Cetuxim 5 mg/ml IV Infusion

Squamous Cell Carcinoma Of The Head And Neck:

Cetuximab in combination with radiation therapy or in combination with platinum-based therapy with 5-FU:

• The recommended initial dose is 400 mg/m² 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.
• The recommended subsequent weekly dose (all other infusions) is 250 mg/m²?infused over 60 minutes (maximum infusion rate 10 mg/min) for the duration of radiation therapy (6?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.

Cetuximab monotherapy:

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

Colorectal Cancer:

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

Recommended Premedication: Premedicate with an H1?antagonist?(eg, 50 mg of?diphenhydramine) intravenously 30?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.