Wirkstoffe & Arzneimittelsicherheit

Nebenwirkungen · Koselugo

Koselugo 10 mg hard capsules Koselugo 25 mg hard capsules · Abschnitt 4.8 · PDF-Seite 10–11

HOS-145459 · Präparat HOS-099352

10  MedDRA SOC and Paediatric Pool a KOMET Study b MedDRA term (N = 126) (N = 137) Overall Frequency of Overall Frequency of Frequency CTCAE Grade 3 Frequency CTCAE (All CTCAE and above d (All CTCAE Grade 3 and Grades) c Grades) c above e ^ Blood CPK increased Very common Common (6%) Very common Common (7%) (54%) (37%) AST increased Very common Common (2%) Very common Common (1%) (37%) (12%) * Haemoglobin decreased Very common Common (2%) Very common Common (2%) (35%) (11%) Blood albumin decreased * Very common - Common (2%) - (35%) ALT increased Very common Common (2%) Very common Common (1%) (29%) (11%) Ejection fraction decreased ^ Very common Common (1%) Common (7%) Common (1%) (21%) Blood creatinine increased Very common Common (1%) Common (2%) - (19%) Increased blood pressure * Very common - Common (4%) Common (2%) (11%) a NF1-PN Paediatric Pool data (N = 126) is pooled from SPRINT Phase I (N = 24), SPRINT Phase II, Stratum 1 (N = 50), China Phase I study; paediatric cohort (N=16), Japan Phase I Study (N=12), and Phase I Food effect (N=24) studies. Frequency percentage numbers are rounded to the nearest full number. b NF1-PN adult patients data is from KOMET study (N = 137). Frequency percentage numbers are rounded to the nearest full number. c Per National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE), all studies used CTCAE v5.0, except for SPRINT paediatric study which used CTCAE v4.03. d All events were CTCAE grade 3, except for two CTCAE grade 4 event of blood CPK increased and one CTCAE grade 4 event of blood creatinine increased. There were no deaths. e All events were CTCAE grade 3, except for one CTCAE grade 4 event of pyrexia and four CTCAE grade 4 events of blood CPK increased. There were no deaths. f In the SPRINT study, all lab abnormalities were reported as AEs. In other studies included in the NF1-PN paediatric and adult patients, lab abnormalities were only reported as AEs when they met SAE criteria, resulted in discontinuation, or were clinically relevant as judged by the investigator. CPK = creatine phosphokinase; AST = aspartate aminotransferase; ALT = alanine aminotransferase ^ See Description of selected adverse reactions †† Identified ADRs from other clinical trial experience in adult patients (N = 347), with multiple tumour types, receiving treatment with selumetinib (75 mg twice daily). These ADRs have not been reported in paediatric or adult population with NF1 who have inoperable PN. * ADRs based on grouping of individual Preferred Terms (PT): Asthenic events: fatigue, asthenia Blood albumin decreased: hypoalbuminaemia, blood albumin decreased CSR/RPED: detachment of macular retinal pigment epithelium, chorioretinopathy, and retinopathy Dyspnoea: dyspnoea exertional, dyspnoea, dyspnoea at rest Facial oedema: periorbital oedema, face oedema, lip swelling, eyelid oedema, swelling face Haemoglobin decreased: anaemia, haemoglobin decreased Hair changes: alopecia, hair colour change Increased blood pressure: blood pressure increased, hypertension Peripheral oedema: oedema peripheral, oedema, localised oedema, peripheral swelling Rashes (acneiform): dermatitis acneiform, acne, folliculitis Rashes (non-acneiform): rash pruritic, rash maculo-papular, rash papular, rash, rash erythematous, rash macular RVO: retinal vascular disorder, retinal vein occlusion, retinal vein thrombosis Stomatitis: stomatitis, mouth ulceration, aphthous ulcer, gingival swelling

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