Applies to the following strength(s): 150 mg
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Usual Adult Dose for:
Additional dosage information:
Usual Adult Dose for Non-Small Cell Lung Cancer
750 mg orally once daily on an empty stomach.
Duration of therapy: Until disease progression or unacceptable toxicity
-If a dose is missed, make it up unless it is 12 hours or less until the next dose.
-Discontinue in patients unable to tolerate 300 mg a day.
-An improvement in survival or disease-related symptoms has not been established
Use: Treatment of patients with anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer (NSCLC) who have progressed on or are intolerant to crizotinib.
Renal Dose Adjustments
Mild to moderate renal impairment (CrCl 30 to less than 90 mL/min): No adjustment recommended.
Severe renal impairment (CrCl less than 30 mL/min): Data not available
Liver Dose Adjustments
Mild hepatic impairment: No dose adjustment.
Moderate to severe hepatic impairment: Data not available.
Monitor liver tests including ALT, AST, and bilirubin once a month and as clinically indicated.
If during treatment ALT or AST is greater than 5 times ULN and bilirubin is 2 times ULN or less:
-Withhold until return to baseline or until 3 times or less ULN, resume at 150 mg less than previous dose.
If during treatment ALT or AST is greater than 3 times ULN and bilirubin is greater than 2 times ULN (in the absence of cholestasis or hemolysis):
-Permanently discontinue drug.
Strong CYP450 3A4 Inhibitors
Strong CYP450 3A inhibitors (e.g. ketoconazole):
-If use cannot be avoided, reduce dose of ceritinib by approximately one third.
-Resume previous dose of ceritinib after discontinuation of strong CYP450 3A inhibitor.
QTc interval prolongation:
QTc interval greater than 500 msec on 2 separate ECGs:
-Withhold until QTc interval is less than 481 msec or recovery to baseline, whichever is higher, then resume ceritinib with a 150 mg dose reduction.
QTc interval prolongation with one of the following: Torsade de pointes, polymorphic ventricular tachycardia, or signs/symptoms of serious arrhythmia:
GI side effects:
Severe/intolerable nausea, vomiting, or diarrhea despite optimal therapy:
-Withhold until improved, then resume with a 150 mg dose reduction.
Persistent hyperglycemia (greater than 250 mg/dL) despite optimal therapy:
-Withhold until hyperglycemia is adequately controlled, then resume with a 150 mg dose reduction.
-If adequate glycemic control cannot be achieved with optimal medical management, discontinue.
Non-life threatening symptomatic bradycardia:
-Withhold until recovery to asymptomatic bradycardia or to a heart rate of 60 bpm or above, evaluate concomitant medications known to cause bradycardia, and adjust the dose of ceritinib.
Life threatening or intervention requiring bradycardia in patients on other medications known to cause bradycardia or hypotension:
-Withhold until recovery to asymptomatic bradycardia or to a heart rate of 60 bpm or above. If the concomitant medication can be adjusted or discontinued, resume ceritinib with a 150 mg dose reduction, with frequent monitoring.
Life threatening bradycardia in patients not on medications known to cause bradycardia or hypotension:
Interstitial Lung Disease (ILD)/Pneumonitis:
-Permanently discontinue for any grade of treatment related ILD/pneumonitis or any symptoms of ILD/pneumonitis if other causes cannot be excluded.
Data not available
-Do not take within 2 hours of a meal.
-Do not consume grapefruit or grapefruit juice.
More about ceritinib
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Other brands: Zykadia