Erbitux
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Manufacturer Warnings
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FDA Labeling Changes
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Uses
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).]
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)]:
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- in combination with FOLFIRI (irinotecan, 5-fluorouracil, leucovorin) for first-line treatment,
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- in combination with irinotecan in patients who are refractory to irinotecan-based chemotherapy,
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- 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)].
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 CancerErbitux 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)].
History
There is currently no drug history available for this drug.
Other Information
Erbitux® (cetuximab) is a recombinant, human/mouse chimeric monoclonal antibody that binds specifically to the extracellular domain of the human epidermal growth factor receptor (EGFR). Cetuximab is composed of the Fv regions of a murine anti-EGFR antibody with human IgG1 heavy and kappa light chain constant regions and has an approximate molecular weight of 152 kDa. Cetuximab is produced in mammalian (murine myeloma) cell culture.
Erbitux is a sterile, clear, colorless liquid of pH 7.0 to 7.4, which may contain a small amount of easily visible, white, amorphous cetuximab particulates. Erbitux is supplied at a concentration of 2 mg/mL in either 100 mg (50 mL) or 200 mg (100 mL), single-use vials. Cetuximab is formulated in a solution with no preservatives, which contains 8.48 mg/mL sodium chloride, 1.88 mg/mL sodium phosphate dibasic heptahydrate, 0.41 mg/mL sodium phosphate monobasic monohydrate, and Water for Injection, USP.
Sources
Erbitux Manufacturers
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Imclone Llc
![Erbitux (Cetuximab) Solution [Imclone Llc]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Erbitux | Imclone Llc
2.1 Squamous Cell Carcinoma of the Head and NeckErbitux 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 PremedicationPremedicate 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 ReactionsReduce 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 ToxicityRecommended 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 AdministrationDo 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 NeckErbitux 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 PremedicationPremedicate 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 ReactionsReduce 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 ToxicityRecommended 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 ReactionsReduce 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 ToxicityRecommended 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 AdministrationDo 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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