ERBITUX- cetuximab solution
ImClone LLC
WARNING: SERIOUS INFUSION REACTIONS and CARDIOPULMONARY ARREST
Infusion Reactions: Serious infusion reactions occurred with the administration of Erbitux in approximately 3% of patients in clinical trials, with fatal outcome reported in less than 1 in 1000. [See Warnings and Precautions (5.1), Adverse Reactions (6).] Immediately interrupt and permanently discontinue Erbitux infusion for serious infusion reactions. [See Dosage and Administration (2.4), Warnings and Precautions (5.1).]
Cardiopulmonary Arrest: Cardiopulmonary arrest and/or sudden death occurred in 2% of patients with squamous cell carcinoma of the head and neck treated with Erbitux and radiation therapy in Study 1 and in 3% of patients with squamous cell carcinoma of the head and neck treated with European Union (EU)-approved cetuximab in combination with platinum-based therapy with 5-fluorouracil (5-FU) in Study 2. Closely monitor serum electrolytes, including serum magnesium, potassium, and calcium, during and after Erbitux administration. [See Warnings and Precautions (5.2, 5.6), Clinical Studies (14.1).]
1 INDICATIONS AND USAGE
1.1 Squamous Cell Carcinoma of the Head and Neck (SCCHN)
Erbitux� is indicated in combination with radiation therapy for the initial treatment of locally or regionally advanced squamous cell carcinoma of the head and neck. [See Clinical Studies (14.1).]
Erbitux is indicated in combination with platinum-based therapy with 5-FU for the first-line treatment of patients with recurrent locoregional disease or metastatic squamous cell carcinoma of the head and neck. [See Clinical Studies (14.1).]
Erbitux, as a single agent, is indicated for the treatment of patients with recurrent or metastatic squamous cell carcinoma of the head and neck for whom prior platinum-based therapy has failed. [See Clinical Studies (14.1).]
1.2 K-Ras Wild-type, EGFR-expressing Colorectal Cancer
Erbitux is indicated for the treatment of K-Ras wild-type, epidermal growth factor receptor (EGFR)-expressing, metastatic colorectal cancer (mCRC) as determined by FDA-approved tests for this use [see Dosage and Administration (2.2), Warnings and Precautions (5.7), Clinical Studies (14.2)]:
in combination with FOLFIRI (irinotecan, 5-fluorouracil, leucovorin) for first-line treatment,
in combination with irinotecan in patients who are refractory to irinotecan-based chemotherapy,
as a single agent in patients who have failed oxaliplatin- and irinotecan-based chemotherapy or who are intolerant to irinotecan. [See Warnings and Precautions (5.7), Clinical Pharmacology (12.1), Clinical Studies (14.2).]
Limitation of Use: Erbitux is not indicated for treatment of Ras- mutant colorectal cancer or when the results of the Ras mutation tests are unknown [see Warnings and Precautions (5.7), Clinical Studies (14.2)].
2 DOSAGE AND ADMINISTRATION
2.1 Squamous Cell Carcinoma of the Head and Neck
Erbitux 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 Erbitux 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 Erbitux administration 1 hour prior to radiation therapy or platinum-based therapy with 5-FU.
Erbitux 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.
