Medically reviewed on December 12, 2018.
Applies to the following strengths: 250 mg; 200 mg
Usual Adult Dose for:
Additional dosage information:
Usual Adult Dose for Non-Small Cell Lung Cancer
250 mg orally twice a day until disease progression or unacceptable toxicity
Use: For the treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors are anaplastic lymphoma kinase (ALK) or ROS1-positive as detected by an FDA-approved test.
Renal Dose Adjustments
-Mild to moderate renal impairment (CrCl 30 to 89 mL/min): No adjustment recommended.
-Severe renal impairment (CrCl less than 30 mL/min) not requiring dialysis: 250 mg orally once a day
Liver Dose Adjustments
-Mild hepatic impairment (AST greater than upper limit of normal [ULN] and total bilirubin less than or equal to 1 times ULN or any AST and total bilirubin greater than 1 x ULN but less than or equal to 1.5 x ULN): No adjustment recommended.
-Moderate (any AST and total bilirubin greater than 1.5 x ULN and less than or equal to 3 x ULN) or severe (any AST and total bilirubin greater than 3 x ULN) hepatic impairment: Reduce the dose.
Dose Modifications for Adverse Reactions:
-First dose reduction: 200 mg orally twice a day
-Second dose reduction: 250 mg orally once a day
-Permanently discontinue therapy if unable to tolerate 250 mg orally once a day
-Grade 3: Withhold until recovery to Grade 2 or less, then resume at the same dose schedule.
-Grade 4: Withhold until recovery to Grade 2 or less, then resume at next lower dose.
-Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) greater than 5 times upper limit of normal (ULN) with total bilirubin less than or equal to 1.5 times ULN: Withhold therapy until recovery to baseline or less than or equal to 3 x ULN, then resume at next lower dosage.
-ALT or AST elevation greater than 3 x ULN with concurrent total bilirubin elevation greater than 1.5 x ULN (in the absence of cholestasis or hemolysis): Permanently discontinue therapy.
INTERSTITIAL LUNG DISEASE (ILD)/PNEUMONITIS:
-Any grade drug-related ILD/pneumonitis: Permanently discontinue therapy.
-QTc greater than 500 ms on at least 2 separate ECGs: Withhold therapy until recovery to baseline or to a QTc less than 481 ms, then resume at reduced dose.
-QTc greater than 500 ms or greater than or equal to 60 ms change from baseline with Torsade de pointes, polymorphic ventricular tachycardia, or signs/symptoms of serious arrhythmia: Permanently discontinue therapy.
-Symptomatic, may be severe and medically significant, medical intervention indicated: Withhold therapy until recovery to asymptomatic bradycardia or to a heart rate of 60 bpm or above; if concomitant medication contributing to bradycardia is identified and it's discontinued or dose adjusted, resume therapy at previous dose; if no contributing medication is identified or that medication is not discontinued or dose adjusted, resume therapy at a reduced dose upon recovery to asymptomatic bradycardia or to a heart rate of 60 bpm or above.
-Life-threatening, urgent intervention indicated: Permanently discontinue therapy if no contributing concomitant medication is identified. If contributing concomitant medication is identified and discontinued or its dose is adjusted, resume therapy at 250 mg once a day with frequent monitoring. In case of recurrence, permanently discontinue therapy.
SEVERE VISION LOSS (GRADE 4 OCULAR DISORDER): Discontinue therapy during evaluation of severe vision loss.
Dosage Modification for Concomitant Use of Strong CYP450 3A Inhibitors:
-Avoid concomitant use of strong CYP450 3A inhibitors; if concomitant use is unavoidable, reduce the dose of crizotinib to 250 mg orally once daily.
-After discontinuation of a strong CYP450 3A inhibitor, resume the crizotinib dose used 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
-Take with or without food.
-Swallow capsules whole.
-Make up a missed dose unless the next dose is due within 6 hours.
-If vomiting occurs after taking a dose, take the next dose at the regular time.
-Preparation, handling, and disposal of this drug should be performed in a manner consistent with safe procedures for cytotoxic agents.
-Selection of patients is based on the presence of anaplastic lymphoma kinase (ALK) positivity in tumor specimens as detected by a well-validated test.
-Monitor complete blood counts including differential white blood cell counts monthly and as clinically indicated, with more frequent repeat testing if CTCAE Grade 3 or 4 abnormalities are observed, or if fever or infection occurs.
-Monitor heart rate and blood pressure regularly, at least monthly.
-Obtain ECGs and electrolytes as close as possible prior to the first dose and periodic monitoring in patients with congestive heart failure, bradyarrhythmias, electrolyte abnormalities, history or predisposition for QTc prolongation, and taking medications that prolong the QT interval.
-Monitor with liver function tests including ALT, AST, and total bilirubin once a week during the first 2 months of treatment, then once a month and as clinically indicated.
-Monitor patients for pulmonary symptoms indicative of interstitial lung disease (ILD)/pneumonitis.
-Fetal harm may occur with this drug; avoid pregnancy during therapy. Women of childbearing potential and men who take this drug should use birth control during therapy and for at least 3 months after.
-If pregnancy occurs, contact your doctor immediately.
-This drug may cause serious side effects including liver, lung, heart, and vision problems. Tell your doctor if you have any side effect that bothers you or does not go away.
-Tell your doctor about all the medications you take, including prescription and over-the-counter drugs, vitamins, dietary and herbal supplements, so possible interactions can be evaluated.
-Do not drink grapefruit juice or eat grapefruit while taking this drug as it may increase the drug amount in your blood to a harmful level.
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
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- Drug class: multikinase inhibitors
Other brands: Xalkori