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U.S. Department of Health and Human Services

Safety

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Avastin (bevacizumab) Solution for intravenous infusion

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)  

 

October 2012

Summary View

 

ADVERSE REACTIONS

Immunogenicity
  • As with all therapeutic proteins, there is a potential for an immune response to Avastin. In clinical trials of adjuvant colon carcinoma, 14 of 2233 evaluable patients (0.63%) tested positive for treatment-emergent anti-bevacizumab antibodies detected by an electrochemiluminescent (ECL) based assay. Among these 14 patients, three tested positive for neutralizing antibodies against  bevacizumab using an enzyme-linked immunosorbent assay (ELISA). The clinical significance of these anti-product antibody responses to bevacizumab is unknown.

 

May 2012

Summary View

 

6 ADVERSE REACTIONS

6.1 Clinical Trial Experience
  • congestive heart failure
6.3 Postmarketing Experience
  • hepatobiliary disorders, gallbladder perforation

 

December 2011 

Summary View

 

ADVERSE REACTIONS

Postmarketing Experience
  • include additional information regarding ocular and systemic adverse events following unapproved intravitreal use for treatment of various ocular disorders.

 

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