Imclone Llc
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Imclone Llc Drugs
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Erbitux
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.2.2 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 Erbitux. Information on FDA-approved tests for the detection of K-Ras mutations in patients with metastatic colorectal cancer is available at: http://www.fda.gov/medicaldevices/productsandmedicalprocedures/invitrodiagnostics/ucm301431.htm. 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 Erbitux 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 Erbitux administration 1 hour prior to FOLFIRI.2.3 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 Erbitux doses based upon clinical judgment and presence/severity of prior infusion reactions.
2.4 Dose Modifications
Infusion Reactions
Reduce the infusion rate by 50% for NCI CTC Grade 1 or 2 and non-serious NCI CTC Grade 3 infusion reaction.
Immediately and permanently discontinue Erbitux for serious infusion reactions, requiring medical intervention and/or hospitalization. [See Warnings and Precautions (5.1).]
Dermatologic Toxicity
Recommended dose modifications for severe (NCI CTC Grade 3 or 4) acneiform rash are specified in Table 1. [See Warnings and Precautions (5.4).]
Table 1: Erbitux Dose Modification Guidelines for Rash Severe Acneiform Rash Erbitux Outcome Erbitux Dose Modification1st 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
2.5 Preparation for Administration
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.
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.2.2 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 Erbitux. Information on FDA-approved tests for the detection of K-Ras mutations in patients with metastatic colorectal cancer is available at: http://www.fda.gov/medicaldevices/productsandmedicalprocedures/invitrodiagnostics/ucm301431.htm. 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 Erbitux 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 Erbitux administration 1 hour prior to FOLFIRI.2.3 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 Erbitux doses based upon clinical judgment and presence/severity of prior infusion reactions.
2.4 Dose Modifications
Infusion Reactions
Reduce the infusion rate by 50% for NCI CTC Grade 1 or 2 and non-serious NCI CTC Grade 3 infusion reaction.
Immediately and permanently discontinue Erbitux for serious infusion reactions, requiring medical intervention and/or hospitalization. [See Warnings and Precautions (5.1).]
Dermatologic Toxicity
Recommended dose modifications for severe (NCI CTC Grade 3 or 4) acneiform rash are specified in Table 1. [See Warnings and Precautions (5.4).]
Table 1: Erbitux Dose Modification Guidelines for Rash Severe Acneiform Rash Erbitux Outcome Erbitux Dose Modification1st 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
Infusion Reactions
Reduce the infusion rate by 50% for NCI CTC Grade 1 or 2 and non-serious NCI CTC Grade 3 infusion reaction.
Immediately and permanently discontinue Erbitux for serious infusion reactions, requiring medical intervention and/or hospitalization. [See Warnings and Precautions (5.1).]
Dermatologic Toxicity
Recommended dose modifications for severe (NCI CTC Grade 3 or 4) acneiform rash are specified in Table 1. [See Warnings and Precautions (5.4).]
Table 1: Erbitux Dose Modification Guidelines for Rash Severe Acneiform Rash Erbitux Outcome Erbitux Dose Modification1st 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
2.5 Preparation for Administration
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.
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