised in . 
 
Detailed information on this medicine is available on the European Medicines Agency web site: 
http://www.ema.europa.eu/. 

http://www.ema.europa.eu/


37 
 

 
 
 
--------------------------------------------------------------------------------------------------------------------------- 
 
The following information is intended for healthcare professionals only: 
 
Instructions for proper use 
 
NOTE:  
• DO NOT SHAKE THE VIALS 
 
The pack contains one vial of powder and one pre-filled syringe with solvent that must be prepared for 
subcutaneous injection.  
 

 

1.  Remove the cover from the vial adapter pack. 
Attach the adapter to the powder vial by pressing 
the adapter down until the spike pushes through 
the rubber stopper and the adapter snaps in place. 

2. Prepare the pre-filled syringe by attaching the plunger rod. 

 

3. Remove the cap of the pre-filled syringe. Attach 
the syringe to the powder vial by screwing it on 
to the adapter. Transfer all solvent to the 
powder vial. 

 

4. With the syringe still attached to the adapter, swirl 
gently until the liquid looks clear and without 
undissolved powder or particles. If the powder 
adheres to the side of the vial above the liquid 
surface, the vial can be tilted slightly. Avoid shaking 
to prevent foam formation. 

 A ring of small air bubbles on the surface of the 
liquid is acceptable. The reconstitution procedure 
usually takes a few minutes, but  may take up to 15 
minutes in some cases. 

 

5. Turn the vial upside down and draw up to the line 
mark on the syringe for injection.  

Always make sure to withdraw the precise 
volume and adjust for any air bubbles.  

 

6. Detach the syringe from the vial adapter and attach the needle for deep subcutaneous 
injection to the syringe. 



38 
 

 

7. Perform a deep subcutaneous injection. To do so: 
grasp the skin of the abdomen, elevate the 
subcutaneous tissue and insert the needle deeply at 
an angle of not less than 45 degrees.  

Inject 4 ml of FIRMAGON 80 mg slowly, 
immediately after reconstitution.* 

8. No injections should be given in areas where the patient will be exposed to pressure, e.g. 
around the belt or waistband or close to the ribs. 

 Do not inject directly into a vein. Gently pull back the plunger to check if blood is 
aspirated. If blood appears in the syringe, the medicinal product can no longer be used. 
Discontinue the procedure and discard the syringe and the needle (reconstitute a new dose 
for the patient). 

 
* Chemical and physical in-use stability has been demonstrated for 2 hours at 25ºC. From a 

microbiological point of view, unless the method of reconstitution precludes the risk of microbial 
contamination, the product should be used immediately. If not used immediately, in-use storage times 
and conditions are the responsibility of the user. 

 



39 
 

Package leaflet: Information for the user 
 

FIRMAGON 120 mg powder 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. 
− If you get any of the side effects, talk to your doctor. This includes any possible side effects not listed 

in this leaflet. See section 4. 
 
What is in this leaflet:  
 
1. What FIRMAGON is and what it is used for 
2. What you need to know before you use FIRMAGON 
3. How to use FIRMAGON 
4. Possible side effects 
5. How to store FIRMAGON 
6. Contents of the pack and other information 
 
 
1. What FIRMAGON is and what it is used for 
 
FIRMAGON contains degarelix. 
Degarelix is a synthetic hormone blocker used in the treatment of prostate cancer in adult male patients. 
Degarelix mimics a natural hormone (gonadotrophin-relasing hormone, GnRH) and directly blocks its 
effects. By doing so, degarelix immediately reduces the level of the male hormone testosterone that 
stimulates the prostate cancer. 
 
 
2. What you need to know before you use FIRMAGON 
 
Do not use FIRMAGON 
− If you are allergic to degarelix or any of the other ingredients  this medicine (listed in section 6). 
 
Warnings and precautions  
Please tell your doctor if you have any of the following: 
− Any cardiovascular conditions or heart rhythm problems (arrythmia), or are being treated with medicines 

for this condition. The risk of heart rhythm problems may be increased when using FIRMAGON. 
− Diabetes mellitus. Worsening or onset of diabetes may occur. If you have diabetes, you may have to 

measure blood glucose more frequently. 
− Liver disease. Liver function may need to be monitored. 
− Kidney disease. Use of FIRMAGON has not been investigated in patients with severe kidney disease. 
− Osteoporosis or any condition that affects the strenght of your bones. Reduced level of testosterone may 

cause a reduction in bone calcium (thinning of bones). Severe hypersensitivity. 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. 
 
