Wirkstoffe & Arzneimittelsicherheit

Nebenwirkungen · Casgevy

Casgevy 4 - 13 × 106 cells/mL dispersion for infusion · Abschnitt 4.8 · PDF-Seite 11–12

HOS-149339 · Präparat HOS-100036

Table 3: Adverse reactions attributed to myeloablative conditioning with busulfan in patients with TDT and SCD (N=97) * System organ class (SOC) Very common Common Pneumonia, sepsis, klebsiella Infections and infestations sepsis, oral candidiasis, folliculitis Thrombocytopenia, febrile neutropenia, Blood and lymphatic system Pancytopenia, reticulocytopenia, neutropenia, anaemia, lymphopenia †, disorders splenomegaly leukopenia Decreased appetite, hypokalaemia, Metabolism and nutrition Hypoalbuminaemia, hyperphosphataemia, hypomagnesaemia, disorders hypocalcaemia fluid retention, hypophosphataemia Cerebellar haemorrhage, hydrocephalus, peripheral sensory Nervous system disorders Headache neuropathy, peripheral neuropathy, neuralgia, dysgeusia Eye disorders Vision blurred, dry eye Cardiac disorders Tachycardia Vascular disorders Hypotension, hot flush Respiratory failure, idiopathic Respiratory, thoracic and Epistaxis, oropharyngeal pain pneumonia syndrome, hypoxia, mediastinal disorders dyspnoea, cough Colitis, dyspepsia, gingival bleeding, gastrooesophageal reflux Mucositis ‡, nausea, vomiting, abdominal disease, haematemesis, Gastrointestinal disorders pain §, diarrhoea, constipation, gastritis oesophagitis, dysphagia, gastrointestinal inflammation, haematochezia, mouth ulceration Aspartate aminotransferase Veno-occlusive liver disease, increased, hepatomegaly, Hepatobiliary disorders hyperbilirubinaemia, alanine gamma-glutamyltransferase aminotransferase increased increased 11  System organ class (SOC) Very common Common Skin and subcutaneous Pigmentation disorder #, skin exfoliation, Pruritus, erythema tissue disorders alopecia, petechiae, dry skin, rash ** Musculoskeletal and Musculoskeletal pain †† Arthralgia connective tissue disorders Renal and urinary disorders Dysuria, haematuria Amenorrhoea, intermenstrual Reproductive system and bleeding, vulvovaginal pain, breast disorders dysmenorrhoea, menstruation irregular, premature menopause General disorders and administration site Pyrexia, fatigue Pain conditions International normalised ratio Investigations Weight decreased increased, C-reactive protein increased, weight increased Delayed engraftment, Injury, poisoning procedural subcutaneous haematoma, skin complications abrasion, skin laceration * Frequency is based on the highest incidence from study 111 in patients with TDT or from study 121 in patients with SCD. † Lymphopenia included CD4 lymphocytes decreased and lymphocyte count decreased. ‡ Mucositis included anal inflammation, mucosal inflammation, pharyngeal inflammation, and stomatitis. § Abdominal pain included abdominal discomfort, abdominal pain lower, abdominal pain upper, abdominal tenderness, and

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