Wirkstoffe & Arzneimittelsicherheit

Nebenwirkungen · Hycamtin

HYCAMTIN 1 mg powder for concentrate for solution for infusion HYCAMTIN 4 mg powder for concentrate for solution for infusion · Abschnitt 4.8 · PDF-Seite 7

HOS-086068 · Präparat HOS-083256

Neutropenia Severe (neutrophil count <0.5 x 109/l) during course 1 in 55% of patients, with duration  seven days in 20%, and overall in 77% of patients (39% of courses). In association with severe neutropenia, fever or infection occurred in 16% of patients during course 1 and overall in 23% of patients (6% of courses). Median time to onset of severe neutropenia was nine days and the median duration was seven days. Severe neutropenia lasted beyond seven days in 11% of courses overall. Among all patients treated in clinical studies (including both those with severe neutropenia and those who did not develop severe neutropenia), 11% (4% of courses) developed fever and 26% (9% of courses) developed infection. In addition, 5% of all patients treated (1% of courses) developed sepsis (see section 4.4).

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