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Label Changes for:

Erbitux (cetuximab) Solution for Intravenous Use

September 2008

Changes have been made to the WARNINGS, PRECAUTIONS and ADVERSE REACTIONS sections of the safety label.

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

  • Infusion Reactions
    • Initial Paragraph
      • shock, loss of consciousness, myocardial infarction (added)
  • Dermatology Toxicity
    • Initial Paragraph
      • conjunctivitis, keratitis, hypertrichosis (added)

ADVERSE REACTIONS

  • Clinical Trials Experience
    • Squamous Cell Carcinoma of the Head and Neck
      • Table 2
        • Metabolic/Nutritional

WARNINGS AND PRECAUTIONS

Infusion Reactions

Serious infusion reactions, requiring medical intervention and immediate, permanent discontinuation of Erbitux included rapid onset of airway obstruction (bronchospasm, stridor, hoarseness), hypotension, shock, loss of consciousness, myocardial infarction, and/or cardiac arrest. Severe (NCI CTC Grades 3 and 4) infusion reactions occurred in 2-5% of 1373 patients in clinical trials, with fatal outcome in 1 patient.

Dermatology Toxicity

Dermatologic toxicities, including acneform rash, skin drying and fissuring, paronychial inflammation, infectious sequelae (for example S. aureus sepsis, abscess formation, cellulitis, blepharitis, conjunctivitis, keratitis, cheilitis), and hypertrichosis occurred in patients receiving Erbitux therapy. Acneform rash occurred in 76-88% of 1373 patients receiving Erbitux in clinical trials. Severe acneform rash occurred in 1-17 % of patients.

Label approved 09/12/2008 is not available on this site

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