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ZIRABEV (bevacizumab-bvzr)

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ZIRABEV Quick Finder

HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the...
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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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2 DOSAGE AND ADMINISTRATION

2.1 Important Administration Information

Withhold for at least 28 days prior to...

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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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4 CONTRAINDICATIONS

None.

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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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6 ADVERSE REACTIONS

The following clinically significant adverse reactions are described elsewhere in the labeling:

  • Gastrointestinal Perforations and Fistulae [see

    6.1...

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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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8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

Risk Summary

Based on findings from...

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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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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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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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14 CLINICAL STUDIES

14.1 Metastatic Colorectal Cancer

Study AVF2107g

The safety...

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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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17 PATIENT COUNSELING INFORMATION

Gastrointestinal Perforations and Fistulae

Bevacizumab products may increase the risk of developing...

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This product's labeling may have been updated. For the most recent prescribing information, please visit www.ZIRABEV.com.

Manufactured by
Pfizer Inc.
NY, NY...

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