Label Changes for:

Zevalin (ibritumomab tiuxetan) Injection for Intravenous Use

March 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) -- March 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.


Summary View

 

Sections Modified Summary of Changes to Contraindications and Warnings

WARNINGS AND PRECAUTIONS

  • Serious Infusion Reactions

ADVERSE REACTIONS

  • Severe or life-threatening adverse reactions occuring...
    • Infusion Reaction (1%)...
  • Immunogenicity

USE IN SPECIFIC POPULATIONS

  • Pregnancy

PATIENT COUNSELING INFORMATION

WARNINGS AND PRECAUTIONS

Serious Infusion Reactions

Rituximab, alone or as a component of the Zevalin therapeutic regimen, can cause severe including fatal infusiƶn reactions...

...Temporarily slow or interrupt the rituximab infusion for less severe infusion reactions. Immediately stop rituximab, In-111 Zevalin, or Y-90 Zevalin administration for severe infusion reactions...

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