Wirkstoffe & Arzneimittelsicherheit

Nebenwirkungen · Reblozyl

Reblozyl 25 mg powder for solution for injection Reblozyl 75 mg powder for solution for injection · Abschnitt 4.8 · PDF-Seite 10–11

HOS-226910 · Präparat HOS-217694

10 System organ class Preferred term Frequency Frequency (all grades) for (all grades) for MDS β-thalassaemia Gastrointestinal disorders abdominal pain Common Very commonb abdominal Common discomfort diarrhoea Very common Very commona nausea Very common Very common Skin and subcutaneous tissue hyperhidrosis Common disorders Musculoskeletal and connective back pain Very common Very common tissue disorders arthralgiaVI Common Very common bone painVI Common Very common myalgia Common muscular weakness Common Renal and urinary disorders proteinuria Commonb albuminuria Commonb kidney injuryX Common General disorders and non-cardiac chest Common administration site conditions pain influenza-like Common illness fatigue Very common Very commona asthenia Very common Very common injection site Common Common reactionsIII, VI oedema peripheral Very common Investigations alanine Common CommonV aminotransferase increased aspartate Common Very commonV aminotransferase increased blood bilirubin Common Very commonV increased gamma- Common glutamyltransferase increased Injury, poisoning and procedural traumatic fractureVI Commonb complications The four pivotal studies are ACE-536-MDS-001(ESA-refractory or -intolerant MDS), ACE-536-MDS-002 (MDS), ACE-536-B-THAL-001 (transfusion-dependent β-thalassaemia) and ACE-536-B-THAL-002 (non-transfusion-dependent β-thalassaemia). I Hypersensitivity includes eyelid oedema, drug hypersensitivity, swelling face, periorbital oedema, face oedema,

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