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Firmagon (Degarelix Acetate) - Side Effects and Adverse Reactions

 
 



ADVERSE REACTIONS

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

A total of 1325 patients with prostate cancer received FIRMAGON either as a monthly treatment (60-160 mg) or as a single dose (up to 320 mg).  A total of 1032 patients (78%) were treated for at least 6 months and 853 patients (64%) were treated for one year or more.  The most commonly observed adverse reactions during FIRMAGON therapy included injection site reactions (e.g., pain, erythema, swelling, or induration), hot flashes, increased weight, fatigue, and increases in serum levels of transaminases and gamma-glutamyltransferase (GGT). The majority of the adverse reactions were Grade 1 or 2, with Grade 3/4 adverse reaction incidences of 1% or less.

FIRMAGON was studied in an active-controlled trial (N = 610) in which patients with prostate cancer were randomized to receive FIRMAGON (subcutaneous) or leuprolide (intramuscular) monthly for 12 months. Adverse reactions reported in 5% of patients or more are shown in Table 1.

Table 1. Adverse Reactions Reported in ≥ 5% of Patients in an Active Controlled Study 
  FIRMAGON
240/160 mg
(subcutaneous)
N = 202
FIRMAGON
240/80 mg
(subcutaneous)
N = 207
Leuprolide
7.5 mg
(intramuscular)
N = 201
Percentage of subjects with
adverse events
83% 79% 78%
Body as a whole      
Injection site adverse events 44% 35% <1%
Weight increase 11% 9% 12%
Fatigue 6% 3% 6%
Chills 4% 5% 0%
Cardiovascular system      
Hot flash 26% 26% 21%
Hypertension 7% 6% 4%
Musculoskeletal system      
Back pain 6% 6% 8%
Arthralgia 4% 5% 9%
Urogenital system      
Urinary tract infection 2% 5% 9%
Digestive system      
Increases in Transaminases
and GGT
10% 10% 5%
Constipation 3% 5% 5%

The most frequently reported adverse reactions at the injection sites were pain (28%), erythema (17%), swelling (6%), induration (4%) and nodule (3%). These adverse reactions were mostly transient, of mild to moderate intensity, occurred primarily with the starting dose and led to few discontinuations (<1%).  Grade 3 injection site reactions occurred in 2% or less of patients receiving degarelix.

Hepatic laboratory abnormalities were primarily Grade 1 or 2 and were generally reversible. Grade 3 hepatic laboratory abnormalities occurred in less than 1% of patients.

In 1-5% of patients the following adverse reactions, not already listed, were considered related to FIRMAGON by the investigator:

Body as a whole: Asthenia, fever, night sweats; Digestive system: Nausea; Nervous system: Dizziness, headache, insomnia.

The following adverse reactions, not already listed, were reported to be drug-related by the investigator in ≥1% of patients: erectile dysfunction, gynecomastia, hyperhidrosis, testicular atrophy, and diarrhea.

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 medical castration in men will result in decreased bone density.

Anti-degarelix antibody development has been observed in 10% of patients after treatment with FIRMAGON for 1 year. There is no indication that the efficacy or safety of FIRMAGON treatment is affected by antibody formation.



REPORTS OF SUSPECTED FIRMAGON SIDE EFFECTS / ADVERSE REACTIONS

Below is a sample of reports where side effects / adverse reactions may be related to Firmagon. The information is not vetted and should not be considered as verified clinical evidence.

Possible Firmagon side effects / adverse reactions in 78 year old male

Reported by a health professional (non-physician/pharmacist) from Austria on 2011-11-21

Patient: 78 year old male

Reactions: Fatigue, Palpitations, Nausea

Adverse event resulted in: hospitalization

Suspect drug(s):
Firmagon
    Dosage: (240 mg 1x subcutaneous), (80 mg 1x/month subcutaneous)
    Indication: Prostate Cancer
    Start date: 2011-08-01
    End date: 2011-08-01

Firmagon
    Dosage: (240 mg 1x subcutaneous), (80 mg 1x/month subcutaneous)
    Indication: Prostate Cancer
    Start date: 2011-09-01



Possible Firmagon side effects / adverse reactions in 70 year old male

Reported by a health professional (non-physician/pharmacist) from Germany on 2011-12-09

Patient: 70 year old male weighing 72.0 kg (158.4 pounds)

Reactions: Interstitial Lung Disease

Adverse event resulted in: hospitalization

Suspect drug(s):
Firmagon
    Dosage: (240 mg 1 x subcutaneous) , (80 mg 1x/month)
    Indication: Prostate Cancer Metastatic
    Start date: 2010-12-01
    End date: 2010-12-01

Docetaxel
    Dosage: (75 mg/m2 milligram/sq)
    Indication: Prostate Cancer
    Start date: 2011-01-12
    End date: 2011-02-23

Other drugs received by patient: Prednisolone /00016201/



Possible Firmagon side effects / adverse reactions in 80 year old male

Reported by a health professional (non-physician/pharmacist) from United States on 2012-01-24

Patient: 80 year old male weighing 101.6 kg (223.5 pounds)

Reactions: Injection Site Discomfort, Injection Site Erythema, Prostatic Specific Antigen Increased, Injection Site Paraesthesia, Injection Site Pain

Suspect drug(s):
Firmagon

Other drugs received by patient: Lisinopril; Byetta; Glimepiride; Simvastatin; Metformin HCL



See index of all Firmagon side effect reports >>

Drug label data at the top of this Page last updated: 2012-09-20

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