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Monitor and manage patients using standard of care, including antidiarrheals, antiemetics, or fluid replacement, as indicated. Withhold Ceritinib if gastrointestinal adverse reaction is severe or intolerable and is not responsive to antiemetics or antidiarrheals. Upon improvement, resume Ceritinib at a reduced dose.
Monitor with liver laboratory tests, including ALT, AST, and total bilirubin, once a month and as clinically indicated, with more frequent testing in patients who develop transaminase elevations. Based on the severity of the adverse reaction, withhold Ceritinib with resumption at a reduced dose, or permanently discontinue Ceritinib.
Monitor patients for pulmonary symptoms indicative of ILD/pneumonitis. Exclude other potential causes of ILD/pneumonitis and permanently discontinue Ceritinib in patients diagnosed with treatment-related ILD/pneumonitis.
When possible, avoid use of Ceritinib in patients with congenital long QT syndrome. Conduct periodic monitoring with ECGs and electrolytes in patients with congestive heart failure, bradyarrhythmias, electrolyte abnormalities, or those who are taking medications that are known to prolong the QTc interval. Based on the severity of the adverse reaction, withhold Ceritinib, with resumption at a reduced dose, or permanently discontinue Ceritinib.
Monitor fasting serum glucose prior to the start of Ceritinib treatment and periodically thereafter as clinically indicated. Initiate or optimize anti-hyperglycemic medications as indicated. Based on the severity of the adverse reaction, withhold Ceritinib with resumption at a reduced dose, or permanently discontinue Ceritinib.
from FDA，2021.10
