Wirkstoffe & Arzneimittelsicherheit

Nebenwirkungen · Zypadhera

ZYPADHERA 210 mg powder and solvent for prolonged release suspension for injection ZYPADHERA 300 mg powder and solvent for prolonged release suspension for injection ZYPADHERA 405 mg powder and solvent for prolonged release suspension for injection · Abschnitt 4.8 · PDF-Seite 11–12

HOS-119670 · Präparat HOS-094989

11  in males and females females Gynaecomastia/ breast enlargement in males General disorders and administration site conditions Asthenia Injection site Fatigue abscess Oedema Pyrexia10 Injection site pain Investigations Elevated plasma Increased alkaline Increased total prolactin levels8 phosphatase10 bilirubin High creatine phosphokinase11 High Gamma Glutamyltransfera se 10 High uric acid 10 1 Clinically significant weight gain was observed across all baseline Body Mass Index (BMI) categories. Following short term treatment (median duration 47 days), weight gain ≥ 7% of baseline body weight was very common (22.2 %), ≥ 15 % was common (4.2 %) and ≥ 25 % was uncommon (0.8 %). Patients gaining ≥ 7 %, ≥ 15 % and ≥ 25% of their baseline body weight with long-term exposure (at least 48 weeks) were very common (64.4 %, 31.7 % and 12.3 % respectively). 2 Mean increases in fasting lipid values (total cholesterol, LDL cholesterol, and triglycerides) were greater in patients without evidence of lipid dysregulation at baseline. 3 Observed for fasting normal levels at baseline (< 5.17 mmol/l) which increased to high (≥ 6.2 mmol/l). Changes in total fasting cholesterol levels from borderline at baseline (≥ 5.17 - < 6.2 mmol/l) to high (≥ 6.2 mmol/l) were very common.

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