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U.S. Department of Health and Human Services

Safety

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Neulasta (pegfilgrastim) Apr 2008


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

WARNINGS

  • Allergic Reactions

ADVERSE REACTIONS

  • Postmarketing Experience (new subsection)

PATIENT PACKAGE INSERT

  • What is Neulasta used for?
  • What are possible serious side effects of Neulasta?
    • Serious Allergic Reactions
      • Hives

WARNINGS

Allergic Reactions

Allergic reactions to Neulasta, manifesting as anaphylaxis, angioedema, or urticaria have been reported in postmarketing experience...

 

The April 2008 Label not available at this site.