Names and pronunciation
(se-tux′i-mab) Erbitux
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Drug reference
(se-tux′i-mab) Erbitux
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Func. class.: Antineoplastic— miscellaneous
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Chem. class.: Epidermal growth factor receptor inhibitor
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ACTION: Not fully understood; binds to K-RAS wild-type epidermal growth factor receptors (EGFRs); inhibits phos- phorylation and activation of receptor- associated kinase, thereby resulting in inhibition of cell growth
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USES: Alone or in combination with irinotecan for K-RAS wild-type EGFRs expressing metastatic colorectal carci- noma, head/neck cancer
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CONTRAINDICATIONS: Hyper- sensitivity to this product, murine pro- RAS-mutant metastatic colorec- teins, tal cancer or unknown RAS mutation Precautions: Pregnancy, breastfeeding, children, geriatric patients; CV/renal/ hepatic disease; ocular or pulmonary dis- orders, arrhythmias, CAD, radiation/plat- inum-based therapy, respiratory arrest
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Black Box Warning: Infusion-related re- actions, cardiac arrest Black Box Warning: Infusion reactions (bronchospasm, stridor, urticaria, hypo- tension, MI): if mild (grade 1 or 2), re- duce all doses by 50%; if severe (grade 3 or 4), permanently discontinue; moni- tor for at least 1 hr after completion of therapy; reactions usually occur during first dose; have emergency equipment nearby Black Box Warning: Cardiac arrest: monitor electrolytes; in those undergo- ing radiation therapy, electrolytes may be decreased; monitor cardiac patients who receive this product and radiation therapy or platinum-based therapy with 5-FU (head, neck cancer) • Serious hypersensitivity reactions: toxic epidermal necrosis, angioedema, anaphylaxis, Stevens-Johnson syndrome • Monitor serum calcium, magnesium, potassium during and for 8 wk after treat- ment; low levels may occur from a few days to several months after treatment • GI symptoms: frequency of stools, dehydration, abdominal pain, stomatitis • K-RAS mutations with metastatic colorectal carcinoma; if K-RAS mutation on codon 12 or 13 detected, patient should not receive anti-EGFR antibody therapy
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SIDE EFFECTS CNS: Headache, insomnia, depres- sion, aseptic meningitis CV: Cardiac arrest GI: Nausea, diarrhea, vomiting, anorexia, mouth ulceration, dehy- dration, constipation, abdominal pain HEMA: Leukopenia, anemia, neutropenia INTEG: Rash, pruritus, acne, toxic epi- dermal necrolysis, angioedema, acute infusion reactions, other skin toxicities MISC: Conjunctivitis, hypomagnesemia RESP: Interstitial lung disease, cough, dyspnea, pulmonary embolus, respiratory arrest SYST: Anaphylaxis, sepsis, infection, muco- sal inflammation, Stevens-Johnson syn- drome, toxic epidermal necrolysis
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INTERACTIONS Drug/Lab Test Increase: LFTs
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DOSAGE AND ROUTES Squamous cell carcinoma of head/ neck • Adult: IV INFUSION 400 mg/m2 load- ing dose over 120 min, max infusion rate 5 mL/min; weekly maintenance dose (all other infusions) is 250 mg/m2 given over 60 min, max infusion rate 5 mL/min (10 mg/min); premedicate with an H1-antago- nist (diphenhydrAMINE 50 mg IV); dosage adjustments made for infusion reactions or dermatologic toxicity; other protocols used KRAs mutation–negative (wild type), EGFR-expressing colorectal cancer • Adult: IV 400 mg/m2 over 2 hr, then give FOLFIRI after 1 hr, then 250 mg/m2 over 60 min weekly
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Available forms: Solution for injection 2 mg/mL
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Administer: • Premedicate with diphenhydramine 50 mg 30-60 min before first dose; use during infusion for reactions Intermittent IV INFUSION route C • Use cytoxic handling procedures • By IV infusion only; do not give by IV push or bolus; do not shake or dilute • Do not dilute with other products • Store refrigerated at 36°F-46°F (2.2°C to 7.7°C), discard unused portions • Infusion pump: fill Erbitux into sterile evacuated container/bag, repeat until cal- culated volume is put into the container; use new needle for each vial; give through in-line filter (low protein binding 0.22 micrometer); prime before starting infu- sion, max rate 5 mL/min; flush line at end of infusion with 0.9% NaCl • Syringe pump: use in-line filter (low protein binding 0.22 micrometer); con- nect infusion line, start infusion after priming; repeat until calculated volume given • Use new needle and filter for each vial, max 5 mL/min rate; use 0.9% NaCl to flush line after infusion • Do not piggyback • Observe patient for adverse reactions for 1 hr after infusion
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Assess: • Pulmonary changes: lung sounds, cough, dyspnea; interstitial lung disease may occur, may be fatal; discontinue therapy if confirmed
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Evaluate: • Therapeutic response: decreased growth, spread of EGFR-expressing metastatic colorectal, head/neck carcinoma
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CLINICAL CONSIDERATIONS
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Patient and caregiver information: • About the reason for treatment, ex- pected results • To wear sunscreen and hats to limit sun exposure; sun exposure can exacer- bate any skin reactions • To avoid crowds, persons with known infections • Pregnancy/breastfeeding: To report adverse reactions immediately: short- ness of breath, severe abdominal pain, skin eruptions; to use contraception (both female and male) during treatment and for 6 mo after treatment; not to breastfeed during treatment and for 2 mo after treatment
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PHARMACOKINETICS Half-life 114 hr, steady state by third wkly infusion
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• Adult: IV INFUSION 400 mg/m2 load- ing dose over 120 min, max infusion rate 5 mL/min; weekly maintenance dose (all other infusions) is 250 mg/m2 given over 60 min, max infusion rate 5 mL/min (10 mg/min); premedicate with an H1-antago- nist (diphenhydrAMINE 50 mg IV); dosage adjustments made for infusion reactions or dermatologic toxicity; other protocols used KRAs mutation–negative (wild type), EGFR-expressing colorectal cancer
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• Adult: IV 400 mg/m2 over 2 hr, then give FOLFIRI after 1 hr, then 250 mg/m2 over 60 min weekly
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