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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)
Clinical Trial Experience
- *revised to provide the incidence information regarding post-treatment vascular events.*
- 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.
6 ADVERSE REACTIONS
6.1 Clinical Trial Experience
- congestive heart failure
6.3 Postmarketing Experience
- hepatobiliary disorders, gallbladder perforation
- include additional information regarding ocular and systemic adverse events following unapproved intravitreal use for treatment of various ocular disorders.