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DosingSafetyClinical TrialsClinical TrialsXALKORI Clinical TrialsROS1+ NSCLC: PROFILE 1001ALK+ NSCLC: PROFILE 1014

Real World Evidence

Real World EvidenceReal World EvidenceSequential XALKORI® and Ceritinib in ALK+ NSCLCXALKORI® and Post-Progression Treatment in ALK+ NSCLC


The information on this website is based on data from adult patients with ALK (anaplastic lymphoma kinase)-positive / ROS 1-positive advanced NSCLC (non small cell lung cancer) treated with XALKORI®(crizotinib), produced in line with the XALKORI®(crizotinib) Summary of Product Characteristics. XALKORI® (crizotinib) Prescribing Information click here. Adverse event reporting information can be found at the bottom of the page.

XALKORI® Dosing​The recommended dose schedule of XALKORI® is 250 mg twice daily (total daily dose = 500 mg), taken continuously. XALKORI® is taken orally. Capsules should be swallowed whole, preferably with water, and should not be crushed, dissolved or opened.They may be taken with or without food.1 If a dose is missed, then it should be taken as soon as the patient/caregiver 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.1Available DosesXALKORI® is available as a hard capsule formulation in two different strengths to facilitate dose modification.1
  • XALKORI® 200 mg hard capsules
  • XALKORI® 250 mg hard capsules
Dose ModificationsXALKORI® dosing reduction or interruption may be required based on individual safety and tolerability. If a dose reduction is necessary for a patient treated with XALKORI® 250mg orally twice daily then the dose reduction should be as below:XALKORI® dose reduction levels are:1
  • First dose reduction: 200 mg taken orally twice daily (total daily dose = 400 mg)
  • Second dose reduction: 250 mg taken orally once daily (total daily dose = 250 mg)
  • Permanently discontinue: If unable to tolerate XALKORI®250mg taken orally once daily
Dose Modifications for Haematological and Non-haematological Toxicities

 Renal Impairment1
No starting dose adjustment is recommended for patients with mild (60 ≤ creatinine clearance [CLcr] < 90mL/min) or moderate (30 ≤ CLcr <60mL/min) renal impairment. The starting dose should be adjusted to 250mg taken orally once daily in patients with severe renal impairment not requiring peritoneal dialysis ot haemodialysis
Haematological Toxicities*†1
CTCAE Grade XALKORI® Dose Modification
Grade 3 Withhold until recovery to Grade ≤2, then resume at the same dose schedule
Grade 4 Withhold until recovery to Grade ≤2, then resume at the next lower dose‡§

*Except lymphopenia (unless associated with clinical events, e.g. opportunistic infections).
†For patients who develop neutropenia and leukopenia, please refer to the XALKORI® Summary of Product Characteristics.
‡In case of recurrence, dosing should be withheld until recovery to Grade ≤2, then dosing should be resumed at 250 mg once daily. XALKORI® must be permanently discontinue in case of further Grade 4 recurrence.
§For patients treated with 250 mg once daily or whose dose was reduced to 250 mg once daily, discontinue during evaluation. 

Hepatotoxicity1
CTCAE Grade XALKORI® Dose Modification
Grade 3 or 4 ALT or AST elevation with Grade ≤1 total bilirubin Withhold until recovery to Grade ≤1 or baseline, then resume at 250 mg once daily and escalate to 200 mg twice daily if clinically tolerated*†
Grade 2, 3 or 4 ALT or AST elevation with concurrent Grade 2, 3 or 4 total bilirubin elevation (in the absence of cholestasis or haemolysis) Permanently discontinue

Crizotinib is extensively metabolised in the liver. Treatment with Crizotinib should be used with caution in patients with hepatic impairment.
*XALKORI® must be permanently discontinued in case of further Grade ≥3 recurrence. ​​​​For more information, please refer to the XALKORI® Summary of Product Characteristics.†For patients treated with 250 mg once daily or whose dose was reduced to 250 mg once daily, discontinue during evaluation.

Interstitial lung disease (ILD)/Pneumonitis1
CTCAE Grade XALKORI® Dose Modification
Any Grade  Withhold if ILD/pneumonitis is suspected, and permanently discontinue is treatment-related ILD/pneumonitis is diagnosed*

*For more information, please refer to the XALKORI® Summary of Product Characteristics.

QTc Prolongation1
CTCAE Grade XALKORI® Dose Modification
Grade 3 Withhold until recovery to Grade ≤1, check and if necessary correct electrolytes, then resume at the next lower dose*†
Grade 4 Permanently discontinue

*XALKORI® must be permanently discontinued in the case of further Grade ≥3 recurrence. For more information, please refer to the XALKORI® Summary of Product Characteristics.
†For patients treated with 250 mg once daily or whose dose was reduced to 250 mg once daily, discontinue during evaluation.

Bradycardia1
CTCAE Grade XALKORI® Dose Modification
Grade 2, 3 bradycardia*† 
Symptomatic, may be severe and medically significant, medical intervention indicated
Withhold until recovery to Grade ≤1 or to heart rate 60 or above. Evaluate concomitant medicinal products known to cause bradycardia, as well as anti-hypertensive medicinal products.
If contributing concomitant medicinal product is identified and discontinued, or its dose is adjusted, resume at previous dose upon recovery to Grade ≤1 or to heart rate 60 or above.
If no contributing concomitant medicinal products is identified, or if contributing concomitant medicinal products are not discontinued or dose modified, resume at reduced dose§ upon recovery to Grade ≤1 or to heart rate 60 or above.
Grade 4 bradycardia*†‡ 
Life-threatening consequences, urgent intervention indicated
Permanently discontinue if no contributing concomitant medicinal product is identified.
If contributing concomitant medicinal product is identified and discontinued, or its dose is adjusted, resume at 250 mg once daily§ upon recovery to Grade ≤1 or to heart rate 60 or above, with frequent monitoring.

*For more information, please refer to the XALKORI® Summary of Product Characteristics.
†Heart rate less than 60 beats per minute.
‡Permanently discontinue for recurrence.
§For patients treated with 250 mg once daily or whose dose was reduced to 250 mg once daily, discontinue during evaluation.

Visual Effects1
CTCAE Grade XALKORI® Dose Modification
Grade 4 ocular disorder (visual loss)    Discontinue during evaluation of severe vision loss  

For more information on dosing or special warnings and precautions, please refer to the XALKORI® Summary of Product Characteristics.

ALT: alanine aminotransferase, AST: aspartate aminotransferase, CTCAE: national cancer institute common terminology criteria for adverse events, ILD: interstitial lung disease, ULN: upper limit of normalReferenceXALKORI® Summary of Product Characteristics. 
PP-XLK-IRL-0262 February 2024 Legal Category S1A Further information is available on request
XALKORI® Clinical TrialsSafety

Adverse events should be reported. Report an adverse event to your national reporting system (HPRA Pharmacovigilance)
 

Adverse events should also be reported to Pfizer Medical Information on 1800 633 363

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