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 19

HOS-149211 · Präparat HOS-100012

General disorders and administration Pyrexia Very common Uncommon site conditions Aspartate aminotransferase increased Very common Common Alanine aminotransferase increased Very common Common Blood alkaline phosphatase increased Very common Uncommon Gamma-glutamyltransferase increased Very common Common Investigations Blood lactate dehydrogenase Very common Very rare** increased Blood bilirubin increased18 Common Very rare** Hepatic enzyme increased Uncommon Very rare** * Grade 5 reactions reported. See Description of selected adverse reactions. ** No Grade 3-4 events were reported. 1 Includes COVID-19, COVID-19 pneumonia, and SARS-CoV-2 test positive. 2 Includes upper respiratory tract infection, lower respiratory tract infection, respiratory tract infection, and respiratory tract infection bacterial. 3 Includes pneumonia, pneumonia bacterial, and pneumonia pneumococcal. 4 New onset or reactivation. Includes cytomegalovirus infection, cytomegalovirus test positive, cytomegalovirus infection reactivation and cytomegalovirus viraemia. 5 New onset or reactivation. Includes herpes zoster and herpes virus infection. 6 Includes urinary tract infection and urosepsis. 7 Includes sepsis, streptococcal sepsis, septic shock, and enterococcal sepsis. 8 Includes oral candidiasis and candida infection. 9 Includes tumour flare and tumour pain. 10 Based on ASTCT consensus grading (Lee 2019). 11 Includes neuropathy peripheral, peripheral sensory neuropathy, dysaesthesia, paraesthesia, hypoaesthesia, peripheral motor neuropathy, and polyneuropathy. 12 Includes confusional state, delirium, and ICANS. 13 Includes abdominal pain, abdominal discomfort, abdominal pain upper, abdominal pain lower, and gastrointestinal pain. 14 Includes colitis, colitis ischaemic, and enterocolitis. 15 Includes pancreatitis and pancreatitis acute. 16 Includes rash, rash pruritic, rash maculo-papular, erythema, pruritus, rash erythematous, urticaria, and erythema multiforme. 17 Includes arthralgia, musculoskeletal pain, back pain, bone pain, myalgia, neck pain, pain in extremity, musculoskeletal chest pain, and non-cardiac chest pain. 18 Includes blood bilirubin increased and hyperbilirubinaemia.

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