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U.S. Department of Health and Human Services

Safety

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Erbitux (cetuximab)

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

 

March 2013

Summary View

WARNINGS AND PRECAUTIONS

Use of Erbitux in Combination With Radiation and Cisplatin
  • In a controlled study, 940 patients with locally advanced SCCHN were randomized 1:1 to receive either Erbitux in combination with radiation therapy and cisplatin or radiation therapy and cisplatin alone. The addition of Erbitux resulted in an increase in the incidence of Grade 3–4 mucositis, radiation recall syndrome, acneiform rash, cardiac events, and electrolyte disturbances compared to radiation and cisplatin alone. Adverse reactions with fatal outcome were reported in 20 patients (4.4%) in the Erbitux combination arm and 14 patients (3.0%) in the control arm. Nine patients in the Erbitux arm (2.0%) experienced myocardial ischemia compared to 4 patients (0.9%) in the control arm. The main efficacy outcome of the study was progression-free survival (PFS). The addition of Erbitux to radiation and cisplatin did not improve PFS.

ADVERSE REACTIONS

Postmarketing Experience
  • mucosal inflammation 

 

 

January 2012

Summary View

5 WARNINGS AND PRECAUTIONS

5.4 Dermatologic Toxicity
  • ulcerative keratitis with decreased visual acuity…..added