Applies to the following strength(s): 250 mg ; 200 mg
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Usual Adult Dose for:
Additional dosage information:
Usual Adult Dose for Non-Small Cell Lung Cancer
250 mg orally twice a day
Use: Metastatic non-small cell lung cancer whose tumors are anaplastic lymphoma kinase-positive
Renal Dose Adjustments
Severe renal impairment (CrCl less than 30 mL/min) not requiring dialysis: 250 mg orally once a day
Liver Dose Adjustments
Use with caution as hepatic impairment is likely to increase plasma concentrations of the drug.
CTCAE Grade 3 or 4 Adverse Reactions:
-First dose reduction: 200 mg orally twice a day
-Second dose reduction: 250 mg orally once a day
-Permanently discontinue if patient unable to tolerate 250 mg once a day
-CTCAE Grade 3: Withhold until recovery to Grade 2 or less, then resume at the same dose schedule.
-CTCAE Grade 4: Withhold until recovery to Grade 2 or less, then resume at next lower dose.
- ALT or AST elevation greater than 5 times upper limit of normal (ULN) with total bilirubin less than or equal to 1.5 times ULN: Withhold until recovery to baseline or 3 times ULN or less, then resume at reduced dose.
- ALT or AST elevation greater than 3 times ULN with concurrent total bilirubin elevation greater than 1.5 times ULN (in the absence of cholestasis or hemolysis): Permanently discontinue.
-QTc greater than 500 ms on at least 2 separate ECGs: Withhold 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.
-Symptomatic, may be severe and medically significant, medical intervention indicated:
Withhold 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 crizotinib at previous dose; if no contributing medication is identified or that medication is not discontinued or dose adjusted, resume crizotinib at a reduced dose.
-Life-threatening, urgent intervention indicated: Permanently discontinue if no contributing concomitant medication is identified. If contributing concomitant medication is identified and discontinued or its dose is adjusted, resume crizotinib at 250 mg once a day with frequent monitoring. In case of recurrence, permanently discontinue.
Interstitial Lung Disease (ILD)/Pneumonitis:
-Any grade drug-related ILD/pneumonitis: Permanently discontinue.
-Hematologic toxicities do not include lymphopenia unless associated with clinical events such as opportunistic infections.
-Severity of adverse reactions defined by National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE)
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.
-Tests should be FDA-approved. Information on FDA-approved tests available at www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/InVitroDiagnostics/ucm301431.htm. (US)
-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 liver disease/pneumonitis.
-Fetal harm may occur with this drug; avoid pregnancy during treatment. Women who are able to become pregnant and men who take this drug should use birth control during treatment and for at least 3 months after stopping treatment. 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.
More about crizotinib
- Other brands: Xalkori