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XALKORI is a brand name for Crizotinib, supplied as a capsule. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: XALKORI (crizotinib) is indicated for • use as monotherapy in patients with anaplastic lymphoma kinase (ALK)-positive locally advanced (not amenable to curative therapy) or metastatic non-small cell lung cancer (NSCLC). • use in patients with ROS1-positive locally advanced (not amenable to curative therapy) or…
Verbatim from this product's HC label. Tap a section to expand.
1 Dosing Considerations ALK or ROS1 Testing Prior to receiving therapy with XALKORI, patients must be tested and confirmed for either ALK-positive or ROS1-positive locally advanced or metastatic NSCLC using a validated ALK or ROS1 assay, respectively (see 14 CLINICAL TRIALS).
Assessment for ALK-positive or ROS1-positive locally advanced or metastatic NSCLC should be performed by laboratories with demonstrated proficiency in the specific technology being utilized. Improper assay performance can lead to unreliable test results.
2 Recommended Dose and Dosage Adjustment The recommended dose schedule of XALKORI (crizotinib) is 250 mg taken orally twice daily with or without food. Treatment should be continued as long as the patient is deriving clinical benefit from therapy.
5×ULN and ≤3×ULN), the starting XALKORI dose is recommended to be 200 mg twice daily. For patients with severe hepatic impairment (any AST and total bilirubin >3×ULN), the starting XALKORI dose is recommended to be 250 XALKORI (crizotinib) Page 6 of 63 mg once daily.
The starting dose of XALKORI should be 250 mg once daily in patients with severe renal impairment (CLcr < 30 mL/min) not requiring peritoneal dialysis or hemodialysis. Dose Modification Dose reduction and/or treatment interruption may be required based on individual safety and tolerability.
The recommended dose reductions for patients treated with XALKORI 250 mg orally twice daily 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 Dose modification guidelines for hematologic and non-hematologic toxicities are provided in Tables 1 and 2.
For dose modifications in patients treated with a XALKORI dose lower than 250 mg twice daily, follow the recommendations in Table 1 and Table 2 accordingly. Table 1. XALKORI Dose Modification – Hematologic Toxicitiesa CTCAEb Grade XALKORI Dosing 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 dosec,d a.
, opportunistic infections) b. NCI Common Terminology Criteria for Adverse Events c. In case of recurrence, withhold until recovery to Grade <2 or baseline, then resume at 250 mg taken orally once daily. Permanently discontinue in case of further Grade 4 recurrence.
). • Patients with a known hypersensitivity to the active substance, crizotinib, or to any ingredient in the formulation or component of the container. For a complete listing, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING.
XALKORI (crizotinib) Page 5 of 63 3 SERIOUS WARNINGS AND PRECAUTIONS BOX Serious Warnings and Precautions • QT interval prolongation and bradycardia. (See 7 WARNINGS AND PRECAUTIONS, Cardiovascular; 8 ADVERSE REACTIONS) • Hepatotoxicity, including fatal outcomes.
(See 7 WARNINGS AND PRECAUTIONS, Hepatic, Biliary/Pancreatic; 8 ADVERSE REACTIONS) • Interstitial Lung Disease (Pneumonitis), including fatal cases. (See 7 WARNINGS AND PRECAUTIONS, Respiratory, 8 ADVERSE REACTIONS) • Vision loss which may be severe (See 7 WARNINGS AND PRECAUTIONS, Ophthalmologic) • XALKORI has not been studied in patients with severe renal impairment requiring peritoneal dialysis or hemodialysis.
(See 7 WARNINGS AND PRECAUTIONS, Renal, 8 ADVERSE REACTIONS) XALKORI (crizotinib) should only be prescribed and supervised by a qualified physician experienced in the use of anticancer agents. 1 Dosing Considerations ALK or ROS1 Testing Prior to receiving therapy with XALKORI, patients must be tested and confirmed for either ALK-positive or ROS1-positive locally advanced or metastatic NSCLC using a validated ALK or ROS1 assay, respectively (see 14 CLINICAL TRIALS).
Assessment for ALK-positive or ROS1-positive locally advanced or metastatic NSCLC should be performed by laboratories with demonstrated proficiency in the specific technology being utilized. Improper assay performance can lead to unreliable test results.
2 Recommended Dose and Dosage Adjustment The recommended dose schedule of XALKORI (crizotinib) is 250 mg taken orally twice daily with or without food. Treatment should be continued as long as the patient is deriving clinical benefit from therapy.
• Patients with congenital long QT syndrome or with a persistent Fridericia-corrected electrocardiogram interval (QTcF) of ≥500 msec (see 7 WARNINGS AND PRECAUTIONS, 8 ADVERSE REACTIONS). • Patients with a known hypersensitivity to the active substance, crizotinib, or to any ingredient in the formulation or component of the container.
