Wirkstoffe & Arzneimittelsicherheit

Nebenwirkungen · Tecvayli

TECVAYLI 10 mg/mL solution for injection TECVAYLI 90 mg/mL solution for injection · Abschnitt 4.8 · PDF-Seite 18–19

HOS-149971 · Präparat HOS-100189

18  Note: Adverse events are graded according to the NCI-CTCAE Version 5.0, with the exception of ICANS and CRS, which were graded by ASTCT consensus grading system (Lee et al 2019). 1 Upper respiratory tract infection includes Acute sinusitis, Adenoviral upper respiratory infection, Bacterial rhinitis, Bronchiolitis, Bronchitis, Bronchitis bacterial, Bronchitis chronic, Bronchitis haemophilus, Bronchitis viral, Chronic sinusitis, Herpes simplex bronchitis, Nasopharyngitis, Pharyngitis, Pharyngitis streptococcal, Respiratory syncytial virus infection, Respiratory tract infection, Respiratory tract infection bacterial, Respiratory tract infection fungal, Respiratory tract infection viral, Rhinitis, Rhinovirus infection, Sinobronchitis, Sinusitis, Sinusitis bacterial, Tracheitis, Tracheobronchitis, Upper respiratory fungal infection, Upper respiratory tract infection, Upper respiratory tract infection bacterial, Viral rhinitis, Viral sinusitis and Viral upper respiratory tract infection. 2 Pneumonia includes Atypical pneumonia, Candida pneumonia, Coronavirus pneumonia, Enterobacter pneumonia, Lower respiratory tract infection, Lower respiratory tract infection bacterial, Lower respiratory tract infection viral, Metapneumovirus pneumonia, Pneumocystis jirovecii pneumonia, Pneumonia, Pneumonia adenoviral, Pneumonia bacterial, Pneumonia chlamydial, Pneumonia cryptococcal, Pneumonia cytomegaloviral, Pneumonia escherichia, Pneumonia fungal, Pneumonia haemophilus, Pneumonia influenzal, Pneumonia klebsiella, Pneumonia legionella, Pneumonia moraxella, Pneumonia mycoplasmal, Pneumonia parainfluenzae viral, Pneumonia pneumococcal, Pneumonia pseudomonal, Pneumonia respiratory syncytial viral, Pneumonia staphylococcal, Pneumonia streptococcal, Pneumonia viral and Stenotrophomonas maltophilia pneumonia. 3 COVID-19 includes COVID-19 and COVID-19 pneumonia. 4 Urinary tract infection includes Cystitis, Cystitis escherichia, Cystitis haemorrhagic, Cystitis klebsiella, Escherichia urinary tract infection, Genitourinary tract infection, Klebsiella urinary tract infection, Pyelonephritis, Pyelonephritis acute, Pyuria, Urinary tract candidiasis, Urinary tract infection, Urinary tract infection bacterial, Urinary tract infection enterococcal, Urinary tract infection fungal and Urinary tract infection staphylococcal. 5 Sepsis includes Abdominal sepsis, Acinetobacter bacteraemia, Bacillus bacteraemia, Bacteraemia, Bacterial sepsis, Campylobacter bacteraemia, Campylobacter sepsis, Citrobacter bacteraemia, Corynebacterium bacteraemia, Device related bacteraemia, Enterococcal bacteraemia, Enterococcal sepsis, Escherichia bacteraemia, Escherichia sepsis, Haemophilus sepsis, Klebsiella sepsis, Meningococcal sepsis, Neutropenic sepsis, Pseudomonal bacteraemia, Pseudomonal sepsis, Pulmonary sepsis, Sepsis, Septic shock, Staphylococcal bacteraemia, Staphylococcal sepsis, Streptococcal sepsis and Urosepsis. 6 Anaemia includes Anaemia, Iron deficiency anaemia, Leukoerythroblastic anaemia and Microcytic anaemia 7 Hypogammaglobulinaemia includes patients with adverse events of hypogammaglobulinaemia, hyperglobulinaemia, immunoglobulins decreased; and/or patients with laboratory IgG levels below 400 mg/dL following treatment with TECVAYLI. 8 Neuropathy peripheral includes Dysaesthesia, Hypoaesthesia, Hypoaesthesia oral, Neuralgia, Neuropathy peripheral, Paraesthesia, Paraesthesia oral, Peripheral motor neuropathy, Peripheral sensory neuropathy and Sciatica. 9 Encephalopathy includes Amnesia, Brain fog, Cognitive disorder, Confusional state, Depressed level of consciousness, Lethargy, Memory impairment and Somnolence. 10 Haemorrhage includes Anal haemorrhage, Conjunctival haemorrhage, Epistaxis, Eye haemorrhage, Eyelid bleeding, Eyelid haematoma, Gastrointestinal haemorrhage, Gingival bleeding, Haematochezia, Haematoma, Haematuria, Haemoperitoneum, Haemoptysis, Haemorrhoidal haemorrhage, Haemorrhoids, Hepatic haemorrhage, Lower gastrointestinal haemorrhage, Melaena, Mouth haemorrhage, Post procedural haemorrhage, Postmenopausal haemorrhage, Pulmonary alveolar haemorrhage, Rectal haemorrhage, Subdural haematoma, Upper gastrointestinal haemorrhage and Vitreous haemorrhage. 11 Hypertension includes Blood pressure increased, Essential hypertension, Hypertension, Hypertensive crisis, Mean arterial pressure increased and Systolic hypertension. 12 Cough includes Allergic cough, Cough, Productive cough and Upper-airway cough syndrome. 13 Dyspnoea includes Acute respiratory failure, Dyspnoea, Dyspnoea exertional and Respiratory failure. 14 Diarrhoea includes Bacterial diarrhoea, Diarrhoea and Viral diarrhoea. 15 Abdominal pain includes Abdominal discomfort, Abdominal pain, Abdominal pain lower, Abdominal pain upper, Epigastric discomfort and Gastrointestinal pain. 16 Musculoskeletal pain includes Arthralgia, Back pain, Bone pain, Musculoskeletal chest pain, Musculoskeletal pain, Myalgia, Neck pain, Pain in extremity and Sacral pain. 17 Injection site reaction includes Administration site pruritus, Administration site reaction, Application site erythema, Injection site bruising, Injection site cellulitis, Injection site discolouration, Injection site discomfort, Injection site eczema, Injection site erythema, Injection site haematoma, Injection site hyperaesthesia, Injection site induration, Injection site inflammation, Injection site irritation, Injection site oedema, Injection site pain, Injection site paraesthesia, Injection site pruritus, Injection site rash, Injection site reaction, Injection site swelling, Injection site vesicles and Injection site warmth. 18 Fatigue includes Asthenia, Fatigue and Malaise. 19 Pain includes Axillary pain, Breast pain, Cancer pain, Chest pain, Ear pain, Eye pain, Facial pain, Flank pain, Gingival pain, Groin pain, Laryngeal pain, Non-cardiac chest pain, Oesophageal pain, Oral pain, Oropharyngeal pain, Pain, Pain in jaw, Pain of skin, Pelvic pain, Perineal pain, Periorbital pain, Sinus pain, Spinal pain, Testicular pain, Toothache and Tumour pain. 20 Oedema includes Eyelid oedema, Face oedema, Localised oedema, oedema, oedema peripheral, Periorbital oedema, Peripheral swelling, Skin oedema, Swelling, Swelling face and Testicular swelling. 21 Transaminase elevation includes Alanine aminotransferase increased, Aspartate aminotransferase, Aspartate aminotransferase increased, Hypertransaminasaemia and Transaminase increased. * Based on post-marketing experience.

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