Wirkstoffe & Arzneimittelsicherheit

Nebenwirkungen · Zykadia

Zykadia 150 mg hard capsules · Abschnitt 4.8 · PDF-Seite 11–12

HOS-131719 · Präparat HOS-097124

11  General disorders and administration site conditions Fatiguem 48.4 Very common Investigations Liver laboratory test abnormalitiesn 60.5 Very common Weight decreased 27.6 Very common Blood creatinine increased 22.1 Very common Electrocardiogram QT prolonged 9.7 Common Lipase increased 4.8 Common Amylase increased 7.0 Common Includes cases reported within the clustered terms: a Vision disorder (vision impairment, vision blurred, photopsia, vitreous floaters, visual acuity reduced, accommodation disorder, presbyopia) b Pericarditis (pericardial effusion, pericarditis) c Bradycardia (bradycardia, sinus bradycardia) d Pneumonitis (interstitial lung disease, pneumonitis) e The frequency of these selected gastrointestinal ADRs (diarrhoea, nausea and vomiting) is based on patients treated with the recommended dose of ceritinib 450 mg with food (N=108) in the study A2112 (ASCEND-8) (see subsection ‘Gastrointestinal adverse reactions’ below) f Abdominal pain (abdominal pain, abdominal pain upper, abdominal discomfort, epigastric discomfort) g Oesophageal disorder (dyspepsia, gastro-oesophageal reflux disease, dysphagia) h Abnormal liver function test (hepatic function abnormal, hyperbilirubinaemia) i Hepatotoxicity (drug-induced liver injury, hepatitis cholestatic, hepatocellular injury, hepatotoxicity) j Rash (rash, dermatitis acneiform, rash maculopapular) k Renal failure (acute renal injury, renal failure) l Renal impairment (azotaemia, renal impairment) m Fatigue (fatigue, asthenia) n Liver laboratory test abnormalities (alanine aminotransferase increased, aspartate aminotransferase increased, gamma-glutamyltransferase increased, blood bilirubin increased, transaminases increased, hepatic enzyme increased, liver function test abnormal, liver function test increased, blood alkaline phosphatase increased)

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