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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


  • Cardiomyopathy
    • Cardiac Monitoring
    • Table 1
    • Table 2


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


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