Label Changes for:

Raptiva (efalizumab)

March 2009

Changes have been made to the BOXED WARNING, CONTRAINDICATIONS, 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 2009

 

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

 

Sections Modified

Summary of Changes to Contraindications and Warnings

BOXED WARNING

CONTRAINDICATIONS

WARNINGS

  • Progressive Multifocal Leukoencephalopathy (PML)

PRECAUTIONS

  • Information for Patients
    • Healthcare providers should counsel patients about the risks and benefits of Raptiva...

ADVERSE REACTIONS

  • The most serious adverse reactions observed during treatment with Raptiva are serious infections, including PML...
  • In postmarketing experience, serious bacterial, viral, fungal, and opportunistic infections
    have occurred, including JC virus infection resulting in PML...

MEDICATION GUIDE

  • Conversion of the Patient Package Insert to a Medication Guide

BOXED WARNING

  • Warning: Risk of Progressive Mutifocal Leukoencephalopathy (PML)
    • Raptiva increases the risk for PML, a rapidly progressive viral infection of the central nervous system that...
    • Patients on Raptiva should be monitored frequently...
    • Raptiva dosing should be withheld immediately at the first sign or symptom suggestive of PML...

CONTRAINDICATIONS

  • should not be administered to patients who have been diagnosed with PML

WARNINGS

  • Progressive Multifocal Leukoencephalopathy (PML)
    • PML is a rapidly progressive infection of the central nervous system caused by the JC virus that leads to death or severe disability.
    • Raptiva increases the risk for PML and this risk may markedly increase with longer duration ..... Post-marketing cases...
    • The effect of intermittent use of Raptiva...
    • Healthcare providers treating patients with Raptiva should consider...
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