Nebenwirkungen · Koselugo
Koselugo 10 mg hard capsules Koselugo 25 mg hard capsules · Abschnitt 4.8 · PDF-Seite 9
HOS-145446 · Präparat HOS-099352
In the NF1-PN Paediatric pool, the most common adverse reactions of any grade (incidence ≥ 40%) were vomiting (62%), acneiform rashes (60%), diarrhoea (56%), blood creatine phosphokinase increased (54%), nausea (52%), paronychia (50%), and dry skin and pyrexia (44% each). Adverse events leading to dose interruptions and reductions were reported in 61.9% and 27.8% of patients, respectively. A total of 47.6% patients had ADRs leading to dose modification of selumetinib (either dose interruptions or reductions). The ADRs leading to dose modification (incidence ≥ 5%) of selumetinib were vomiting (19.8%), paronychia (15.9%), nausea (11.1%), diarrhea (8.7%), pyrexia (6.3%), and rashes (acneiform and non-acneiform; 5.6% each). Any ADRs leading to treatment discontinuation were reported in 4.8% patients.
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Version 2026-10-15T11:39:00Z · SHA-256 a60a44b68868ce8319831dcd6488fab0fc72cf8efb09ef2ef5822453e45d0860 · Passage 57253bde4c9d9de6d9d56e333cefd512ae512163b55547c344be6965608be08f · Zeichen 1439–2246 im Abschnitt