HIGHLIGHTS OF PRESCRIBING INFORMATIONThese highlights do not include all the... |
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ZIRABEV (bevacizumab-bvzr)
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.
ZIRABEV Quick Finder
Highlights
Indications and Usage
1 INDICATIONS AND USAGE
1.1 Metastatic Colorectal Cancer
ZIRABEV, in combination with intravenous fluorouracil-based chemotherapy, is indicated for the first- or...
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Dosage and Administration
2 DOSAGE AND ADMINISTRATION
2.1 Important Administration Information
Withhold for at least 28 days prior to elective surgery. Do not administer ZIRABEV until at least...
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Dosage Forms and Strengths
3 DOSAGE FORMS AND STRENGTHS
Injection: 100 mg/4 mL (25 mg/mL) or 400 mg/16 mL (25 mg/mL) clear to slightly opalescent, colorless to pale brown solution in a single-dose vial
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Warnings and Precautions
5 WARNINGS AND PRECAUTIONS
5.1 Gastrointestinal Perforations and Fistulae
Serious and sometimes fatal gastrointestinal perforation occurred at a higher incidence in...
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Drug Interactions
7 DRUG INTERACTIONS
Effects of ZIRABEV on Other Drugs
No clinically meaningful effect on the pharmacokinetics of irinotecan or its active...
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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
Bevacizumab-bvzr is a vascular endothelial growth factor inhibitor. Bevacizumab-bvzr is a recombinant humanized monoclonal IgG1 antibody that contains human framework regions and murine complementarity-...
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Clinical Pharmacology
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
Bevacizumab products bind VEGF and prevent the interaction of VEGF to its receptors (Flt-1 and KDR) on the surface...
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Nonclinical Toxicology
13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
No studies have been conducted to assess potential of bevacizumab products for...
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Clinical Studies
14 CLINICAL STUDIES
14.1 Metastatic Colorectal Cancer
Study AVF2107g
The safety...
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How Supplied/Storage and Handling
16 HOW SUPPLIED/STORAGE AND HANDLING
ZIRABEV (bevacizumab-bvzr) injection is a clear to slightly opalescent, colorless to pale brown, sterile solution for intravenous infusion supplied in a carton containing one single-dose...
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Medication Guide
17 PATIENT COUNSELING INFORMATION
Gastrointestinal Perforations and Fistulae
Bevacizumab products may increase the risk of developing...
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Other
This product's labeling may have been updated. For the most recent prescribing information, please visit www.pfizer.com.
For medical...
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Report Adverse Event
To report an adverse event related to a Pfizer product 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 either product, adverse events should be reported to your coordinating study site.
If you cannot use the above website to report an adverse event related to a Pfizer product, please call Pfizer Medical Information 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.