Nebenwirkungen · Firmagon
FIRMAGON 80 mg powder and solvent for solution for injection FIRMAGON 120 mg powder and solvent for solution for injection · Abschnitt 4.8 · PDF-Seite 6–7
HOS-120813 · Präparat HOS-095217
6 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 (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.
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Version 2022-03-30T02:00:00Z · SHA-256 30eb95905f2a85834a14ebb60e9d230d12617fcceb70d78d157d98caee89b918 · Passage 155e5320b986201a0e280459c00229b02692b0015bab90b6971634bfecdedf98 · Zeichen 7687–8552 im Abschnitt