Nebenwirkungen · Koselugo
Koselugo 10 mg hard capsules Koselugo 25 mg hard capsules · Abschnitt 4.8 · PDF-Seite 9
HOS-145447 · Präparat HOS-099352
In the SPRINKLE study, at the time of first data cut-off (DCO1), the median total duration of selumetinib treatment was 11 months (range: < 3 – < 26 months). Thirty-six paediatric patients were treated with selumetinib granules equivalent to 25 mg/m2 twice daily. The most common adverse reactions of any grade (incidence ≥ 40%) were pyrexia and dry skin (47% patients each); and paronychia (44%). Adverse events leading to dose interruptions were reported in 30.6% of patients, while no patients had AEs leading to dose reductions. A total 22.2% patients had ADRs leading to dose modification (either dose interruptions or reductions). The ADRs leading to dose modification (incidence ≥ 5%) were vomiting and pyrexia (11.1% patients each), and diarrhea (5.6%). No patient had ADRs that led to treatment discontinuation.
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