Gilotrif(阿法替尼,Bibw 2992)说明书.pdfVIP

HIGHLIGHTS OF PRESCRIBING INFORMATION  Interstitial lung disease (ILD): Occurs in 1.5% of patients. Withhold These highlights do not include all the information needed to use GILOTRIF for acute onset or worsening of pulmonary symptoms. GILOTRIF safely and effectively. See full prescribing information for Discontinue GILOTRIF if ILD is diagnosed. (2.3, 5.3) GILOTRIF.  Hepatic toxicity: Fatal hepatic impairment occurs in 0.18% of patients. Monitor with periodic liver testing. Withhold or discontinue GILOTRIF for GILOTRIF™ (afatinib) tablets, for oral use severe or worsening liver tests. (2.3, 5.4) Initial U.S. Approval: 2013  Keratitis: Occurs in 0.8% of patients. Withhold GILOTRIF for keratitis evaluation. Withhold or discontinue GILOTRIF for confirmed ulcerative INDICATIONS AND USAGE keratitis. (2.3, 5.5) GILOTRIF is a kinase inhibitor indicated for the first-line treatment of  Embryofetal toxicity: Can cause fetal harm. Advise females of the potential patients with metastatic non-small cell lung cancer (NSCLC) whose tumors hazard to the fetus and to use highly effective contraception. (5.6) have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations as detected by an FDA-approved test (1) ADVERSE REACTIONS