<p><strong>Squamous Cell Carcinoma Of The Head And Neck:</strong></p>

<p><strong>Cetuximab in combination with radiation therapy or in combination with platinum-based therapy with 5-FU</strong>:</p>

<ul>
	<li>The recommended initial dose is 400 mg/m2&nbsp;administered one week prior to initiation of a course of radiation therapy or on the day of initiation of platinum-based therapy with 5-FU as a 120-minute intravenous infusion (maximum infusion rate 10 mg/min). Complete Cetuximab administration 1 hour prior to platinum-based therapy with 5-FU.</li>
	<li>The recommended subsequent weekly dose (all other infusions) is 250 mg/m2&nbsp;infused over 60 minutes (maximum infusion rate 10 mg/min) for the duration of radiation therapy (6&ndash;7 weeks) or until disease progression or unacceptable toxicity when administered in combination with platinum-based therapy with 5-FU. Complete Cetuximab administration 1 hour prior to radiation therapy or platinumbased therapy with 5-FU.</li>
</ul>

<p><strong>Cetuximab monotherapy</strong>:</p>

<ul>
	<li>The recommended initial dose is 400 mg/m2&nbsp;administered as a 120-minute intravenous infusion (maximum infusion rate 10 mg/min).</li>
	<li>The recommended subsequent weekly dose (all other infusions) is 250 mg/m2&nbsp;infused over 60 minutes (maximum infusion rate 10 mg/min) until disease progression or unacceptable toxicity.</li>
</ul>

<p><strong>Colorectal Cancer:</strong></p>

<ul>
	<li>Determine EGFR-expression status using FDA-approved tests prior to initiating treatment. Also confirm the absence of a&nbsp;Ras&nbsp;mutation prior to initiation of treatment with Cetuximab.&nbsp;</li>
	<li>The recommended initial dose, either as monotherapy or in combination with irinotecan or FOLFIRI (irinotecan, 5-fluorouracil, leucovorin), is 400 mg/m2&nbsp;administered as a 120-minute intravenous infusion (maximum infusion rate 10 mg/min). Complete Cetuximab administration 1 hour prior to FOLFIRI.</li>
	<li>The recommended subsequent weekly dose, either as monotherapy or in combination with irinotecan or FOLFIRI, is 250 mg/m2&nbsp;infused over 60 minutes (maximum infusion rate 10 mg/min) until disease progression or unacceptable toxicity. Complete Cetuximab administration 1 hour prior to FOLFIRI.</li>
</ul>

<p><strong>Recommended Premedication</strong>: Premedicate with an H1&nbsp;antagonist&nbsp;(eg, 50 mg of&nbsp;diphenhydramine) intravenously 30&ndash;60 minutes prior to the first dose; premedication should be administered for subsequent Cetuximab doses based upon clinical judgment and presence/severity of prior infusion reactions.</p>

<p>&nbsp;</p>

<p><strong>Administration</strong></p>

<p>Do not administer cetuximab 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.<br />
<br />
Parenteral&nbsp;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.&nbsp;Do not s hake or dilute.</p>