Wirkstoffe & Arzneimittelsicherheit

Nebenwirkungen · Imfinzi

IMFINZI 50 mg/ml concentrate for solution for infusion. · Abschnitt 4.8 · PDF-Seite 21–22

HOS-141816 · Präparat HOS-098696

21  IMFINZI in combination with IMFINZI in combination with tremelimumab 75 mg and platinum- tremelimumab 300 mg based chemotherapy Hepatobiliary disorders Very common Aspartate aminotransferase Aspartate aminotransferase increased/Alanine aminotransferase increased/Alanine aminotransferase increasedv increasedv Common Hepatitisw Hepatitisw Skin and subcutaneous tissue disorders Very common Alopeciad, Rashx, Pruritus Rashx, Pruritus Common Dermatitisy, Night sweats, Uncommon Dermatitis, Night sweats, Pemphigoid Pemphigoid Musculoskeletal and connective tissue disorders Very common Arthralgia Common Myalgia Myalgia z z Uncommon Myositis , Polymyositis , Immune- Myositisz, Polymyositisz, Immune-mediated n mediated arthritis arthritis, Polymyalgia rheumatica Not known Polymyalgia rheumatican Renal and urinary disorders Common Blood creatinine increased, Dysuria Blood creatinine increased, Dysuria Uncommon Nephritis, Cystitis noninfective Nephritisaa Not known Cystitis noninfectiveh General disorders and administration site conditions Very common Fatigued, Pyrexia Pyrexia, Oedema peripheralbb Common Oedema peripheralbb Injury, poisoning and procedural complications Common Infusion-related reactioncc Infusion-related reactioncc a Includes laryngitis, nasopharyngitis, pharyngitis, rhinitis, sinusitis, tonsillitis, tracheobronchitis and upper respiratory tract infection. b Includes pneumocystis jirovecii pneumonia, pneumonia and pneumonia bacterial. c Includes periodontitis, pulpitis dental, tooth abscess and tooth infection. d Adverse reaction only applies to chemotherapy ADRs in the POSEIDON study. e Includes neutropenia and neutrophil count decreased. f Includes platelet count decreased and thrombocytopenia. g Includes leukopenia and white blood cell count decreased. h Adverse reaction was not observed in the HCC pool, but was reported in patients treated with IMFINZI or IMFINZI+tremelimumab in AstraZeneca-sponsored clinical studies. i Includes blood thyroid stimulating hormone increased, hypothyroidism and immune-mediated hypothyroidism. j Includes blood thyroid stimulating hormone decreased and hyperthyroidism. k Includes autoimmune thyroiditis, immune-mediated thyroiditis, thyroiditis and thyroiditis subacute. l Includes neuropathy peripheral, paraesthesia and peripheral sensory neuropathy. m Includes encephalitis and encephalitis autoimmune. n Adverse reaction was not observed in the POSEIDON study but was reported in patients treated with IMFINZI or IMFINZI+tremelimumab in clinical studies outside of the POSEIDON dataset. o Reported in studies outside of the POSEIDON study and HCC pool. p Includes autoimmune myocarditis. q Includes immune-mediated pneumonitis and pneumonitis. r Includes abdominal pain, abdominal pain lower, abdominal pain upper and flank pain. s Includes mucosal inflammation and stomatitis. t Includes colitis, enteritis and enterocolitis. u Includes autoimmune pancreatitis, pancreatitis and pancreatitis acute. v Includes alanine aminotransferase increased, aspartate aminotransferase increased, hepatic enzyme increased and transaminases increased.

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