Medically reviewed by Drugs.com. Last updated on May 1, 2023.
Applies to the following strengths: 150 mg
Usual Adult Dose for:
Additional dosage information:
Usual Adult Dose for Non-Small Cell Lung Cancer
450 mg orally once daily at the same time each day until disease progression or unacceptable toxicity
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 (Child-Pugh A or B): No adjustment recommended.
Severe hepatic impairment (Child-Pugh C): Reduce dose by approximately one-third, rounded to the nearest multiple of the 150 mg dose strength.
- First dose reduction: 300 mg once a day
- Second dose reduction: 150 mg once a day
- Discontinue this drug in patients unable to tolerate 150 mg daily.
DOSE MODIFICATIONS FOR ADVERSE REACTIONS:
GI ADVERSE REACTIONS:
- Severe or intolerable nausea, vomiting, or diarrhea despite antiemetic or antidiarrheal therapy: Withhold therapy until improved; resume at the next lower dose.
- ALT or AST elevation greater than 5 times upper limit of normal (ULN) with total bilirubin elevation less than or equal to 2 x ULN: Withhold therapy until recovery to baseline or less than or equal to 3 x ULN; resume at the next lower dose.
- ALT or AST elevation greater than 3 x ULN with total bilirubin elevation greater than 2 x ULN in the absence of cholestasis or hemolysis: Permanently discontinue therapy.
- Any Grade therapy-related ILD/pneumonitis: Permanently discontinue therapy.
- QTc interval greater than 500 msec on at least 2 separate ECGs: Withhold therapy until QTc interval is less than 481 msec or recovery to baseline if baseline QTc is greater than or equal to 481 msec; resume at the next lower dose.
- QTc interval prolongation in combination with Torsades de pointes or polymorphic ventricular tachycardia or serious arrhythmia: Permanently discontinue therapy.
- Persistent hyperglycemia greater than 250 mg/dL despite antihyperglycemic therapy: Withhold therapy until hyperglycemia is adequately controlled; resume at the next lower dose; if adequate hyperglycemic control cannot be achieved with medical management, discontinue this drug.
- Symptomatic bradycardia that is not life-threatening: Withhold therapy until recovery to asymptomatic bradycardia or to heart rate of 60 bpm or above, evaluate concomitant medications known to cause bradycardia; if bradycardia cannot be attributed to another drug, resume therapy at the next lower dose.
- Clinically significant bradycardia requiring intervention or life-threatening bradycardia in patients taking a concomitant medication also known to cause bradycardia or a medication known to cause hypotension: Permanently discontinue therapy.
- Lipase or amylase elevation greater than 2 x ULN: Withhold therapy until recovery to less than 1.5 x ULN; resume at the next lower dose.
STRONG CYP450 3A INHIBITORS (e.g. ketoconazole):
- Avoid use if possible.
- If use cannot be avoided, reduce dose of ceritinib by approximately one-third rounded to the nearest multiple of the 150 mg.
- After discontinuation of a strong CYP450 3A inhibitor, resume the ceritinib dose that was taken prior to initiating the strong CYP450 3A inhibitor.
Safety and efficacy have not been established in patients younger than 18 years.
Consult WARNINGS section for additional precautions.
Data not available
- This drug should be taken with food.
- Do not consume grapefruit or grapefruit juice because they inhibit CYP450 3A.
- 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.
- Store at 20C to 25C (68F to 77F); excursions permitted between 15C to 30C (59F to 86F).
- Select patients for treatment of metastatic NSCLC with this drug based on the presence of ALK positivity in tumor specimens.
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