XALKORI® Highlights

(crizotinib)

HIGHLIGHTS OF PRESCRIBING INFORMATION

These 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
XALKORI (crizotinib) oral pellets
Initial U.S. Approval: 2011

RECENT MAJOR CHANGES

Dosage and Administration (2)

9/2023

INDICATIONS AND USAGE

XALKORI is a kinase inhibitor indicated for the treatment of

•
adult 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. (1.1, 2.1)
•
pediatric patients 1 year of age and older and young adults with relapsed or refractory, systemic anaplastic large cell lymphoma (ALCL) that is ALK-positive. (1.2, 2.3)
o
Limitations of Use: The safety and efficacy of XALKORI have not been established in older adults with relapsed or refractory, systemic ALK-positive ALCL.
•
adult and pediatric patients 1 year of age and older with unresectable, recurrent, or refractory inflammatory myofibroblastic tumor (IMT) that is ALK-positive. (1.3, 2.3)

DOSAGE AND ADMINISTRATION

•
Metastatic NSCLC: The recommended dosage is 250 mg orally twice daily. (2.3)
•
Systemic ALCL: The recommended dosage is 280 mg/m2 orally twice daily based on body surface area. (2.3)
•
Unresectable IMT:
o
Adult: The recommended dosage is 250 mg orally twice daily. (2.3)
o
Pediatric: The recommended dosage is 280 mg/m2 orally twice daily based on body surface area. (2.3)
•
See full prescribing information for dosage adjustments by indication for patients with moderate or severe hepatic impairment or severe renal impairment. (2.7, 2.8)

DOSAGE FORMS AND STRENGTHS

Capsules: 200 mg, 250 mg (3)

Oral pellets: 20 mg, 50 mg, 150 mg (3)

CONTRAINDICATIONS

None. (4)

WARNINGS AND PRECAUTIONS

•
Hepatotoxicity: Fatal hepatotoxicity has occurred. Monitor with periodic liver testing. Temporarily suspend, dose reduce, or permanently discontinue XALKORI. (2.2, 2.6, 5.1)
•
Interstitial Lung Disease (ILD)/Pneumonitis: Permanently discontinue in patients with ILD/pneumonitis. (2.6, 5.2)
•
QT Interval Prolongation: 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. (2.6, 5.3)
•
Bradycardia: XALKORI can cause bradycardia. Monitor heart rate and blood pressure regularly. Temporarily suspend, dose reduce, or permanently discontinue XALKORI. (2.6, 5.4)
•
Severe Visual Loss: XALKORI can cause visual changes including severe visual loss. Monitor and evaluate for ocular toxicity throughout treatment. Discontinue XALKORI in patients with severe visual loss. (2.2, 2.6, 5.5)
•
Gastrointestinal Toxicity in Pediatric and Young Adult Patients with ALCL or Pediatric Patients with IMT: XALKORI can cause severe nausea, vomiting, diarrhea, and stomatitis. Provide standard antiemetic and antidiarrheal agents. Temporarily suspend, dose reduce, or permanently discontinue XALKORI. (2.6, 5.6)
•
Embryo-Fetal Toxicity: Can cause fetal harm. Advise females of reproductive potential of the potential risk to a fetus and use of effective contraception. (5.7, 8.1, 8.3)

ADVERSE REACTIONS

The most common adverse reactions (≥25%) in adult patients with NSCLC are vision disorders, nausea, diarrhea, vomiting, edema, constipation, elevated transaminases, fatigue, decreased appetite, upper respiratory infection, dizziness, and neuropathy. (6.1)

The most common adverse reactions (≥35%) in patients with ALCL are diarrhea, vomiting, nausea, vision disorder, headache, musculoskeletal pain, stomatitis, fatigue, decreased appetite, pyrexia, abdominal pain, cough, and pruritus. Grade 3–4 laboratory abnormalities (≥15%) are neutropenia, lymphopenia, and thrombocytopenia. (6.1)

The most common adverse reactions (≥35%) in adult patients with IMT are vision disorders, nausea, and edema. (6.1)

The most common adverse reactions (≥35%) in pediatric patients with IMT are vomiting, nausea, diarrhea, abdominal pain, rash, vision disorder, upper respiratory tract infection, cough, pyrexia, musculoskeletal pain, fatigue, edema, constipation, and headache. (6.1)

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 concomitant use. (2.9, 7.1)
•
Strong CYP3A Inducers: Avoid concomitant use. (7.1)
•
CYP3A Substrates: Avoid concomitant use with CYP3A substrates, where minimal concentration changes may lead to serious adverse reactions. (7.2)

USE IN SPECIFIC POPULATIONS

Lactation: Advise not to breastfeed. (8.2)

See 17 for PATIENT COUNSELING INFORMATION and Medication Guide.

