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

Find XALKORI® medical information:

Find XALKORI® medical information:

Our scientific content is evidence-based, scientifically balanced and non-promotional. It undergoes rigorous internal medical review and is updated regularly to reflect new information.

XALKORI® Quick Finder

Prescribing Information
Download Prescribing Information

Health Professional Information

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

Health Professional Information

{{section_name_patient}}

{{section_body_html_patient}}

Resources

Didn’t find what you were looking for? Contact us.

MI Digital Assistant

Chat online with Pfizer Medical Information regarding your inquiry on a Pfizer medicine.

Call 800-438-1985*

*Speak with a Pfizer Medical Information Professional regarding your medical inquiry. Available 9AM-5PM ET Monday to Friday; excluding holidays.

Medical Inquiry

Submit a medical question for Pfizer prescription products.

Report Adverse Event

Pfizer Safety

To report an adverse event related to the Pfizer-BioNTech COVID-19 Vaccine, and you are not part of a clinical trial* for this product, click the link below to submit your information:

Pfizer Safety Reporting Site

*If you are involved in a clinical trial for this product, adverse events should be reported to your coordinating study site.

If you cannot use the above website, or would like to report an adverse event related to a different Pfizer product, please call Pfizer Safety at (800) 438-1985.

FDA Medwatch

You may also contact the U.S. Food and Drug Administration (FDA) directly to report adverse events or product quality concerns either online at www.fda.gov/medwatch or call (800) 822-7967.