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U.S. Department of Health and Human Services

Safety

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Tysabri (natalizumab) Injection For Intravenous Use


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

CONTRAINDICATIONS

WARNINGS AND PRECAUTIONS

  • Progressive Multifocal Leukoencephalopathy (PML)
  • Distribution Program for Tysabri
  • Hypersensitivity/Antibody Formation
  • Immunosuppression/Infections
  • Hepatotoxicity

ADVERSE REACTIONS

  • Clinical Trials Experience
    • Initial Section
    • Multiple Sclerosis Clinical Studies
    • Crohn's Disease Clinical Studies
      • Table 2
      • Table 3
    • Infections
    • Infusion-related Reactions
    • Immunogenicity

DRUG INTERACTIONS

USE IN SPECIFIC POPULATIONS

  • Pregnancy
  • Geriatric Use

PATIENT COUNSELING INFORMATION

  • General Counseling Information
  • Progressive Multifocal Leukoencephalopathy
  • Immunosuppression/Infections
  • Hepatotoxicity

MEDICATION GUIDE

CONTRAINDICATIONS

Tysabri should not be administered to a patient who has had a hypersensitivity reaction to Tysabri. Observed reactions range from urticara to anaphylaxis [see Warnings and Precautions (5.3)].

WARNINGS AND PRECAUTIONS

See highlighted text for labeling revisions.