ings and Precautions (5.1) .]
Recommended dose modifications for severe (NCI CTC Grade 3 or 4) acneform rash are specified in Table 1. [See Warnings and Precautions (5.4) .]
Table 1: Erbitux Dose Modification Guidelines for Rash
Severe Acneform
Rash |
Erbitux |
Outcome |
ErbituxDose
Modification |
|
1st occurrence |
Delay infusion 1 to 2 weeks |
Improvement |
Continue at 250 mg/m2 |
|
|
|
No Improvement |
Discontinue Erbitux |
|
2nd occurrence |
Delay infusion 1 to 2 weeks |
Improvement |
Reduce dose to 200 mg/m2 |
|
|
|
No Improvement |
Discontinue Erbitux |
|
3rd occurrence |
Delay infusion 1 to 2 weeks |
Improvement |
Reduce dose to 150 mg/m2 |
|
|
|
No Improvement |
Discontinue Erbitux |
|
4th occurrence |
Discontinue Erbitux |
|
|
Do not administer Erbitux as an intravenous push or bolus.
Administer via infusion pump or syringe pump. Do not exceed an infusion rate of 10 mg/min.
Administer through a low protein binding 0.22-micrometer in-line filter.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
The solution should be clear and colorless and may contain a small amount of easily visible, white, amorphous, cetuximab particulates. Do not shake or dilute.
100 mg/50 mL, single-use vial
200 mg/100 mL, single-use vial
None.
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.
Approximately 90% of severe infusion reactions occurred with the first infusion despite premedication with antihistamines.
Monitor patients for 1 hour following Erbitux infusions in a setting with resuscitation equipment and other agents necessary to treat anaphylaxis (eg, epinephrine, corticosteroids, intravenous antihistamines, bronchodilators, and oxygen). Monitor longer to confirm resolution of the event in patients requiring treatment for infusion reactions.
Immediately and permanently discontinue Erbitux in patients with serious infusion reactions. [See Boxed Warning and Dosage and Administration (2.4) .]
Cardiopulmonary arrest and/or sudden death occurred in 4 (2%) of 208 patients treated with radiation therapy and Erbitux as compared to none of 212 patients treated with radiation therapy alone in a randomized, controlled trial in patients with SCCHN. Three patients with prior history of coronary artery disease died at home, with myocardial infarction as the presumed cause of death. One of these patients had arrhythmia and one had congestive heart failure. Death occurred 27, 32, and 43 d
