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.


Summary View

 

Sections Modified

Summary of Changes to Contraindications and Warnings

WARNINGS

  • Hemorrhage
  • Proteinuria

PRECAUTIONS

  • Drug Interactions
    • A drug interaction study was performed in which irinotecan was administered as part of the FOLFIRI regimen with or without Avastin. The results demonstrated no significant effect of bevacizumab on the
      pharmacokinetics of irinotecan or its active metabolite SN38...

ADVERSE REACTIONS

  • Other Adverse Events
    • Respiratory
      • dysphonia (added)
    • Renal (new subsection)
      • Renal thrombotic microangiopathy (manifested as severe
        proteinuria)

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...

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