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Erbitux Generic Name & Formulations
Legal Class
Rx
General Description
Cetuximab 100mg, 200mg; per vial; soln for IV infusion; preservative-free.
Pharmacological Class
Epidermal growth factor receptor blocker.
How Supplied
Single-dose vials (50mL, 100mL)—1
Manufacturer
Generic Availability
NO
Erbitux Indications
Indications
K-Ras (wild-type), EGFR-expressing metastatic colorectal cancer (CRC): for use in combination with FOLFIRI (irinotecan, 5-fluorouracil, leucovorin) for first-line treatment, or in combination with irinotecan (if refractory to irinotecan-based chemotherapy), or as a single agent (after failure of both irinotecan- and oxaliplatin-based regimens or if irinotecan-intolerant). In combination with encorafenib, for adults with metastatic CRC with a BRAF V600E mutation, as detected by an FDA-approved test, after prior therapy.
Limitations of Use
Not indicated for Ras mutant colorectal cancer that harbor somatic mutations in exon 2 (codons 12 and 13), exon 3 (codons 59 and 61), and exon 4 (codons 117 and 146) or when Ras mutation test results are unknown.
Erbitux Dosage and Administration
Adult
Confirm EGFR-expressing or BRAF V600E mutation-positive (using FDA-approved tests) CRC prior to initiation. Pretreat with H1 blocker. Give by IV infusion (use filter); max rate: 10mg/min. Single agent or in combination with irinotecan or FOLFIRI: Weekly regimen (initial dose): 400mg/m2 once over 2hrs; (subsequent doses): 250mg/m2 once weekly over 1hr. Biweekly regimen (initial and subsequent doses): 500mg/m2 every 2 weeks over 2hrs. Complete administration 1hr prior to irinotecan or FOLFIRI. In combination with encorafenib (initial dose): 400mg/m2 once over 2hrs; (subsequent doses): 250mg/m2 once weekly over 1hr. All: continue until disease progression or unacceptable toxicity. Dose modifications for toxicity: see full labeling.
Children
Not established.
Erbitux Contraindications
Not Applicable
Erbitux Boxed Warnings
Boxed Warning
Infusion reactions. Cardiopulmonary arrest.
Erbitux Warnings/Precautions
Warnings/Precautions
Monitor for infusion reactions during and for ≥1hr post-infusion; if occurs, immediately interrupt and permanently discontinue based on severity. Increased risk of anaphylactic reactions with history of tick bites, red meat allergy, presence of IgE antibodies against galactose-α-1,3-galactose. Have emergency treatment readily available. Risk of cardiopulmonary arrest and/or sudden death; carefully consider use (w. irradiation or platinum-based therapy with 5-FU) in coronary artery disease, CHF, or arrhythmias. Monitor for pulmonary toxicity; interrupt for acute onset or worsening pulmonary symptoms; permanently discontinue if interstitial lung disease confirmed. Monitor for dermatologic toxicities (eg, acneiform rash, mucocutaneous disease) and infectious sequelae; withhold, reduce dose or permanently discontinue based on severity of reactions. Avoid sun exposure. Monitor electrolytes (eg, magnesium, potassium, calcium) during and for ≥8wks after cetuximab therapy. Embryo-fetal toxicity. Advise females of reproductive potential to use effective contraception during and for 2 months after the last dose. Pregnancy: exclude status prior to initiation. Nursing mothers: not recommended (during and for 2 months after the last dose).
Erbitux Pharmacokinetics
See Literature
Erbitux Interactions
Interactions
Increased mucositis (Grade 3–4), radiation recall syndrome, acneiform rash, cardiac events, and electrolyte disturbances with radiation and cisplatin.
Erbitux Adverse Reactions
Adverse Reactions
Cutaneous reactions (eg, rash, pruritus, nail changes), headache, diarrhea, infection; infusion reactions (may be severe), cardiopulmonary arrest, interstitial lung disease, dermatologic toxicities, electrolyte abnormalities (eg, hypomagnesemia).
