Wirkstoffe & Arzneimittelsicherheit

Nebenwirkungen · Blincyto

BLINCYTO 38.5 micrograms powder for concentrate and solution for solution for infusion. · Abschnitt 4.8 · PDF-Seite 18

HOS-130856 · Präparat HOS-096973

Event terms that represent the same medical concept or condition were grouped together and reported as a single adverse reaction in the table above. The terms contributing to the relevant adverse reaction are indicated below: 1 Anaemia includes anaemia and haemoglobin decreased. 2 Neutropenia includes neutropenia and neutrophil count decreased. 3 Thrombocytopenia includes platelet count decreased and thrombocytopenia. 4 Leukopenia includes leukopenia and white blood cell count decreased. 5 Leukocytosis includes leukocytosis and white blood cell count increased. 6 Lymphopenia includes lymphocyte count decreased and lymphopenia. 7 Tachycardia includes sinus tachycardia, supraventricular tachycardia, tachycardia, atrial tachycardia and ventricular tachycardia. 8 Hypotension includes blood pressure decreased and hypotension. 9 Hypertension includes blood pressure increased and hypertension. 10 Hyperbilirubinaemia includes blood bilirubin increased and hyperbilirubinaemia. 11 Rash includes erythema, rash, rash erythematous, rash generalised, rash macular, rash maculo-papular, rash pruritic, catheter site rash, rash pustular, genital rash, rash papular and rash vesicular. 12 Pyrexia includes body temperature increased and pyrexia. 13 Oedema includes bone marrow oedema, periorbital oedema, eyelid oedema, eye oedema, lip oedema, face oedema, localised oedema, generalised oedema, oedema, oedema peripheral, infusion site oedema, oedematous kidney, scrotal oedema, oedema genital, pulmonary oedema, laryngeal oedema, angioedema, circumoral oedema and lymphoedema. 14 Chest pain includes chest discomfort, chest pain, musculoskeletal chest pain and non-cardiac chest pain. 15 Hepatic enzyme increased includes alanine aminotransferase increased, aspartate aminotransferase increased, gamma-glutamyl transferase increased, hepatic enzyme increased, liver function test increased and transaminases increased. 16 Decreased immunoglobulins includes blood immunoglobulin G decreased, blood immunoglobulin A decreased, blood immunoglobulin M decreased, globulins decreased, hypogammaglobulinaemia, hypoglobulinaemia and immunoglobulins decreased. 17 Infusion-related reactions is a composite term that includes the term infusion-related reaction and the following events occurring with the first 48 hours of infusion and event lasted ≤ 2 days: pyrexia, cytokine release syndrome, hypotension, myalgia, acute kidney injury, hypertension, rash, tachypnoea, swelling face, face oedema and rash erythematous. 18 Events may represent ICANS.

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