1st-line treatment of adult patients w/ anaplastic lymphoma kinase (ALK)-+ve advanced NSCLC. ALK-+ve, locally advanced or metastatic NSCLC who have progressed on or are intolerant to crizotinib.
Monitor for pulmonary symptoms indicative of pneumonitis; LFTs including ALT, AST & total bilirubin at baseline & then every 2 wk during the 1st 3 mth of treatment, then periodically during treatment, w/ more frequent testing in patients who develop transaminase & bilirubin elevations; heart rate & BP as bradycardia may occur. Severe myalgia & creatine phosphokinase (CPK) elevation. Assess CPK levels every 2 wk for the 1st mth of treatment & as clinically indicated in patients reporting symptoms. Concomitant use w/ drugs known to cause bradycardia including antihypertensives. Avoid prolonged sun exposure for at least 7 days after discontinuation of treatment. Women of childbearing potential or partners of male patients receiving Alecensa must use highly effective contraceptive methods during treatment & for at least 3 mth following last dose of treatment. Pregnancy & lactation. Ped patients <18 yr.
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