Nebenwirkungen · Xalkori
XALKORI 200 mg hard capsules XALKORI 250 mg hard capsules XALKORI 20 mg granules in capsules for opening XALKORI 50 mg granules in capsules for opening XALKORI 150 mg granules in capsules for opening · Abschnitt 4.8 · PDF-Seite 23
HOS-126333 · Präparat HOS-096239
Adult patients with NSCLC Severe, life-threatening, or fatal ILD/pneumonitis can occur in patients treated with crizotinib. Across studies in adult patients with either ALK-positive or ROS1-positive NSCLC (N=1722), 50 (3%) patients treated with crizotinib had any grade all-causality ILD, including 18 (1%) patients with Grade 3 or 4, and 8 (<1%) patients with fatal cases. According to an independent review committee (IRC) assessment of patients with ALK-positive NSCLC (N=1669), 20 (1.2%) patients had ILD/pneumonitis, including 10 (<1%) patients with fatal cases. These cases generally occurred within 3 months after the initiation of treatment.
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