• Assess for signs/symptoms of ILD or pneumonitis (trouble breathing, shortness of breath, fever, cough with or without mucus, chest pain). If ILD or pneumonitis occurs, permanently discontinue ceritinib.
• Monitor ECG periodically during therapy. If QTc interval >500 msec on >2 separate ECGs, hold ceritinib until QTc interval <481 msec or recovery to baseline if QTc ≥481 msec, then resume ceritinib with a 150-mg dose ↓. If QTc interval prolongation occurs in combination with torsades de pointes or polymorphic ventricular tachycardia or signs/symptoms of serious arrhythmia, permanently discontinue ceritinib.
  • If symptomatic bradycardia that is not life-threatening occurs, hold ceritinib until recovery to asymptomatic bradycardia or HR ≥60 bpm, evaluate concurrent medications causing bradycardia, and adjust dose of ceritinib. If clinically significant bradycardia requiring intervention or life-threatening bradycardia in patients taking concurrent medication known to cause bradycardia or a medication known to cause hypotension occurs, hold ceritinib until recovery to asymptomatic bradycardia or HR ≥60 bpm. If concurrent medication can be adjusted or discontinued, resume ceritinib with a 150-mg dose ↓ and frequent monitoring. If life-threatening bradycardia occurs in patients not taking medications known to cause bradycardia or hypotension, permanently discontinue ceritinib.
• Assess for nausea, vomiting, or diarrhea. If severe or intolerable nausea, vomiting, or diarrhea continue despite optimal antiemetic or antidiarrheal therapy, hold ceritinib until improved; then resume with a 150-mg dose ↓.

Lab Test Considerations:

• Test patient for ALK positivity in tumor specimens through an FDA-approved test prior to starting therapy.
  • Monitor liver function tests at least monthly. If ALT or AST >5 times upper limit of normal (ULN) and total bilirubin ≤2 times ULN, hold ceritinib until recovery to baseline or ≤3 times ULN, then resume ceritinib with a 150-mg dose ↓. If ALT or AST >3 times ULN and total bilirubin >2 times ULN in the absence of cholestasis or hemolysis, permanently discontinue ceritinib.
  • Monitor fasting blood glucose prior to and periodically during therapy. If persistent glucose >250 mg/dL despite antihyperglycemic therapy, hold ceritinib until hyperglycemia is adequately controlled, then resume with a 150-mg dose ↓. If adequate hyperglycemic control cannot be achieved, discontinue therapy.
  • May ↓ hemoglobin and serum phosphate; may ↑ creatinine.
  • Monitor lipase and amylase prior to and periodically during therapy. May ↑ lipase and amylase. If lipase or amylase >2 times ULN, hold ceritinib and monitor lipase and amylase. When lipase and amylase <1.5 times ULN, resume ceritinib with a 150-mg dose ↓.