Nebenwirkungen · Koselugo
Koselugo 10 mg hard capsules Koselugo 25 mg hard capsules · Abschnitt 4.8 · PDF-Seite 13
HOS-145472 · Präparat HOS-099352
In the NF1-PN adult patients (N = 137), ADRs of blood CPK increase occurred in 51 (37%) patients. The median time to first onset of the maximum CTCAE grade blood CPK increase was 103 days (approximately 3 months), and the median duration of maximum grade event was 122 days (approximately 4 months). Forty-two patients (30.7%) had maximum CTCAE grade of 1 or 2. A maximum CTCAE grade 3 events occurred in 5 (3.6%) patients, and CTCAE grade 4 events occurred in 4 (2.9%) patients. Six patients had an event of blood CPK increase that led to dose interruptions and dose reduction was required in 3 patients. At the time of analysis, 21 of the 51 patients had recovered.
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