Wirkstoffe & Arzneimittelsicherheit

Nebenwirkungen · Columvi

Columvi 2.5 mg concentrate for solution for infusion Columvi 10 mg concentrate for solution for infusion · Abschnitt 4.8 · PDF-Seite 17

HOS-149206 · Präparat HOS-100012

Constipation Very common Very rare** Diarrhoea Very common Very rare** Gastrointestinal Nausea Very common Very rare** disorders Gastrointestinal haemorrhage12 Common Common Vomiting Common Very rare** Colitis Uncommon Uncommon Skin and subcutaneous Rash13 Very common Common tissue disorders General disorders and administration Pyrexia Very common Very rare** site conditions Alanine aminotransferase increased Common Common Aspartate aminotransferase increased Common Common Blood alkaline phosphatase increased Common Common Investigations Gamma-glutamyltransferase increased Common Common Blood bilirubin increased Common Uncommon Hepatic enzyme increased Common Common * Grade 5 reactions reported. See Description of selected adverse reactions. ** No Grade 3-4 events were reported. 1 Includes COVID-19, COVID-19 pneumonia, herpes zoster, influenza, and ophthalmic herpes zoster. 2 Includes vascular device infection, bacterial infection, Campylobacter infection, biliary tract infection bacterial, urinary tract infection bacterial, Clostridium difficile infection, Escherichia infection, and peritonitis. 3 Includes upper respiratory tract infection, sinusitis, nasopharyngitis, chronic sinusitis, and rhinitis. 4 Includes sepsis and septic shock. 5 Includes lower respiratory tract infection and bronchitis. 6 Includes urinary tract infection and Escherichia urinary tract infection. 7 Includes oesophageal candidiasis and oral candidiasis. 8 Includes febrile neutropenia and neutropenic infection. 9 Based on ASTCT consensus grading (Lee 2019). 10 ICANS based on Lee 2019 and includes somnolence, cognitive disorder, confusional state, delirium, and disorientation. 11 Myelitis occurred concurrently with CRS. 12 Includes gastrointestinal haemorrhage, large intestinal haemorrhage, and gastric haemorrhage. 13 Includes rash, rash pruritic, rash maculo-papular, dermatitis, dermatitis acneiform, dermatitis exfoliative, erythema, palmar erythema, pruritis, and rash erythematous.

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