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 increased weight (reported in 25% and 7%, respectively, of patients receiving treatment for 1 year), or injection site adverse events. 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 events 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 per 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%).
The frequency of undesirable effects listed as follows is defined using the following convention: Very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1000 to <1/100). Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness (see Table 3).
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The following events have been reported as being related to treatment in single patients: Febrile neutropenia, myocardial infarction and congestive heart failure.
Changes in Laboratory Parameters: Changes in laboratory values seen during 1 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 x 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 micromol/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 1 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 4 (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 msec and for leuprorelin was 16.7 msec.