Wirkstoffe & Arzneimittelsicherheit

Nebenwirkungen · Signifor

Signifor 10 mg powder and solvent for suspension for injection Signifor 20 mg powder and solvent for suspension for injection Signifor 30 mg powder and solvent for suspension for injection Signifor 40 mg powder and solvent for suspension for injection Signifor 60 mg powder and solvent for suspension for injection · Abschnitt 4.8 · PDF-Seite 25

HOS-213468 · Präparat HOS-155106

QT prolongation In the acromegaly study C2305, the proportion of patients with newly occurring notable QT/QTc intervals was comparable between pasireotide intramuscular use and octreotide intramuscular use groups up to crossover, with few notable outlying values. QTcF >480 ms was reported for 3 versus 2 patients in the pasireotide intramuscular use and octreotide intramuscular use groups, respectively, and QTcF >60 ms prolonged from baseline was reported for 2 versus 1 patients in the respective groups. In study C2402, the only notable outlier was a QTcF value >480 ms in 1 patient in the pasireotide intramuscular use 40 mg group. In the Cushing’s disease study G2304, a QTcF value >480 ms was reported for 2 patients. No QTcF values >500 ms were observed in any of the pivotal studies.

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