Erbitux Clinical Trials
See Literature
Erbitux Note
Notes
Testing considerations: EGFR amplification analysis, K-RAS mutation analysis, BRAF mutation analysis.
Erbitux Patient Counseling
See Literature
Erbitux Generic Name & Formulations
Legal Class
Rx
General Description
Cetuximab 100mg, 200mg; per vial; soln for IV infusion; preservative-free.
Pharmacological Class
Epidermal growth factor receptor blocker.
How Supplied
Single-dose vials (50mL, 100mL)—1
Manufacturer
Generic Availability
NO
Erbitux Indications
Indications
In combination with radiation therapy for the initial treatment of locally or regionally advanced squamous cell carcinoma of the head and neck (SCCHN). In combination with platinum-based therapy with 5-fluorouracil (5-FU) for first-line treatment of recurrent locoregional disease or metastatic SCCHN. As a single agent for recurrent or metastatic SCCHN after failure of prior platinum-based therapy.
Erbitux Dosage and Administration
Adult
Pretreat with H1 blocker. Give by IV infusion (use filter); max rate: 10mg/min. In combination with radiation therapy (initial dose): 400mg/m2 once over 2hrs 1 week prior to radiation initiation; (subsequent doses): 250mg/m2 once weekly over 1hr for duration of radiation therapy (6–7 weeks). Complete administration 1 hour prior to radiation therapy. Single agent or in combination with platinum-based therapy and 5-FU: Weekly regimen (initial dose): 400mg/m2 once over 2hrs; (subsequent doses): 250mg/m2 once weekly over 1hr; Biweekly regimen (initial and subsequent doses): 500mg/m2 every 2 weeks over 2hrs. Complete administration 1 hour prior to platinum-based therapy with 5-FU. Continue until disease progression or unacceptable toxicity. Dose modifications for toxicity: see full labeling.
Children
Not established.
Erbitux Contraindications
Not Applicable
Erbitux Boxed Warnings
Boxed Warning
Infusion reactions. Cardiopulmonary arrest.
Erbitux Warnings/Precautions
Warnings/Precautions
Monitor for infusion reactions during and for ≥1hr post-infusion; if occurs, immediately interrupt and permanently discontinue based on severity. Increased risk of anaphylactic reactions with history of tick bites, red meat allergy, presence of IgE antibodies against galactose-α-1,3-galactose. Have emergency treatment readily available. Risk of cardiopulmonary arrest and/or sudden death; carefully consider use (w. irradiation or platinum-based therapy with 5-FU) in coronary artery disease, CHF, or arrhythmias. Monitor for pulmonary toxicity; interrupt for acute onset or worsening pulmonary symptoms; permanently discontinue if interstitial lung disease confirmed. Monitor for dermatologic toxicities (eg, acneiform rash, mucocutaneous disease) and infectious sequelae; withhold, reduce dose or permanently discontinue based on severity of reactions. Avoid sun exposure. Monitor electrolytes (eg, magnesium, potassium, calcium) during and for ≥8wks after cetuximab therapy. Embryo-fetal toxicity. Advise females of reproductive potential to use effective contraception during and for 2 months after the last dose. Pregnancy: exclude status prior to initiation. Nursing mothers: not recommended (during and for 2 months after the last dose).
Erbitux Pharmacokinetics
See Literature
Erbitux Interactions
Interactions
Increased mucositis (Grade 3–4), radiation recall syndrome, acneiform rash, cardiac events, and electrolyte disturbances with radiation and cisplatin.
Erbitux Adverse Reactions
Adverse Reactions
Cutaneous reactions (eg, rash, pruritus, nail changes), headache, diarrhea, infection; infusion reactions (may be severe), cardiopulmonary arrest, interstitial lung disease, dermatologic toxicities, electrolyte abnormalities (eg, hypomagnesemia).
Erbitux Clinical Trials
See Literature
Erbitux Note
Not Applicable
Erbitux Patient Counseling
See Literature
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