Nebenwirkungen · Halaven
HALAVEN 0.44 mg/ml solution for injection · Abschnitt 4.8 · PDF-Seite 8–9
HOS-124175 · Präparat HOS-095809
8 307/404 (76.0%) and 1314/1559 (84.3%), respectively. The median duration of treatment was 12.0 weeks for sarcoma patients and 15.9 weeks for breast cancer patients. Fatal cases of febrile neutropenia, neutropenic sepsis, sepsis and septic shock have been reported. Out of 1963 breast cancer and soft tissue sarcoma patients who received eribulin at the recommended dose in clinical trials there was one fatal event each of neutropenic sepsis (0.1%) and febrile neutropenia (0.1%). In addition there were 3 fatal events of sepsis (0.2%) and one of septic shock (0.1%). Severe neutropenia may be managed by the use of G-CSF or equivalent at the physician’s discretion in accordance with relevant guidelines. 18% and 13% of eribulin treated patients received G-CSF in the two phase 3 breast cancer studies (Studies 305 and 301, respectively). In the phase 3 sarcoma study (Study 309), 26% of the eribulin treated patients received G-CSF. Neutropenia resulted in discontinuation in < 1% of patients receiving eribulin.
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Version 2024-10-11T15:05:00Z · SHA-256 31249ef6210ad802092fdf0a12213640c232c7a0e17f9862972975afd370495d · Passage a58a1e920b12635d0dedd5e5d158a6fe5d75c4f6478c5aaa5e3c9925dff1f80f · Zeichen 10522–11539 im Abschnitt