Nebenwirkungen · Sarclisa
Sarclisa 1 400 mg solution for injection · Abschnitt 4.8 · PDF-Seite 52
HOS-143647 · Präparat HOS-099018
In clinical studies of isatuximab intravenous and subcutaneous formulations (N=2 656), the most commonly reported infections were upper respiratory tract infection (23.0%), pneumonia (22.0%), and bronchitis (11.0%). Grade >3 infections were reported in 29.9% of patients including 16.6% Grade ≥3 pneumonia). Serious infections were reported in 29.0% of patients. The most frequent serious infection was pneumonia (16.5%). Discontinuations from treatment due to infection were reported in 4.0% of patients. Fatal infections were reported in 3.4% of patients. Neutropenic complications have been observed in 9.0% of patients, including 2.5% of febrile neutropenia and 7.2% of neutropenic infections.
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