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Pfizer’s XALKORI® Receives Conditional Marketing Authorization From The European Commission For The Treatment Of Adults With Previously Treated ALK-Positive Advanced Non-Small Cell Lung Cancer In The EU

Important XALKORI(crizotinib)Safety Information 4

Hepatotoxicity: Drug-induced hepatotoxicity with fatal outcome has occurred. Transaminase elevations generally occurred within the first 2 months of treatment. XALKORI should not be used in patients with severe hepatic impairment. Liver function tests including alanine aminotransferase (ALT), aspartate aminotransferase (AST), and total bilirubin should be monitored twice a month during the first 2 months of treatment, then once a month and as clinically indicated, with more frequent repeat testing for Grades 2, 3, or 4 elevation. Temporarily suspend, dose reduce, or permanently discontinue XALKORI as indicated.

Pneumonitis: XALKORI has been associated with severe, life-threatening, or fatal treatment-related pneumonitis in clinical trials with a frequency of 4 in 386 (1%) patients. All of these cases occurred within 2 months after the initiation of treatment. Patients with pulmonary symptoms indicative of pneumonitis should be monitored. XALKORI treatment should be withheld if pneumonitis is suspected. Other causes of pneumonitis should be excluded and XALKORI should be permanently discontinued in patients diagnosed with treatment-related pneumonitis.

QT Interval Prolongation: QTc prolongation has been observed, which may lead to an increased risk for ventricular tachyarrhythmias (e.g. Torsades de Pointes) or sudden death. The risk of QTc prolongation may be increased in patients concomitantly taking antiarrhythmics and in patients with relevant pre-existing cardiac disease, bradycardia, or electrolyte disturbances (e.g., secondary to diarrhea or vomiting). XALKORI should be administered with caution to patients who have a history of or predisposition for QTc prolongation, or who are taking medicinal products that are known to prolong the QT interval. When using XALKORI in these patients, periodic monitoring with electrocardiograms and electrolytes should be considered. Permanently discontinue XALKORI for grade 4 QTc prolongation. XALKORI should be withheld for grade 3 QTc prolongation until recovery to ≤ grade 1. Permanently discontinue XALKORI if grade 3 QTc prolongation recurs.

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