Label Changes for:
Avastin (bevacizumab) For Intravenous Use
November 2008
Changes have been made to the WARNINGS, PRECAUTIONS and ADVERSE REACTIONS sections of the safety label.
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) -- November 2008
| The detailed view includes drug products with safety labeling changes to the BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS, or PATIENT PACKAGE INSERT/MEDICATION GUIDE sections. Deletions or editorial revisions made to these sections are not included in this summary. Read about the new physician labeling format. |
| Sections Modified |
Summary of Changes to Contraindications and Warnings |
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WARNINGS
PRECAUTIONS
ADVERSE REACTIONS
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WARNINGS Hemorrhage: ...Interim data from two ongoing clinical studies in patients with non-small cell lung cancer, in which patients with CNS metastases had completed either radiation and/or surgery more than 4 weeks prior to the start of Avastin and were evaluated on study with CNS imaging, documented symptomatic Grade 2 CNS hemorrhage in one of 83 Avastin-treated patients (rate 1.2%, 95% CI 0.06% - 5.93%)... Proteinuria: ...In a published case series, kidney biopsy of six patients with proteinuria showed fIndings consistent with thrombotic microangiopathy... |
