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U.S. Department of Health and Human Services

Safety

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Vectibix (Panitumumab) Injection for Intravenous Infusion

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) – August 2012

Summary View

 

WARNINGS AND PRECAUTIONS

Dermatologic Toxicity
  • Monitor patients who develop dermatologic toxicities while receiving Vectibix for the development of inflammatory or infectious sequelae…
 
Increased Mortality or Toxicity with Vectibix in Combination with Chemotherapy 
  • Vectibix is not indicated for use in combination with chemotherapy…       
 
Pulmonary Fibrosis/Interstitial Lung Disease (ILD)
  • Pulmonary fibrosis occurred in less than 1% (2/1467) of patients enrolled in clinical studies of Vectibix. Patients with a history or evidence of interstitial pneumonitis, pulmonary fibrosis, were excluded from most clinical trials…
 

ADVERSE REACTIONS

Immunogenicity
  • As monotherapy: The incidence of binding antibodies (excluding pre-existing and transient positive patients) was 0.4% (3/717), as detected by the acid dissociation ELISA, and 3.8% (27/717) as detected by the Biacore assay… 
  • In combination with irinotecan- or oxaliplatin-based chemotherapy: The incidence of binding antibodies (excluding pre-existing positive patients) was 1% (11/1124) as detected by the acid dissociation ELISA and 0.8% (9/1123) as detected by the Biacore assay…