For a complete listing, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING. XALKORI (crizotinib) Page 5 of 63
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d. For patients treated with 250 mg once daily or whose dose was reduced to 250 mg once daily, discontinue during evaluation. Table 2. XALKORI Dose Modification – Non-Hematologic Toxicities CTCAEa Grade XALKORI Dosing Grade 3 or 4 ALT or AST elevation with Grade <1 total bilirubin Withhold until recovery to Grade 1 or baseline, then resume at the next lower doseb,c 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 hemolysis) Permanently discontinue Any grade interstitial lung disease/pneumonitisd Permanently discontinue Grade 3 QTc prolongation (≥500 msec) Withhold until recovery to Grade <1 (≤ 470 msec), then resume at the next lower doseb,c Grade 4 QTc prolongation (≥500 msec [or >60 msec change from baseline] and Torsade de Pointes or Permanently discontinue XALKORI (crizotinib) Page 7 of 63 polymorphic ventricular tachycardia, or signs/symptoms of serious arrhythmias) Grade 2, 3 Bradycardiae (symptomatic, may be severe and medically significant, medical intervention indicated) Withhold until recovery to Grade ≤ 1 or to heart rate of 60 bpm or above Evaluate concomitant medications known to cause bradycardia, as well as anti-hypertensive medications If contributing concomitant medication is identified and discontinued, or its dose is adjusted, resume at previous dose upon recovery to Grade ≤ 1 or to 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 Grade ≤ 1 or to heart rate of 60 bpm or above Grade 4 Bradycardiae,f (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 Grade ≤ 1 or to heart rate of 60 bpm or above, with frequent monitoring Grade 4 Visual Loss Discontinue during evaluation of severe vision loss a.
NCI Common Terminology Criteria for Adverse Events b. In case of recurrence, withhold until recovery to Grade <1 or baseline, then resume at 250 mg taken orally once daily. Permanently discontinue in case of further Grade 3 or 4 recurrence.
c. For patients treated with 250 mg once daily or whose dose was reduced to 250 mg once daily, discontinue during evaluation. d. In the absence of NSCLC progression, other pulmonary disease, infection, or radiation effect e. Heart rate less than 60 beats per minute (bpm).
f. Permanently discontinue for recurrence. QT Interval Prolongation In the event of a QTc of ≥500 msec (Grade 3), dosing with XALKORI should be withheld until recovery to Grade ≤1 (≤470 msec), then resumed at a reduced dose of 200 mg twice daily.
Permanent discontinuation of XALKORI is recommended in the event of a Grade 4 QTc prolongation (≥500 msec [or >60 msec change from baseline] and Torsade de Pointes or polymorphic ventricular tachycardia, or signs/symptoms of serious arrhythmias).
Machine-read QTc measurements may not be […]
5×ULN and ≤3×ULN), the starting XALKORI dose is recommended to be 200 mg twice daily. For patients with severe hepatic impairment (any AST and total bilirubin >3×ULN), the starting XALKORI dose is recommended to be 250 XALKORI (crizotinib) Page 6 of 63 mg once daily.
The starting dose of XALKORI should be 250 mg once daily in patients with severe renal impairment (CLcr < 30 mL/min) not requiring peritoneal dialysis or hemodialysis. Dose Modification Dose reduction and/or treatment interruption may be required based on individual safety and tolerability.
The recommended dose reductions for patients treated with XALKORI 250 mg orally twice daily 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 Dose modification guidelines for hematologic and non-hematologic toxicities are provided in Tables 1 and 2.
For dose modifications in patients treated with a XALKORI dose lower than 250 mg twice daily, follow the recommendations in Table 1 and Table 2 accordingly. Table 1. XALKORI Dose Modification – Hematologic Toxicitiesa CTCAEb Grade XALKORI Dosing 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 dosec,d a.
, opportunistic infections) b. NCI Common Terminology Criteria for Adverse Events c. In case of recurrence, withhold until recovery to Grade <2 or baseline, then resume at 250 mg taken orally once daily. Permanently discontinue in case of further Grade 4 recurrence.
d. For patients treated with 250 mg once daily or whose dose was reduced to 250 mg once daily, discontinue during evaluation. Table 2. XALKORI Dose Modification – Non-Hematologic Toxicities CTCAEa Grade XALKORI Dosing Grade 3 or 4 ALT or AST elevation with Grade <1 total bilirubin Withhold until recovery to Grade 1 or baseline, then resume at the next lower doseb,c 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 hemolysis) Permanently discontinue Any grade interstitial lung disease/pneumonitisd Permanently discontinue Grade 3 QTc prolongation (≥500 msec) Withhold until recovery to Grade <1 (≤ 470 msec), then resume at the next lower doseb,c Grade 4 QTc prolongation (≥500 msec [or >60 msec change from baseline] and Torsade de Pointes or Permanently discontinue XALKORI (crizotinib) Page 7 of 63 polymorphic ventricular tachycardia, or signs/symptoms of serious arrhythmias) Grade 2, 3 Bradycardiae (symptomatic, may be severe and medically significant, medical intervention indicated) Withhold until recovery to Grade ≤ 1 or to heart rate of 60 bpm or above Evaluate concomitant medications known to cause bradycardia, as well as anti-hypertensive medications If contributing concomitant medication is identified and discontinued, or its dose is adjusted, resume at previous dose upon recovery to Grade ≤ 1 or to 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 Grade ≤ 1 or to heart rate of 60 bpm or above Grade 4 Bradycardiae,f (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 Grade ≤ 1 or to heart rate of 60 bpm or above, with frequent […]