Sorry, you need to enable JavaScript to visit this website.

XALKORI® (crizotinib) Dosage and Administration

2 DOSAGE AND ADMINISTRATION

2.1 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 Clinical Studies (14.1, 14.2)].

Information on FDA-approved tests for the detection of ALK and ROS1 rearrangements in NSCLC is available at http://www.fda.gov/companiondiagnostics.

2.2 Recommended Dosage

The recommended dosage of XALKORI 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.

2.3 Dosage Modifications for Adverse Reactions

The recommended dose reductions 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.

Dosage modifications for adverse reactions for XALKORI are provided in Tables 1 and 2.

Table 1. XALKORI Dosage Modification – Hematologic Toxicities*
Severity of Adverse Reaction XALKORI Dosage Modification
*
Except lymphopenia (unless associated with clinical events, e.g., opportunistic infections).
Grade based on National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 4.0.
Grade 3 Withhold until recovery to Grade 2 or less, then resume at the same dosage
Grade 4 Withhold until recovery to Grade 2 or less, then resume at next lower dosage

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.

Table 2. XALKORI Dosage Modification – Non-Hematologic Toxicities
Severity of Adverse Reaction* XALKORI Dosage Modification
*
Grade based on National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 4.0.
Heart rate less than 60 beats per minute (bpm).
Permanently discontinue for recurrence.
Hepatotoxicity [see Warnings and Precautions (5.1)]
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 until recovery to baseline or less than or equal to 3 times ULN, then resume at next lower dosage.
ALT or AST greater than 3 times ULN with concurrent total bilirubin greater than 1.5 times ULN (in the absence of cholestasis or hemolysis) Permanently discontinue.
Interstitial Lung Disease (Pneumonitis) [see Warnings and Precautions (5.2)]
Any grade drug-related interstitial lung disease/pneumonitis Permanently discontinue.
QT Interval Prolongation [see Warnings and Precautions (5.3)]
QT corrected for heart rate (QTc) greater than 500 ms on at least 2 separate electrocardiograms (ECGs) Withhold until recovery to baseline or to a QTc less than 481 ms, then resume at next lower dosage.
QTc greater than 500 ms or greater than or equal to 60 ms change from baseline with Torsade de pointes or polymorphic ventricular tachycardia or signs/symptoms of serious arrhythmia Permanently discontinue.
Bradycardia [see Warnings and Precautions (5.4)]
Bradycardia (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.
Evaluate concomitant medications known to cause bradycardia, as well as antihypertensive medications.
If contributing concomitant medication is identified and discontinued, or its dose is adjusted, resume at previous dose upon recovery to asymptomatic bradycardia or to a heart rate of 60 bpm or above.
If no contributing concomitant medication is identified, or if contributing concomitant medications are not discontinued or dose modified, resume at reduced dose upon recovery to asymptomatic bradycardia or to a heart rate of 60 bpm or above.
Bradycardia, (life-threatening consequences, 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 at 250 mg once daily upon recovery to asymptomatic bradycardia or to a heart rate of 60 bpm or above, with frequent monitoring.
Severe Vision Loss [see Warnings and Precautions (5.5)]
Visual Loss (Grade 4 Ocular Disorder) Discontinue during evaluation of severe vision loss.

2.4 Dosage Modifications for Moderate and Severe Hepatic Impairment

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 Use in Specific Populations (8.6), Clinical Pharmacology (12.3)].

2.5 Dosage Modification for Severe Renal Impairment

The recommended dosage of XALKORI in patients with severe renal impairment [creatinine clearance (CLcr) less than 30 mL/min, calculated using the modified Cockcroft-Gault equation] not requiring dialysis is 250 mg orally once daily [see Use in Specific Populations (8.7), Clinical Pharmacology (12.3)].

2.6 Dosage Modification for Concomitant Use of Strong CYP3A Inhibitors

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 Drug Interactions (7.1)]. After discontinuation of a strong CYP3A inhibitor, resume the XALKORI dose used prior to initiating the strong CYP3A inhibitor.

What's New

No Current Announcements.

Therapeutic Area

Contact Pfizer Medical

Report an Adverse Event
1-800-438-1985

Search

Please enter your search term(s) for XALKORI®

Contact Pfizer

Need to report an Adverse Event, Side Effect or Product Quality Concern?

Contact Pfizer Safety to report an adverse event, side effect or concern about the quality of a Pfizer product: (800) 438-1985

You may also contact the U.S. Food and Drug Administration (FDA) directly to report adverse events or product quality concerns at 1-800-FDA-1088 or www.fda.gov/MedWatch

Have a Medical Question on a Pfizer Prescription Medicine?
Contact Pfizer Medical Information to speak with a professional regarding your medical question on a Pfizer prescription product: (800) 438-1985
Have a Question on a Pfizer Over-the-Counter Product?
For Pfizer Consumer Healthcare non-prescription or over-the-counter products such as Advil, Centrum, Nexium or Thermacare, call (800) 322-3129
Have a Question about Pfizer Clinical Trials?
If you are looking for information about Pfizer studies currently recruiting new patients in your area, you can begin your search on our website. For questions about a Pfizer Clinical Trial, call (800) 718-1021 or email [email protected]
Need Information on Pfizer’s Patient Assistance Programs?

Pfizer RxPathways® connects eligible patients, regardless of their insurance status, to a range of assistance programs that offer insurance support, co-pay help, and medicines for free or at a savings. For more information, please call (844) 989-7284 or visit www.PfizerRxPathways.com.

Eligible patients can register for valuable savings offers for nearly 40 brand name medications. Visit www.MyPfizerBrands.com for more information.