Xalkori
INDICATIONS
XALKORI is indicated for the treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) that is anaplastic lymphoma kinase (ALK)-positive as detected by an FDA-approved test.
This indication is based on response rate. There are no data available demonstrating improvement in patient reported outcomes or survival with XALKORI.
DOSAGE AND ADMINISTRATION
Recommended Dosing
The recommended dose and schedule of XALKORI is 250 mg taken orally twice daily. Continue treatment as long as the patient is deriving clinical benefit from therapy. XALKORI may be taken with or without food. Swallow capsules whole. If a dose of XALKORI is missed, make up that dose unless the next dose is due within 6 hours.
Dose Modification
Dosing interruption and/or dose reduction may be required based on individual safety and tolerability. If dose reduction is necessary, then reduce the dose of XALKORI to 200 mg taken orally twice daily. If further dose reduction is necessary, then reduce the dosage to 250 mg taken orally once daily based on individual safety and tolerability. Dose reduction guidelines for hematologic and non-hematologic toxicities are provided in Tables 1 and 2.
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 200 mg twice dailyc |
| a Except lymphopenia (unless associated with
clinical events, e.g., opportunistic infections). b NCI Common Terminology Criteria for Adverse Events. c In case of recurrence, withhold until recovery to Grade ≤ 2, then resume at 250 mg once daily. Permanently discontinue in case of further Grade 4 recurrence. |
|
Table 2: XALKORI Dose Modification - Non-Hematologic Toxicities
| CTCAE Grade | XALKORI Dosing |
| Grade 3 or 4 alanine aminotransferase (ALT) or aspartate aminotransferase (AST) elevation with Grade ≤ 1 total bilirubin | Withhold until recovery to Grade ≤ 1 or baseline, then resume at 200 mg twice dailya |
| 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 pneumonitisb | Permanently discontinue |
| Grade 3 QTc prolongation | Withhold until recovery to Grade ≤ 1, then resume at 200 mg twice dailya |
| Grade 4 QTc prolongation | Permanently discontinue |
| a In case of recurrence, withhold until recovery
to Grade ≤ 1, then resume at 250 mg once daily. Permanently discontinue
in case of further Grade 3 or 4 recurrence. b Not attributable to NSCLC progression, other pulmonary disease, infection, or radiation effect. |
|
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. Monitor liver function tests monthly and as clinically indicated, with more frequent repeat testing if Grade 2, 3 or 4 abnormalities are observed.
HOW SUPPLIED
Dosage Forms and Strengths
250 mg capsules
Hard gelatin capsule, size 0, pink opaque cap and body, with "Pfizer" on the cap and "CRZ 250" on the body.
200 mg capsules
Hard gelatin capsule, size 1, white opaque body and pink opaque cap, with "Pfizer" on the cap and "CRZ 200" on the body.
250 mg capsules
Hard gelatin capsule with pink opaque cap and body, printed with black ink "Pfizer" on the cap, "CRZ 250" on the body; available in:
Bottles of 60 capsules: NDC 0069-8140-20
200 mg capsules
Hard gelatin capsule with pink opaque cap and white opaque body, printed with black ink "Pfizer" on the cap, "CRZ 200" on the body; available in:
Bottles of 60 capsules: NDC 0069-8141-20
Store at room temperature 20 °to25°C (68 ° to 77 °F); excursions permitted between 15 ° to 30 °C (59 ° to 86 °F) [see USP Controlled Room Temperature].
Distributed by: Pfizer Labs, Di»isnn at Pfizer Inc. NY, NY 10017. Revised: 02/2012
Last reviewed on RxList: 3/15/2012
This monograph has been modified to include the generic and brand name in many instances.
Additional Xalkori Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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