Wirkstoffe & Arzneimittelsicherheit

Nebenwirkungen · Tevimbra

Tevimbra 100 mg concentrate for solution for infusion · Abschnitt 4.8 · PDF-Seite 11–12

HOS-150209 · Präparat HOS-100272

11 reactions (≥ 20%) were neutropenia (71.6%), anaemia (67.2%), thrombocytopenia (48.7%), nausea (43.3%), fatigue (40.8%), decreased appetite (40.1%), alanine aminotransferase increased (30.6%), aspartate aminotransferase increased (30.3%), rash (21.4%) and diarrhoea (20.3%). The most common Grade 3/4 adverse reactions (≥ 2%) were neutropenia (45.2%), anaemia (14.5%), thrombocytopenia (14.1%), hyponatraemia (4.6%), hypokalaemia (4.5%), fatigue (4.2%), pneumonia (4.0%), lymphopenia (3.1%), rash (2.9%), decreased appetite (2.6%), aspartate aminotransferase increased (2.2%), alanine aminotransferase increased (2.1%). 1.3% of patients experienced adverse reactions leading to death. The adverse reactions leading to death were pneumonia (0.50%), pneumonitis (0.30%), dyspnoea (0.20%), myocarditis (0.20%), hepatitis (0.05%), thrombocytopenia (0.05%), colitis (0.05%), hypokalaemia (0.05%), and myositis (0.05%). Among the 1950 patients, 56.5% were exposed to tislelizumab for 6 months or longer, and 31.9% were exposed for 12 months or longer.

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