Avastin (bevacizumab) For Intravenous Use November 2008
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.|
Summary of Changes to Contraindications and Warnings
...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%)...
...In a published case series, kidney biopsy of six patients with proteinuria showed fIndings consistent with thrombotic microangiopathy...