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Safety

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Raptiva (efalizumab) for Injection, Subcutaneous October 2008

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) -- October 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

BOXED WARNING (new)

  • WARNING: RISK OF SERIOUS INFECTIONS

WARNINGS

  • Serious Infections
  • Neurologic Events (new subsection)

PRECAUTIONS

  • Immunizations
  • Information for Patients
  • Carcinogenesis, Mutagenesis, Impairment of Fertility
  • Pediatric Use

ADVERSE REACTIONS

  • Initial Paragraph
  • Infections
  • Postmarketing Experience
    • Infections
      • serious bacterial, fungal, viral and other opportunistic infections, including JC virus resulting in PML...
    • Malignancies
      • lymphoma
    • Neurologic
      • Guillain-BarrĂ© Syndrome, chronic inflammatory demyelinating polyneuropathy, transverse myelitis, and facial palsy...

PATIENT PACKAGE INSERT

  • Initial Paragraph
  • What is the most important information I should know about Raptiva?
  • What should I avoid while using Raptiva?
  • What are the possible side effects of Raptiva?

BOXED WARNING

WARNING: RISK OF SERIOUS INFECTIONS

  • Infections, including serious infections leading to hospitalizations or death, have been observed in patients treated with Raptiva (see WARNINGS and ADVERSE REACTIONS). These infections have included bacterial sepsis, viral meningitis, invasive fungal disease and other opportunistic infections. Patients should be educated about the symptoms of infection and be closely monitored for signs and symptoms of infection during and after treatment with Raptiva. If a patient develops a serious infection, Raptiva should be discontinued and appropriate therapy instituted.
  • Progressive Multifocal Leukoencephalopathy (PML) resulting from JC virus infection has occurred during therapy with Raptiva (see WARNINGS).

WARNINGS

Serious Infections:

Progressive Multifocal Leukoencephalopathy (PML) has been reported in a post-marketing study. Physicians treating patients with Raptiva should consider PML in any patient with new-onset neurologic manifestations. Consultation with a neurologist, brain MRI, and lumbar puncture should be considered as clinically indicated. Patients being treated with Raptiva should be instructed to report any new neurological signs or symptoms to their physician. Raptiva should be discontinued in patients who develop PML.

In postmarketing experience, serious bacterial, viral, fungal, and opportunistic infections have occurred, including pneumonia, sepsis, meningitis, and encephalitis. Some of these infections have been fatal. Postmarketing reports include cytomegaloviral infections; blastomyces, cryptococcal and tuberculous pneumonia; serious herpes infections...

Neurologic Events:

One case of transverse myelitis was observed during the clinical development program (2762 Raptiva-treated patients); neurologic events, including cases of Guillain-Barré Syndrome, chronic inflammatory demyelinating polyneuropathy, facial palsy, and transverse myelitis have been observed in patients receiving Raptiva in the postmarketing setting (see ADVERSE REACTIONS, Postmarketing Experience). Patients being treated with Raptiva should be instructed to report any new neurological signs or symptoms to their physician. Prescribers should exercise caution in considering the use of Raptiva in patients with significant existing or new onset nervous system adverse events. Raptiva should be discontinued in patients who develop PML.
    
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