Colorectal and other GI cancers:
Indications for: ERBITUX
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.
Adult Dosage:
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 Dosage:
Not established.
Boxed Warning:
Infusion reactions. Cardiopulmonary arrest.
ERBITUX 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 Classification:
Epidermal growth factor receptor blocker.
ERBITUX Interactions:
Increased mucositis (Grade 3–4), radiation recall syndrome, acneiform rash, cardiac events, and electrolyte disturbances with radiation and cisplatin.
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).
Note:
Testing considerations: EGFR amplification analysis, K-RAS mutation analysis, BRAF mutation analysis.
Generic Drug Availability:
NO
How Supplied:
Single-dose vials (50mL, 100mL)—1
Head and neck cancer:
Indications for: ERBITUX
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.
Adult Dosage:
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 Dosage:
Not established.
Boxed Warning:
Infusion reactions. Cardiopulmonary arrest.
ERBITUX 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 Classification:
Epidermal growth factor receptor blocker.
ERBITUX Interactions:
Increased mucositis (Grade 3–4), radiation recall syndrome, acneiform rash, cardiac events, and electrolyte disturbances with radiation and cisplatin.
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).
Generic Drug Availability:
NO
How Supplied:
Single-dose vials (50mL, 100mL)—1
