Safety

Erbitux (cetuximab)

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

April 2015

Summary View

WARNINGS AND PRECAUTIONS

Increased Tumor Progression, Increased Mortality, or Lack of Benefit in Patients with Ras-Mutant mCRC
  • Erbitux is not indicated for the treatment of patients with colorectal cancer that harbor somatic mutations in exon 2 (codons 12 and 13), exon 3 (codons 59 and 61), and exon 4 (codons 117 and 146) of either K-Ras or N-Ras and hereafter is referred to as “Ras.”Retrospective subset analyses of Ras-mutant and wild-type populations across several randomized clinical trials including Study 4 were conducted to investigate the role of Rasmutations on the clinical effects of anti-EGFR-directed monoclonal antibodies. Use of cetuximab in patients with Ras mutations resulted in no clinical benefit with treatment related toxicity.

 

March 2015

Summary View

WARNINGS AND PRECAUTIONS

Dermatologic Toxicity
  • Life-threatening and fatal bullous mucocutaneous disease with blisters,erosions, and skin sloughing has also been observed in patients treated with Erbitux. 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: Stevens-Johnson syndrome, toxic epidermal necrolysis, life-threatening and fatal bullous mucocutaneous disease

 

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

 

Page Last Updated: 05/13/2015
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