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U.S. Department of Health and Human Services

Safety

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Herceptin (trastuzumab) Intravenous Infusion May 2008


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

WARNINGS AND PRECAUTIONS

  • Cardiomyopathy
    • Cardiac Monitoring
    • Table 1
    • Table 2

ADVERSE REACTIONS

  • Clinical Trials Experience
    • Adjuvant Breast Cancer Studies
      • Safety data from Study 4 ...
    • Metastatic Breast Cancer Studies
    • Cardiomyopathy
      • Table 5
        • Figure 3

WARNINGS AND PRECAUTIONS

Cardiac Monitoring

...In Study 4, a total of 2.9% (31/1056) patients in the TCH arm (1.5% during the chemotherapy phase and 1.4% during the monotherapy phase) and 5.7% (61/1068) patients in the AC-TH arm (1.5% during the chemotherapy phase and 4.2% during the monotherapy phase) discontinued Herceptin due to cardiac toxicity...

See highlighted prescribing information for additional new text.

 

Label approved 05/22/2008 is not available on Drugs@FDA

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