Other medicines and FIRMAGON 
FIRMAGON might interfere with some medicines used to treat heart rhythm problems (e.g. quinidine, 
procainamide, amiodarone and sotalol) or other medicines which can have an effect on heart rhythm (e.g. 



40 
 

methadone (used for pain relief and part of drug addiction detoxification), moxifloxacin (an antibiotic), 
antipsychotics ). 
 
Tell your doctor if you are taking, have recently taken or might take any other medicines, including 
medicines obtained without a prescription. 
 
Driving and using machines 
Tiredness and dizziness are common side effects that may impair your ability to drive and use machines. 
These side effects may be due to the treatment or effects resulting from the underlying disease. 
 
 
3. How to use FIRMAGON 
 
This medicine is usually injected by a nurse or a doctor. 
 
The recommended starting dose is two consecutive injections of 120 mg After that, you will receive a 
monthly 80 mg injection. The injected liquid forms a gel from which degarelix is released over a period of 
one month. 
 
FIRMAGON must be injected under the skin (subcutaneously) ONLY. FIRMAGON must NOT be given 
into a blood vessel (intravenously). Precautions must be taken to avoid accidental injection into a vein. The 
site of injection is likely to vary within the abdominal region. 
 
If you forget to use FIRMAGON 
If you believe your monthly dose of FIRMAGON has been forgotten, please talk to your doctor. 
If you have any further questions on the use of this medicine, ask your doctor. 
 
 
4. Possible side effects 
 
Like all medicines, this medicine can cause side effects, although not everybody gets them. 
 
A very serious allergic reaction to this medicine is rare. Seek medical advice straight away if you develop a 
severe rash, itching or shortness of breath or difficulty breathing. These could be symptoms of a severe 
allergic reaction. 
 
Very common (may affect more than 1 in 10 people) 
Hot flushes, injection site pain and redness. Side effects at the injection site are most common with the 
starting dose and less common with the maintenance dose. 
 
Common (may affect up to 1 in 10 people) 
− injection site swelling, node and hardness 
− chills, fever or influenza-like illness after the injection 
− trouble sleeping, tiredness, dizziness, headache 
− increased weight, nausea, diarrhoea, elevated levels of some liver enzymes 
− excessive sweating (including night sweats), rash  
− anaemia  
− musculoskeletal pain and discomfort 
− reduced size of testicles, breast swelling, impotence 
 
Uncommon (may affect up to 1 in 100 people) 
− loss of sexual desire, testicular pain, pelvic pain, ejaculation failure, genital irritation, breast pain 
− depression, mental impairment 
− skin redness, loss of hair, skin nodule, numbness 
− allergic reactions, hives, itching 



41 
 

− decreased appetite, constipation, vomiting, dry mouth, abdominal pain and discomfort, increased blood 
sugar/diabetes mellitus, increased cholesterol, changes in blood calcium, decreased weight 

− high blood pressure, changes in heart rhythm, changes in ECG (QT-prolongation), feeling of abnormal 
heart beat, dyspnoea, peripheral oedema 

− muscular weakness, muscle spasms, joint swelling/stiffness, osteoporosis/osteopenia, pain in the joint 
− frequent urination, urinary urgency (must hurry to pass urine), difficult or painful urination, urination at 

night, impaired renal function, incontinence 
− blurred vision 
− discomfort at injection including decreased blood pressure and heart rate (vasovagal reaction) 
− malaise 
 
Rare (may affect up to 1 in 1,000 people) 
− febrile neutropenia (very low number of white blood cell in combination with fever), heart attack, heart 

failure 
− unexplained muscular pain or cramps, tenderness, or weakness. The muscle problems can be serious, 

including muscle breakdown resulting in kidney damage. 
 
Very rare (may affect up to 1 in 10,000 people) 
− injection site infection, abscess and necrosis 
 
Reporting of side effects 
If you get any of the side effects, talk to your doctor. 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 Appendix V. By 
reporting side effects you can help provide more information on the safety of this medicine. 
 
 
5. How to store FIRMAGON 
 
Keep this medicine 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 outer packaging. The 
expiry date refers to the last day of that month. 
 
This medicine does not require any special storage conditions. 
 
