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XALKORI®(crizotinib)
If you provide additional keywords, you may be able to browse through our database of Scientific Response Documents.
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
Highlights
Indications and Usage
1 INDICATIONS AND USAGE
1.1 ALK- or ROS1-Positive Metastatic Non-Small Cell Lung Cancer
XALKORI is indicated for the treatment of patients with metastatic non-small...
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Dosage and Administration
2 DOSAGE AND ADMINISTRATION
2.1 Patient Selection
Select patients for the treatment of metastatic NSCLC with XALKORI based on the presence of ALK or ROS1 positivity...
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Dosage Forms and Strengths
3 DOSAGE FORMS AND STRENGTHS
Capsules:
- 250 mg: hard gelatin capsule, size 0, pink opaque cap and body, with "Pfizer" on the cap and "CRZ 250" on the body.
- 200 mg: hard gelatin capsule, size 1...
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Warnings and Precautions
5 WARNINGS AND PRECAUTIONS
5.1 Hepatotoxicity
Drug-induced hepatotoxicity with fatal outcome occurred in 0.1% of the 1719 patients treated with XALKORI for NSCLC...
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Adverse Reactions
6 ADVERSE REACTIONS
The following clinically significant adverse reactions are described elsewhere in the labeling:
- Hepatotoxicity [see Warnings and Precautions (...
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Drug Interactions
7 DRUG INTERACTIONS
7.1 Effect of Other Drugs on XALKORI
Strong or Moderate CYP3A Inhibitors...
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Use in Specific Populations
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
Risk Summary
Based on findings from...
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Description
11 DESCRIPTION
Crizotinib is a kinase inhibitor. The molecular formula for crizotinib is C21H22Cl2FN5O and the molecular...
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Clinical Pharmacology
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
Crizotinib is an inhibitor of receptor tyrosine kinases including ALK, Hepatocyte Growth Factor Receptor (HGFR, c-...
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Nonclinical Toxicology
13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
Carcinogenicity studies with crizotinib have not been conducted.
Crizotinib...
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Clinical Studies
14 CLINICAL STUDIES
14.1 ALK- or ROS1-Positive Metastatic Non-Small Cell Lung Cancer
...
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How Supplied/Storage and Handling
16 HOW SUPPLIED/STORAGE AND HANDLING
- 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:...
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Medication Guide
| This Medication Guide has been approved by the U.S. Food and Drug Administration. | Revised: July 2022 | |||
| ... | ||||
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Resources
Report Adverse Event
To report an adverse event related to Pfizer-BioNTech COVID-19 Vaccine (also known as COMIRNATY®, COVID-19 mRNA, Vaccine BNT162b2 or BNT162) or Pfizer COVID-19 Treatment (also known as PAXLOVID™ (nirmatrelvir tablets; ritonavir tablets)), and you are not part of a clinical trial* for this product, click the link below to submit your information:
*If you are involved in a clinical trial for either 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.
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/medwatchor by calling
(800)-332-1088.
(800)-332-1088.