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Real World Evidence
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.
| 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.
| 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.
| 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.
| 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.
| 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.
| 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.
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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