Wirkstoffe & Arzneimittelsicherheit

Nebenwirkungen · Signifor

Signifor 0.3 mg solution for injection Signifor 0.6 mg solution for injection Signifor 0.9 mg solution for injection · Abschnitt 4.8 · PDF-Seite 9

HOS-213434 · Präparat HOS-155106

Glucose metabolism disorders Elevated glucose was the most frequently reported Grade 3 laboratory abnormality (23.2% of patients) in the phase III study in Cushing’s disease patients. Mean HbA1c increases were less pronounced in patients with normal glycaemia (n=62 overall) at study entry (i.e. 5.29% and 5.22% at baseline and 6.50% and 6.75% at month 6 for the 0.6 and 0.9 mg twice daily dose groups, respectively) relative to pre-diabetic patients (i.e. n=38 overall; 5.77% and 5.71% at baseline and 7.45% and 7.13% at month 6) or diabetic patients (i.e. n=54 overall; 6.50% and 6.42% at baseline and 7.95% and 8.30% at month 6). Mean fasting plasma glucose levels commonly increased within the first month of treatment, with decreases and stabilisation observed in subsequent months. Fasting plasma glucose and HbA1c values generally decreased over the 28 days following pasireotide discontinuation but remained above baseline values. Long-term follow-up data are not available. Patients with baseline HbA1c ≥7% or who were taking antidiabetic medicinal products prior to randomisation tended to have higher mean changes in fasting plasma glucose and HbA1c relative to other patients. Adverse reactions of hyperglycaemia and diabetes mellitus led to study discontinuation in 5 (3.1%) and 4 (2.5%) patients, respectively. One case of ketosis and one case of ketoacidosis have been reported during compassionate use of Signifor.

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