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U.S. Department of Health and Human Services

Safety

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Herceptin (trastuzumab) Intravenous Infusion


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

BOXED WARNING

  • Cardiomyopathy
  • Infusion Reactions; Pulmonary Toxicity

WARNINGS AND PRECAUTIONS

  • Cardiomyopathy
  • Table 1
  • Table 2
  • Infusion Reactions
    • In postmarketing reports, serious and fatal infusion reactions have been reported...
  • HER2 Testing
  • Embryo-Fetal Toxicity (Pregnancy Category D)

ADVERSE REACTIONS

  • Initial Section
    • Adverse reactions requiring interruption or discontinuation of Herceptin treatment include: pulmonary toxicity (added)

PATIENT COUNSELING INFORMATION

BOXED WARNING

Cardiomyopathy

Herceptin can result in sub-clinical and clinical cardiac failure manifesting as CHF and decreased LVEF...

Infusions Reactions; Pulmonary Toxicity

...Fatal infusion reactions have been reported.

...Discontinue Herceptin for infusion reactions manifesting as anaphylaxis, angioedema, interstitial pneumonitis, or acute respiratory distress syndrome. [see Warnings and Precautions (5.2, 5.4)]

WARNINGS AND PRECAUTIONS

See highlighted text for labeling revisions.