After reconstitution 
This medicine is stable for 2 hours at 25ºC.  
Due to the risk of microbial contamination, this medicine should be used immediately. If not used 
immediately, the use of this medicine are the responsibility of the user. 
 
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw 
away medicines you no longer use. These measures will help protect the environment. 
 
 
6. Contents of the pack and other information 
 
What FIRMAGON contains 
 
− The active substance is degarelix. Each vial contains 120 mg degarelix (as acetate). After reconstitution 

1 ml of the reconstituted solution contains 40 mg degarelix. 
− The other ingredient of the powder is mannitol (E 421).  
− The solvent is water for injections. 
 
What FIRMAGON looks like and contents of the pack 
 

http://www.ema.europa.eu/docs/en_GB/document_library/Template_or_form/2013/03/WC500139752.doc


42 
 

FIRMAGON is a powder and solvent for solution for injection. The powder is white to off-white. The 
solvent is a clear, colourless solution. 
 
Pack-size of 2 trays containing: 
2 vials with powder containing 120 mg of degarelix and 2 pre-filled syringes with 3 ml of solvent. 
2 plunger rods, 2 vial adapters and 2 injection needles. 
 
Marketing Authorisation Holder 
Ferring Pharmaceuticals A/S  
Kay Fiskers Plads 11 
DK-2300 Copenhagen S 
Denmark 
Tel. +45 8833 8834 
 
Manufacturer 
Ferring GmbH 
Wittland 11 
D-24109 Kiel 
Germany 
 
For any information about this medicine, please contact the local representative of the Marketing 
Authorisation Holder: 
 
België/Belgique/Belgien 
Ferring N.V. 
Tel/Tél: +32 53 72 92 00 
ferringnvsa@ferring.be  
 

Lietuva 
CentralPharma Communication UAB 
Tel: +370 5 243 0444 
centralpharma@centralpharma.lt 

България 
Аквaxим АД 
Тел: +359 2 807 5022 
aquachim@aquachim.bg 
 

Luxembourg/Luxemburg 
Ferring N.V.  
Belgique/Belgien  
Tel/Tél: +32 53 72 92 00 
ferringnvsa@ferring.be  
 

Česká republika 
Ferring Pharmaceuticals CZ s.r.o.  
Tel: +420 234 701 333 
cz1-info@ferring.com 
 

Magyarország 
Ferring Magyarország Gyógyszerkereskedelmi Kft. 
Tel: +36 1 236 3800 
ferring@ferring.hu  
 

Danmark 
Ferring Lægemidler A/S 
Tlf: +45 88 16 88 17 
 

Malta 
E.J. Busuttil Ltd. 
Tel: +356 21447184 
info@ejbusuttil.com 
 

Deutschland 
Ferring Arzneimittel GmbH 
Tel: +49 431 5852 0 
info-service@ferring.de  

Nederland 
Ferring B.V. 
Tel: +31 235680300 
infoNL@ferring.com 
 

Eesti 
CentralPharma Communication OÜ 
Tel: +372 601 5540 
centralpharma@centralpharma.ee 

Norge 
Ferring Legemidler AS 
Tlf: +47 22 02 08 80 
mail@oslo.ferring.com 
 

Ελλάδα 
Ferring Ελλάς MEΠΕ 
Τηλ: +30 210 68 43 449  

Österreich 
Ferring Arzneimittel Ges.m.b.H. 
Tel: +43 1 60 8080 

mailto:aquachim@aquachim.bg


43 
 

 office@ferring.at  
 

España 
Ferring S.A.U. 
Tel: +34 91 387 70 00 
registros@ferring.com 
 

Polska 
Ferring Pharmaceuticals Poland Sp. z o.o. 
Tel: +48 22 246 06 80 
ferring@ferring.pl 

France 
Ferring S.A.S. 
Tél: +33 1 49 08 67 60 
information.medicale@ferring.com 
 

Portugal 
Ferring Portuguesa – Produtos Farmacêuticos, 
Sociedade Unipessoal, Lda. 
Tel: +351 21 940 51 90 
geral@ferring.com 
 

Hrvatska 
Clinres farmacija d.o.o. 
Tel: +385 1 2396 900 
info@clinres-farmacija.hr 
 
 

