hese highlights do not include all the information needed to use XALKORI � safely and effectively. See full prescribing information for XALKORI.
XALKORI � (crizotinib) capsules, for oral use
Initial U.S. Approval: 2011
RECENT MAJOR CHANGES
Indications and Usage (1) 7/2017
Dosage and Administration, Patient Selection (2.1) 7/2017
Dosage and Administration, Recommended Dosing (2.2) 2/2018
INDICATIONS AND USAGE
XALKORI is a kinase inhibitor indicated for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors are anaplastic lymphoma kinase (ALK) or ROS1-positive as detected by an FDA-approved test. (1)
DOSAGE AND ADMINISTRATION
Recommended Dose: 250 mg orally twice daily. (2.2)
Moderate Hepatic Impairment: 200 mg orally twice daily. (2.2)
Severe Hepatic Impairment: 250 mg orally once daily. (2.2)
Severe Renal Impairment: 250 mg orally once daily. (2.2)
DOSAGE FORMS AND STRENGTHS
Capsules: 250 mg and 200 mg. (3)
CONTRAINDICATIONS
None. (4)
WARNINGS AND PRECAUTIONS
Hepatotoxicity: Fatal hepatotoxicity occurred in 0.1% of patients. Monitor with periodic liver testing. Temporarily suspend, dose reduce, or permanently discontinue XALKORI. (5.1)
Interstitial Lung Disease (ILD)/Pneumonitis: Occurred in 2.9% of patients. Permanently discontinue in patients with ILD/pneumonitis. (5.2)
QT Interval Prolongation: Occurred in 2.1% of patients. Monitor electrocardiograms and electrolytes in patients who have a history of or predisposition for QTc prolongation, or who are taking medications that prolong QT. Temporarily suspend, dose reduce, or permanently discontinue XALKORI. (5.3)
Bradycardia: XALKORI can cause bradycardia. Monitor heart rate and blood pressure regularly. Temporarily suspend, dose reduce, or permanently discontinue XALKORI. (5.4)
Severe Visual Loss: Reported in 0.2% of patients. Discontinue XALKORI in patients with severe visual loss. Perform an ophthalmological evaluation. (5.5)
Embryo-Fetal Toxicity: Can cause fetal harm. Advise females of reproductive potential of the potential risk to a fetus and use of effective contraception. (5.6, 8.1, 8.3)
ADVERSE REACTIONS
The most common adverse reactions (≥25%) are vision disorders, nausea, diarrhea, vomiting, edema, constipation, elevated transaminases, fatigue, decreased appetite, upper respiratory infection, dizziness, and neuropathy. (6)
To report SUSPECTED ADVERSE REACTIONS, contact Pfizer Inc. at 1-800-438-1985 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
DRUG INTERACTIONS
Strong CYP3A Inhibitors: Avoid coadministration with XALKORI. (7.1)
Strong CYP3A Inducers: Avoid coadministration with XALKORI. (7.2)
CYP3A Substrates: Avoid coadministration of CYP3A substrates with narrow therapeutic indices with XALKORI. (7.3)
USE IN SPECIFIC POPULATIONS
Lactation: Do not breastfeed while taking XALKORI. (8.2)
See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling.
Revised: 2/2018
