Nebenwirkungen · Alecensa
Alecensa 150 mg hard capsules · Abschnitt 4.8 · PDF-Seite 10
HOS-135889 · Präparat HOS-097784
Interstitial lung disease (ILD) / pneumonitis Across clinical trials, ILD/pneumonitis occurred in 1.7 % of patients treated with Alecensa. 0.4 % of these cases were Grade 3 and treatment discontinuations due to ILD/pneumonitis occurred in 1.1 % of patients, and in 0.4 % of patients, the event led to dose modifications. In the phase III clinical trial BO28984, Grade 3 or 4 ILD/pneumonitis was not observed in patients receiving Alecensa versus 2.0 % of patients receiving crizotinib. There were no fatal cases of ILD in any of the clinical trials. Patients should be monitored for pulmonary symptoms indicative of pneumonitis (see sections 4.2 and 4.4).
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