Wirkstoffe & Arzneimittelsicherheit

Nebenwirkungen · Kymriah

Kymriah 1.2 × 106 – 6 × 108 cells dispersion for infusion · Abschnitt 4.8 · PDF-Seite 12–13

HOS-134897 · Präparat HOS-097630

12 Metabolism and nutrition disorders Very common: Decreased appetite, hypokalaemia, hypophosphataemia Common: Hypomagnesaemia, hypoalbuminaemia4), hyperglycaemia, hyponatraemia, hyperuricaemia5), hypercalcaemia, tumour lysis syndrome, hyperkalaemia, hyperphosphataemia6), hypernatraemia, hyperferritinaemia7), hypocalcaemia Uncommon: Hypermagnesaemia Psychiatric disorders Common: Anxiety, delirium8), sleep disorder9) Nervous system disorders Very common: Headache10), encephalopathy11) Common: Dizziness12), peripheral neuropathy13), tremor14), motor dysfunction15), seizure16), immune effector cell-associated neurotoxicity syndrome**, speech disorders17), neuralgia18) Uncommon: Ischaemic cerebral infarction, ataxia19) Not known: Neurotoxicity Eye disorders Common: Visual impairment20) Cardiac disorders Very common: Tachycardia21) Common: Cardiac failure22), cardiac arrest, atrial fibrillation Uncommon: Ventricular extrasystoles Vascular disorders Very common: Haemorrhage23), hypotension24), hypertension Common: Thrombosis25), capillary leak syndrome Uncommon: Flushing Respiratory, thoracic and mediastinal disorders Very common: Cough26), dyspnoea27), hypoxia Common: Oropharyngeal pain28), pulmonary oedema29), nasal congestion, pleural effusion, tachypnoea Uncommon: Acute respiratory distress syndrome, lung infiltration Gastrointestinal disorders Very common: Diarrhoea, nausea, vomiting, constipation, abdominal pain30) Common: Stomatitis, abdominal distension, dry mouth, ascites Hepatobiliary disorders Common: Hyperbilirubinaemia Skin and subcutaneous tissue disorders Very common: Rash31) Common: Pruritus, erythema, hyperhidrosis, night sweats Musculoskeletal and connective tissue disorders Very common: Arthralgia, musculoskeletal pain32) Common: Myalgia Renal and urinary disorders Very common: Acute kidney injury33) General disorders and administration site conditions Very common: Pyrexia, fatigue34), oedema35), pain36) Common: Influenza-like illness, asthenia, multiple organ dysfunction syndrome, chills Investigations Very common: Lymphocyte count decreased*, white blood cell count decreased*, haemoglobin decreased*, neutrophil count decreased*, platelet count decreased*, hepatic enzyme increased37) Common: Blood bilirubin increased, weight decreased, blood fibrinogen decreased, international normalised ratio increased, fibrin D dimer increased, activated partial thromboplastin time prolonged, prothrombin time prolonged 1) Infections and infestations presented reflect high-level group terms.

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