Xalkori Dosage/Direction for Use

Patient Selection: Select patients for the treatment of metastatic NSCLC with XALKORI based on the presence of ALK or ROS1 positivity in tumor specimens [see Pharmacology: Pharmacodynamics: Clinical Studies: ALK-Positive Metastatic NSCLC and ROS1-Positive Metastatic NSCLC under Actions].
ALK and ROS1 Testing: An accurate and validated assay for either ALK or ROS1 is necessary for the selection of patients for treatment with XALKORI [see Pharmacology: Pharmacodynamics: Clinical Studies under Actions].
Either ALK-positive or ROS1-positive NSCLC status should be established prior to initiation of Crizotinib therapy.
Assessment should be performed by laboratories with demonstrated proficiency in the specific technology being utilized [see Precautions].
Recommended Dosing for ALK- or ROS1-Positive Metastatic Non Small Cell Lung Cancer: The recommended dose of XALKORI for patients with NSCLC is 250 mg orally, twice daily, with or without food, until disease progression or no longer tolerated by the patient.
Swallow capsules whole. If a dose of XALKORI is missed, make up that dose unless the next dose is due within 6 hours. If vomiting occurs after taking a dose of XALKORI, take the next dose at the regular time.
Dosage Modifications for Adverse Reactions: Recommended Dosage Reductions: ALK- or ROS1-positive metastatic NSCLC: The recommended dose reductions for adverse reactions in patients with metastatic NSCLC are: First dose reduction: XALKORI 200 mg taken orally twice daily.
Second dose reduction: XALKORI 250 mg taken orally once daily.
Permanently discontinue if unable to tolerate XALKORI 250 mg taken orally once daily.
Recommended Dosage Modifications for Patients with NSCLC: Recommended dosage modifications for hematologic and non-hematologic adverse reactions for patients with NSCLC are provided in Tables 4 and 5. (See Table 4.)

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Monitor complete blood counts including differential white blood cell counts monthly and as clinically indicated, with more frequent repeat testing if Grade 3 or 4 abnormalities are observed, or if fever or infection occurs. (See Table 5.)

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Dosage Modifications for Moderate and Severe Hepatic Impairment: ALK- or ROS1-positive metastatic NSCLC: The recommended dose of XALKORI in patients with pre-existing moderate hepatic impairment [any aspartate aminotransferase (AST) and total bilirubin greater than 1.5 times the upper limit of normal (ULN) and less than or equal to 3 times ULN] is 200 mg orally twice daily.
The recommended dose of XALKORI in patients with pre-existing severe hepatic impairment (any AST and total bilirubin greater than 3 times ULN) is 250 mg orally once daily [see Hepatic Impairment under Precautions and Pharmacology: Pharmacokinetics under Actions].
Dosage Modification for Severe Renal Impairment: ALK- or ROS1-positive metastatic NSCLC: The recommended dosage of XALKORI in patients with severe renal impairment [creatinine clearance (CL_cr) less than 30 mL/min, calculated using the modified Cockcroft-Gault equation] not requiring dialysis is 250 mg orally once daily [see Renal Impairment under Precautions and Pharmacology: Pharmacokinetics under Actions].
Dosage Modification for Concomitant Use of Strong CYP3A Inhibitors: ALK- or ROS1-positive metastatic NSCLC: Avoid concomitant use of strong CYP3A inhibitors. If concomitant use of strong CYP3A inhibitors is unavoidable, reduce the dose of XALKORI to 250 mg orally once daily [see Effect of Other Drugs on XALKORI under Interactions]. After discontinuation of a strong CYP3A inhibitor, resume the XALKORI dose used prior to initiating the strong CYP3A inhibitor.