Nebenwirkungen · Lumykras
LUMYKRAS 120 mg film-coated tablets LUMYKRAS 240 mg film-coated tablets · Abschnitt 4.8 · PDF-Seite 10
HOS-147874 · Präparat HOS-099774
ILD/pneumonitis In clinical studies, among 740 patients who received LUMYKRAS 960 mg once daily as monotherapy, ILD/pneumonitis occurred in 1.9% of patients; ILD/pneumonitis was grade 3 or 4 at onset on 0.8% of patients. A case of fatal ILD occurred in a patient with metastatic NSCLC stage IVB treated with LUMYKRAS in a clinical trial. The patient developed lower respiratory tract infection with a fatal outcome despite steroids and antibiotics treatment. The fatal ILD occurred in a setting of massive disease progression. The median time to first onset for ILD/pneumonitis was 10.6 weeks (range: 2 to 43.3 weeks). LUMYKRAS was discontinued due to ILD/pneumonitis in 0.9% of patients (see sections 4.2 and 4.4).
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