Crizotinib Dosage

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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.

Renal Dose Adjustments

Mild to Moderate renal impairment (creatinine clearance 30 to 90 mL/min): No initial dose adjustment is needed.
Severe renal impairment (creatinine clearance less than 30 mL/min) not requiring dialysis: Administer a starting dose of 250 mg orally once a day.

Liver Dose Adjustments

Crizotinib has not been studied in patients with hepatic impairment. Caution should be used when treating patients with hepatic impairment.

Dose Adjustments

Dosing interruption and/or dose reduction may be required based on individual safety and tolerability. If dose reduction is necessary, then the dose of crizotinib should be reduced to 200 mg taken orally twice daily. If further dose reduction is necessary, then reduce the dosage to 250 mg taken orally once daily based on individual safety and tolerability.

HEMATOLOGIC TOXICITY:
For CTC-AE Grade 3 hematologic toxicities, withhold crizotinib until recovery to Grade 2 or less, then resume at the same dose schedule.

For Grade 4 hematologic toxicities, withhold crizotinib until recovery to Grade 2 or less, then resume at 200 mg twice daily.

LIVER FUNCTION ELEVATIONS, QTC PROLONGATION or PNEUMONITIS:
For Grade 3 or 4 alanine aminotransferase (ALT) or aspartate aminotransferase (AST) elevation with Grade 1 or less total bilirubin, or for Grade 3 QTc prolongation, withhold until recovery to Grade 1 or less, then resume crizotinib at 200 mg twice daily.

For Grade 2,3 or 4 ALT or AST elevation with Grade 2, 3 or 4 total bilirubin elevation (in the absence of cholestasis or hemolysis) or for any Grade pneumonitis, or for Grade 4 QTc prolongation, permanently discontinue crizotinib.

BRADYCARDIA:
For Grade 2 or 3 bradycardia, withhold until recovery to Grade 1 or less, evaluate concomitant medications, then resume at 200 mg twice daily.

For Grade 4 bradycardia, permanently discontinue.

No dosage adjustment is recommended based on gender, weight, or geriatric status.

Precautions

Severe, life-threatening, or fatal treatment-related pneumonitis was observed in 1.6% of patients in crizotinib clinical trials. All cases occurred within 2 months after the initiation of treatment. Monitor patients for pulmonary symptoms indicative of pneumonitis. Permanently discontinue crizotinib in patients diagnosed with treatment-related pneumonitis.

Hepatic laboratory abnormalities have occurred in patients on crizotinib including Grade 3 or 4 alanine aminotransferase (ALT) elevations in up to 7% of patients in clinical trials. These elevations were generally asymptomatic and reversible upon dosing interruption. Concurrent elevations in ALT and total bilirubin without elevated alkaline phosphatase were also observed. Monitoring of liver functions tests including ALT and total bilirubin is recommended once a month and as clinically indicated. Repeat testing for Grades 2 to 4 transaminase elevations should be performed more frequently.

QTc prolongation has been observed in patients taking crizotinib. Crizotinib should be avoided in patients with congenital long QT syndrome. In patients with congestive heart failure, bradyarrhythmia, electrolyte abnormalities, or who have a known history or predisposition for QTC prolongation, or are taking medications that are known to prolong the QT interval, routine monitoring with electrocardiograms (ECGs) and electrolytes is recommended. Permanently discontinue crizotinib in patients who develop Grade 4 QTc prolongation or Grade 3 QTc prolongation that does not resolve with dose interruption and modification.

Safety and effectiveness have not been established in pediatric patients (less than 18 years of age).

Dialysis

Data not available.

Other Comments

Continue treatment as long as the patient is deriving clinical benefit from therapy.

Capsules should be swallowed whole. Crizotinib may be taken with or without food. If a dose of crizotinib is missed, then it should be taken as soon as the patient remembers unless it is less than 6 hours until the next dose, in which case the patient should not take the missed dose. Patients should not take two doses at the same time to make up for a missed dose.

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