Nebenwirkungen · Koselugo
Koselugo 10 mg hard capsules Koselugo 25 mg hard capsules · Abschnitt 4.8 · PDF-Seite 12
HOS-145461 · Präparat HOS-099352
Left ventricular ejection fraction (LVEF) reduction In the NF1-PN Paediatric Pool (N=126), LVEF reduction (PT: ejection fraction decreased) was reported in 26 (21%) patients; among them, in 25 (19.8%) patients, the reported ADRs were CTCAE grade 2, and in 1 (0.8%) patient, the ADR reported was CTCAE grade 3. In 4 (3.2%) patients, LVEF decrease led to dose reduction and in 2 (1.6%) patients, LVEF decrease led to dose interruption. At the time of analysis, of the 26 patients, 20 patients were recovered. The median time to first onset of maximum CTCAE grade LVEF reduction was 283 days (median duration 110.5 days).
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