Label Changes for:

Vectibix (panitumumab) Injection for intravenous infusion

August 2014

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)

 

August 2014

WARNINGS AND PRECAUTIONS

Dermatologic and Soft Tissue Toxicity
  • …It could not be determined whether these mucocutaneous adverse reactions were directly related to EGFR inhibition or to idiosyncratic immune-related effects (eg, Stevens Johnson syndrome or toxic epidermal necrolysis)…

ADVERSE REACTIONS

Postmarketing Experience

Skin and subcutaneous tissue disorders:

  • … life threatening and fatal bullous mucocutaneous disease

 

August 2012

WARNINGS AND PRECAUTIONS

Dermatologic Toxicity
  • Monitor patients who develop dermatologic toxicities while receiving Vectibix for the development of inflammatory or infectious sequelae…
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