Revised: 9/2023

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Highlights

HIGHLIGHTS OF PRESCRIBING INFORMATION

These 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
XALKORI (crizotinib) oral pellets
Initial U.S. Approval: 2011

RECENT MAJOR CHANGES

Dosage and Administration (2)

9/2023

INDICATIONS AND USAGE

XALKORI is a kinase inhibitor indicated for the treatment of

•
adult 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. (1.1, 2.1)
•
pediatric patients 1 year of age and older and young adults with relapsed or refractory, systemic anaplastic large cell lymphoma (ALCL) that is ALK-positive. (1.2, 2.3)
o
Limitations of Use: The safety and efficacy of XALKORI have not been established in older adults with relapsed or refractory, systemic ALK-positive ALCL.
•
adult and pediatric patients 1 year of age and older with unresectable, recurrent, or refractory inflammatory myofibroblastic tumor (IMT) that is ALK-positive. (1.3, 2.3)

DOSAGE AND ADMINISTRATION

•
Metastatic NSCLC: The recommended dosage is 250 mg orally twice daily. (2.3)
•
Systemic ALCL: The recommended dosage is 280 mg/m2 orally twice daily based on body surface area. (2.3)
•
Unresectable IMT:
o
Adult: The recommended dosage is 250 mg orally twice daily. (2.3)
o
Pediatric: The recommended dosage is 280 mg/m2 orally twice daily based on body surface area. (2.3)
•
See full prescribing information for dosage adjustments by indication for patients with moderate or severe hepatic impairment or severe renal impairment. (2.7, 2.8)

DOSAGE FORMS AND STRENGTHS

Capsules: 200 mg, 250 mg (3)

Oral pellets: 20 mg, 50 mg, 150 mg (3)

CONTRAINDICATIONS

None. (4)

WARNINGS AND PRECAUTIONS

•
Hepatotoxicity: Fatal hepatotoxicity has occurred. Monitor with periodic liver testing. Temporarily suspend, dose reduce, or permanently discontinue XALKORI. (2.2, 2.6, 5.1)
•
Interstitial Lung Disease (ILD)/Pneumonitis: Permanently discontinue in patients with ILD/pneumonitis. (2.6, 5.2)
•
QT Interval Prolongation: 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. (2.6, 5.3)
•
Bradycardia: XALKORI can cause bradycardia. Monitor heart rate and blood pressure regularly. Temporarily suspend, dose reduce, or permanently discontinue XALKORI. (2.6, 5.4)
•
Severe Visual Loss: XALKORI can cause visual changes including severe visual loss. Monitor and evaluate for ocular toxicity throughout treatment. Discontinue XALKORI in patients with severe visual loss. (2.2, 2.6, 5.5)
•
Gastrointestinal Toxicity in Pediatric and Young Adult Patients with ALCL or Pediatric Patients with IMT: XALKORI can cause severe nausea, vomiting, diarrhea, and stomatitis. Provide standard antiemetic and antidiarrheal agents. Temporarily suspend, dose reduce, or permanently discontinue XALKORI. (2.6, 5.6)
•
Embryo-Fetal Toxicity: Can cause fetal harm. Advise females of reproductive potential of the potential risk to a fetus and use of effective contraception. (5.7, 8.1, 8.3)

ADVERSE REACTIONS

The most common adverse reactions (≥25%) in adult patients with NSCLC are vision disorders, nausea, diarrhea, vomiting, edema, constipation, elevated transaminases, fatigue, decreased appetite, upper respiratory infection, dizziness, and neuropathy. (6.1)

The most common adverse reactions (≥35%) in patients with ALCL are diarrhea, vomiting, nausea, vision disorder, headache, musculoskeletal pain, stomatitis, fatigue, decreased appetite, pyrexia, abdominal pain, cough, and pruritus. Grade 3–4 laboratory abnormalities (≥15%) are neutropenia, lymphopenia, and thrombocytopenia. (6.1)

The most common adverse reactions (≥35%) in adult patients with IMT are vision disorders, nausea, and edema. (6.1)

The most common adverse reactions (≥35%) in pediatric patients with IMT are vomiting, nausea, diarrhea, abdominal pain, rash, vision disorder, upper respiratory tract infection, cough, pyrexia, musculoskeletal pain, fatigue, edema, constipation, and headache. (6.1)

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 concomitant use. (2.9, 7.1)
•
Strong CYP3A Inducers: Avoid concomitant use. (7.1)
•
CYP3A Substrates: Avoid concomitant use with CYP3A substrates, where minimal concentration changes may lead to serious adverse reactions. (7.2)

USE IN SPECIFIC POPULATIONS

Lactation: Advise not to breastfeed. (8.2)

See 17 for PATIENT COUNSELING INFORMATION and Medication Guide.

Revised: 9/2023
Medication Guide

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