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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




  • Progressive Multifocal Leukoencephalopathy (PML)


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


  • 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...


  • Conversion of the Patient Package Insert to a Medication Guide


  • 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...


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


  • 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...