Wirkstoffe & Arzneimittelsicherheit

Nebenwirkungen · Yescarta

Yescarta 0.4 – 2 × 108 cells dispersion for infusion · Abschnitt 4.8 · PDF-Seite 13

HOS-139700 · Präparat HOS-098384

a. Coagulopathy includes coagulopathy, blood fibrinogen decreased, blood fibrinogen increased, disseminated intravascular coagulation, hypofibrinogenaemia, international normalized ratio increased, prothrombin level decreased, prothrombin time prolonged b. Immunoglobulins decreased includes blood immunoglobulin G decreased, hypogammaglobulinaemia c. Decreased appetite includes decreased appetite, hypophagia d. Dehydration includes dehydration, hypovolaemia e. Delirium includes delirium, agitation, delusion, disorientation, hallucination, restlessness f. Affective disorder includes impulsive behavior, mood altered, depression, panic attack g. Encephalopathy includes encephalopathy, agraphia, altered state of consciousness, amnesia, aphasia, aphonia, apraxia, cognitive disorder, confusional state, depressed level of consciousness, disturbance in attention, dysarthria, dysgraphia, dyskinesia, dyspraxia, hypersomnia, immune effector cell-associated neurotoxicity syndrome (ICANS), lethargy, leukoencephalopathy, loss of consciousness, memory impairment, mental impairment, mental status changes, metabolic encephalopathy, neurotoxicity, slow speech, somnolence, speech disorder, stupor, toxic encephalopathy h. Tremor includes tremor, head titubation i. Headache includes headache, head discomfort, tension headache j. Dizziness includes dizziness, dizziness postural, presyncope, syncope, vertigo k. Ataxia includes ataxia, balance disorder, gait disturbance l. Facial paralysis includes facial paralysis, facial paresis m. Neuropathy peripheral includes neuropathy peripheral, allodynia, cervical radiculopathy, hyperaesthesia, hypoaesthesia, lumbar radiculopathy, paraesthesia, peripheral sensory neuropathy, peroneal nerve palsy n. Visual impairment includes visual impairment, hemianopia, vision blurred, visual acuity reduced o. Tachycardia includes tachycardia, postural orthostatic tachycardia syndrome, sinus tachycardia p. Arrhythmia includes arrhythmia, atrial fibrillation, atrial flutter, atrioventricular block, bradycardia, bundle branch block right, electrocardiogram QT prolonged, extrasystoles, heart rate increased, heart rate irregular, sinus bradycardia, supraventricular extrasystoles, supraventricular tachycardia, ventricular arrhythmia, ventricular extrasystoles, ventricular tachycardia q. Cardiac failure includes cardiac failure, acute left ventricular failure, ejection fraction decreased, stress cardiomyopathy r. Hypotension includes hypotension, capillary leak syndrome, diastolic hypotension, hypoperfusion, orthostatic hypotension s. Thrombosis includes thrombosis, axillary vein thrombosis, brachiocephalic vein thrombosis, deep vein thrombosis, device occlusion, embolism, jugular vein thrombosis, peripheral embolism, peripheral ischaemia, pulmonary embolism, splenic vein thrombosis, thrombosis in device t. Haemorrhage includes serious and potentially fatal haemorrhagic events such as gastrointestinal haemorrhage, pulmonary haemorrhage and intracranial haemorrhage u. Cough includes cough, productive cough, upper-airway cough syndrome v. Respiratory failure includes respiratory failure, acute respiratory failure w. Hypoxia includes hypoxia, oxygen saturation decreased x. Dyspnoea includes dyspnoea, dyspnoea exertional y. Nasal inflammation includes rhinitis allergic, rhinorrhoea z. Diarrhoea includes diarrhoea, colitis, enteritis aa. Abdominal pain includes abdominal pain, abdominal discomfort, abdominal pain lower, abdominal pain upper, abdominal tenderness, dyspepsia, epigastric discomfort bb. Dry mouth includes dry mouth, lip dry cc. Transaminases increased includes transaminases increased, alanine aminotransferase increased, aspartate aminotransferase increased, hepatic enzyme increased, hypertransaminasaemia dd. Hyperbilirubinaemia increased includes hyperbilirubinemia, blood bilirubin increased ee. Rash includes rash, application site rash, dermatitis, dermatitis allergic, dermatitis bullous, erythema, pruritus, rash erythematous, rash macular, rash maculo-papular, rash pruritic, rash pustular, urticaria ff. Motor dysfunction includes motor dysfunction, muscle contractions involuntary, muscle rigidity, muscle spasms, muscle spasticity, muscle strain, muscle tightness, muscle twitching, muscular weakness gg. Musculoskeletal pain includes musculoskeletal pain, arthralgia, arthritis, back pain, bone pain, flank pain, groin pain, musculoskeletal chest pain, myalgia, neck pain, osteoarthritis, pain in extremity hh. Renal impairment includes acute kidney injury, blood creatinine increased, renal failure ii. Fever includes hyperthermia, pyrexia jj. Oedema includes oedema, face oedema, generalized oedema, localized oedema, oedema genital, oedema peripheral, peripheral swelling, swelling kk. Fatigue includes fatigue, asthenia, decreased activity, malaise

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