România 
Ferring Pharmaceuticals Romania SRL  
Tel: +40 356 113 270 
 

Ireland 
Ferring Ireland Ltd. 
Tel: +353 1 4637355 
enquiries.ireland@ferring.com 

Slovenija 
SALUS, Veletrgovina, d.o.o. 
Tel: +386 1 5899 179 
regulatory@salus.si  
 

Ísland 
Vistor hf. 
Sími: +354 535 70 00 

Slovenská republika 
Ferring Slovakia s.r.o.  
Tel: +421 2 54 416 010 
SK0-Recepcia@ferring.com 

 
Italia 
Ferring S.p.A. 
Tel: +39 02 640 00 11 

 
Suomi/Finland 
Ferring Lääkkeet Oy 
Puh/Tel: +358 207 401 440 
info@ferring.fi 
 

Κύπρος 
A. Potamitis Medicare Ltd 
Τηλ: +357 22583333 
a.potamitismedicare@cytanet.com.cy 

Sverige 
Ferring Läkemedel AB 
Tel: +46 40 691 69 00 
info@ferring.se  
 

Latvija 
CentralPharma Communication SIA 
Tālr: +371 674 50497 
centralpharma@centralpharma.lv 

United Kingdom 
Ferring Pharmaceuticals Ltd. 
Tel: +44 844 931 0050 
contact2@ferring.com  

 
 
This leaflet was last revised in . 
 
Detailed information on this medicine is available on the European Medicines Agency web site: 
http://www.ema.europa.eu/. 
 
 
--------------------------------------------------------------------------------------------------------------------------- 
 
The following information is intended for healthcare professionals only: 
 
Instructions for proper use 
 

http://www.ema.europa.eu/


44 
 

NOTE:  
• DO NOT SHAKE THE VIALS 
 
The pack contains two vials of powder and two pre-filled syringes with solvent that must be prepared for 
subcutaneous injection. Hence, the procedure described below need to be repeated a second time. 
 

 

1.  Remove the cover from the vial adapter pack. 
Attach the adapters to the powder vial by 
pressing the adapter down until the spike 
pushes through the rubber stopper and the 
adapter snaps in place. 

2. Prepare the pre-filled syringe by attaching the plunger rod. 

 

3. Remove the cap of the pre-filled syringe. Attach 
the syringe to the powder vial by screwing it on 
to the adapter. Transfer all solvent to the 
powder vial. 

 

4. With the syringe still attached to the adapter, 
swirl gently until the liquid looks clear and without 
undissolved powder or particles. If the powder 
adheres to the side of the vial above the liquid 
surface, the vial can be tilted slightly. Avoid 
shaking to prevent foam formation. 

A ring of small air bubbles on the surface of the 
liquid is acceptable. The reconstitution procedure 
usually takes a few minutes, but may take up to 15 
minutes in some cases. 

 

5. Turn the vial upside down and draw up to the line 
mark of the syringe for injection. 

Always make sure to withdraw the precise 
volume and adjust for any air bubbles. 

 

6. Detach the syringe from the vial adapter and attach the needle for deep subcutaneous 
injection to the syringe. 

 

7. Perform a deep subcutaneous injection. To do so: 
grasp the skin of the abdomen, elevate the 
subcutaneous tissue and insert the needle deeply at 
an angle of not less than 45 degrees.  

 Inject 3 ml of FIRMAGON 120 mg slowly, 
immediately after reconstitution.* 



45 
 

8. No injections should be given in areas where the patient will be exposed to pressure, e.g. 
around the belt or waistband or close to the ribs. 

 Do not inject directly into a vein. Gently pull back the plunger to check if blood is 
aspirated. If blood appears in the syringe, the medicinal product can no longer be used. 
Discontinue the procedure and discard the syringe and the needle (reconstitute a new dose 
for the patient). 

9. Repeat the reconstitution procedure for the second dose. Choose a different injection site 
and inject 3 ml.  

 
* Chemical and physical in-use stability has been demonstrated for 2 hours at 25ºC. From a 

microbiological point of view, unless the method of reconstitution precludes the risk of microbial 
contamination, the product should be used immediately. If not used immediately, in-use storage times 
and conditions are the responsibility of the user. 

 
 
 

 
 


	SUMMARY OF PRODUCT CHARACTERISTICS
	A. MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
	B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE
	C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION
	D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT  
	A. LABELLING
	B. PACKAGE LEAFLET