
Dose modifications1
Infusion reactions
Reduce the infusion rate by 50% for NCI CTC grade 1 or 2 and non-serious NCI CTC grade 3 infusion reactions. Immediately and permanently discontinue ERBITUX for serious infusion reactions requiring medical intervention and/or hospitalization.
Dermatologic toxicity
Recommended dose modifications for severe (NCI CTC grade 3 or 4) acneiform rash are specified:
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ResetNCI CTC= National Cancer Institute Common Toxicity Criteria.
Dosing Information in Approved Cancer Types
Metastatic colorectal cancer
Indication: 1st line for KRAS wild-type, EGFR-expressing mCRC in combination with FOLFIRI
ERBITUX + FOLFIRI 1st-line dosing1
CRYSTAL=Cetuximab combined with iRinotecan in first-line therapY for metaSTatic 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
- Patients whose tumors have a RAS mutation or whose RAS mutational status is unknown should not receive ERBITUX
- Premedication with an H1 antagonist (eg, 50 mg diphenhydramine) intravenously 30-60 minutes prior to the first dose; premedication should be administered for subsequent doses based upon clinical judgment and presence/severity of prior infusion reactions
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Reset- In the CRYSTAL study, patients received a median of 26 infusions of EU-approved cetuximab (range 1-224)
- In the CRYSTAL study, FOLFIRI was dosed every 2 weeks with the following schedule. FOLFIRI dosing continued until disease progression or unacceptable toxicity occurred
- Irinotecan 180 mg/m2 IV on day 1 of each cycle
- 5-FU 400 mg/m2 IV bolus on day 1 of each cycle followed by 2400 mg/m2 as a 46-hour continuous infusion
- Folinic acid (leucovorin) 400 mg/m2 (racemic) or 200 mg/m2 (L-form) IV on day 1 of each cycle
- Complete ERBITUX administration 1 hour prior to FOLFIRI
- 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
- Do not shake or dilute
5-FU=5-fluorouracil; EGFR=epidermal growth factor receptor; EU=European Union; FOLFIRI=irinotecan, 5-fluorouracil, and leucovorin; IV=intravenous; mCRC=metastatic colorectal cancer.
Locoregionally advanced SCCHN
Indication: Initial treatment for locoregionally advanced SCCHN in combination with RT
ERBITUX + RT dosing schedule for locoregionally advanced SCCHN1
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ResetRecommended dosing for ERBITUX
Week 0
Premedicate with an H1 antagonist (eg, 50 mg diphenhydramine) IV 30-60 minutes prior to the first dose.
ERBITUX initial dose of 400 mg/m2 IV over 2 hours (maximum infusion rate of 10 mg/min) administered 1 week before the start of RT.
Weeks 1-7
Premedication should be administered for subsequent doses based upon clinical judgment and presence/severity of prior infusion reactions. ERBITUX subsequent weekly dose of 250 mg/m2 IV over 1 hour (maximum infusion rate 10 mg/min) for the duration of RT (6-7 weeks).
- 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
- Do not shake or dilute
Radiation therapy
Complete ERBITUX administration 1 hour prior to RT.1 The radiation regimen to be used with ERBITUX is at the discretion of the treating physician.2
IV=intravenous; RT=radiation therapy; SCCHN=squamous cell carcinoma of the head and neck.
Recurrent or metastatic SCCHN
Indication: 1st line for recurrent locoregional or metastatic SCCHN in combination with CT
ERBITUX + platinum-based therapy with 5-FU first-line dosing1
EXTREME=ERBITUX in first-line Treatment of REcurrent or MEtastatic head and neck cancer
Recommended dosage in combination with CT for the first-line treatment of recurrent locoregional or metastatic SCCHN
- Premedication with an H1 antagonist (eg, 50 mg diphenhydramine) intravenously 30-60 minutes prior to the first dose; premedication should be administered for subsequent doses based upon clinical judgment and presence/severity of prior infusion reactions
- ERBITUX loading dose of 400 mg/m2 IV over 2 hours (maximum infusion rate of 10 mg/min) followed by ERBITUX subsequent weekly dose of 250 mg/m2 IV over 1 hour in combination with chemotherapy (maximum infusion rate of 10 mg/min)
- Administer ERBITUX on the day of initiation of CT
- Complete ERBITUX administration at least 1 hour before the start of CT
- Patients should be continued on ERBITUX monotherapy at 250 mg/m2 IV weekly if they have achieved stable disease or better during the combination phase
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Reset- In the EXTREME trial, patients received a median of 17 infusions (range 1-89)
- DO NOT ADMINISTER ERBITUX AS AN INTRAVENOUS PUSH OR BOLUS
- Administer via infusion pump or syringe pump; do not exceed infusion rate of 10 mg/min
- Administer through a low protein binding 0.22-micrometer in-line filter
- Do not shake or dilute
5-FU=5-fluorouracil; CT=platinum-based therapy with 5-FU; IV=intravenous; SCCHN=squamous cell carcinoma of the head and neck; Q3W=every 3 weeks.
REFERENCES
- ERBITUX (cetuximab) [package insert]. Indianapolis, IN: Eli Lilly and Company, its subsidiaries or affiliates.
- Bonner JA, et al. N Engl J Med. 2006;354(6):567-578.