Wirkstoffe & Arzneimittelsicherheit

Nebenwirkungen · Kymriah

Kymriah 1.2 × 106 – 6 × 108 cells dispersion for infusion · Abschnitt 4.8 · PDF-Seite 13–14

HOS-134898 · Präparat HOS-097630

13 2) Hypogammaglobulinaemia includes blood immunoglobulin A decreased, blood immunoglobulin G decreased, blood immunoglobulin M decreased, hypogammaglobulinaemia, immunodeficiency, immunodeficiency common variable and immunoglobulins decreased. 3) Graft-versus-host disease (GvHD) includes GvHD, GvHD in gastrointestinal tract, GvHD in skin 4) Hypoalbuminaemia includes blood albumin decreased, hypoalbuminaemia 5) Hyperuricaemia includes blood uric acid increased, hyperuricaemia 6) Hyperphosphataemia includes blood phosphorus increased, hyperphosphataemia 7) Hyperferritinaemia includes hyperferritinaemia, serum ferritin increased 8) Delirium includes agitation, delirium, hallucination, hallucination visual, irritability and restlessness. 9) Sleep disorder includes insomnia, nightmare and sleep disorder. 10) Headache includes headache and migraine. 11) Encephalopathy includes automatism, cognitive disorder, confusional state, depressed level of consciousness, disturbance in attention, encephalopathy, lethargy, memory impairment, mental status changes, metabolic encephalopathy, somnolence and thinking abnormal. Encephalopathy is a dominant feature of immune effector cell-associated neurotoxicity syndrome (ICANS), along with other symptoms. 12) Dizziness includes dizziness, presyncope and syncope. 13) Peripheral neuropathy includes dysaesthesia, hyperaesthesia, hypoaesthesia, neuropathy peripheral, paraesthesia and peripheral sensory neuropathy. 14) Tremor includes dyskinesia and tremor. 15) Motor dysfunction includes muscle spasms, muscle twitching, myoclonus and myopathy. 16) Seizure includes generalised tonic-clonic seizures, seizure and status epilepticus. 17) Speech disorders includes aphasia, dysarthria and speech disorders. 18) Neuralgia includes neuralgia and sciatica. 19) Ataxia includes ataxia and dysmetria. 20) Visual impairment includes vision blurred and visual impairment. 21) Tachycardia includes sinus tachycardia, supraventricular tachycardia, tachycardia 22) Cardiac failure includes cardiac failure, cardiac failure congestive, left ventricular dysfunction and right ventricular dysfunction. 23) Haemorrhage includes anal haemorrhage, blood blister, blood urine present, catheter site haemorrhage, cerebral haemorrhage, conjunctival haemorrhage, contusion, cystitis haemorrhagic, disseminated intravascular coagulation, duodenal ulcer haemorrhage, ecchymosis, epistaxis, eye contusion, gastrointestinal haemorrhage, gingival bleeding, haemarthrosis, haematemesis, haematochezia, haematoma, haematuria, haemoptysis, heavy menstrual bleeding, injection site haematoma, intermenstrual bleeding, large intestinal haemorrhage, lip haemorrhage, melaena, mouth haemorrhage, mucosal haemorrhage, oral blood blister, periorbital haematoma, peritoneal haematoma, petechiae, pharyngeal haemorrhage, post-procedural haemorrhage, pulmonary haemorrhage, purpura, rectal haemorrhage, retinal haemorrhage, stoma site haemorrhage, subcutaneous haematoma, subdural haematoma, subdural haemorrhage, tooth socket haemorrhage, tracheal haemorrhage, traumatic haematoma, tumour haemorrhage, upper gastrointestinal haemorrhage and vaginal haemorrhage. 24) Hypotension includes hypotension and orthostatic hypotension. 25) Thrombosis includes deep vein thrombosis, embolism, pulmonary embolism, thrombosis, vena cava thrombosis and venous thrombosis. 26) Cough includes cough, productive cough and upper-airway cough syndrome. 27) Dyspnoea includes acute respiratory failure, dyspnoea, dyspnoea exertional, respiratory distress and respiratory failure. 28) Oropharyngeal pain includes oral pain and oropharyngeal pain. 29) Pulmonary oedema includes acute pulmonary oedema and pulmonary oedema. 30) Abdominal pain includes abdominal discomfort, abdominal pain, abdominal pain lower, abdominal pain upper and gastrointestinal pain. 31) Rash includes dermatitis, dermatitis acneiform, dermatitis contact, rash, rash maculo-papular, rash papular and rash pruritic.

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