Classifications: antineoplastic; monoclonal antibody; epidermal growth factor receptor (egfr) inhibitor; Therapeutic:antineoplastic; monoclonal antibody; egfr inhibitor
Pregnancy Category: C
100 mg/50 mL injection
Cetuximab is a recombinant, monoclonal antibody that binds specifically to the epidermal growth factor receptor (EGFR, HER1,
c-ErbB-1) on both normal and tumor cells. Binding to the EGFR results in inhibition of cell growth, induction of apoptosis,
and decreased vascular endothelial growth factor production.
Overexpression of EGFR is detected in many human cancers, including those of the colon and rectum. Cetuximab inhibits the
growth and survival of tumor cells that overexpress the EGFR.
Treatment of EGFR-expressing metastatic colorectal cancer in combination with irinotecan in patients who are refractory to
irinotecan-based chemotherapy or as monotherapy in patients who are intolerant to irinotecan-based chemotherapy. Used in
combination with radiation for squamous cell cancer of head and neck.
Pregnancy (category C), lactation within 60 d of using cetuximab; worsening of preexisting pulmonary edema or interstitial
lung disease. Safety and efficacy in children have not been established.
Infusion reaction, especially with first time users; history of hypersensitivity to murine proteins or cetuximab; cardiac
disease, coronary artery disease; pulmonary disease, pulmonary fibrosis; UV exposure, radiation therapy.
Route & Dosage
|Colorectal Cancer/Head and Neck Cancer
Adult: IV Start with 400 mg/m2 over 2 h; continue with 250 mg/m2 over 1 h weekly
- Administer with full resuscitation equipment available and under the supervision of a physician experienced with chemotherapy.
- Premedication with an H1-receptor antagonist (e.g., diphenhydramine 50 mg IV) is recommended.
- Monitor for an infusion reaction for at least 1 h following completion of infusion.
PREPARE: IV Infusion: Do not shake or further dilute vial. Do not mix with other medication. Inject cetuximab solution into a sterile, evacuated
container or bag (i.e., glass, polyolefin, ethylene vinyl acetate, DEHP plasticized PVC, or PVC); repeat until needed dose
has been added to container, using a new needle for each vial. Attach to infusion set with a low-protein-binding 0.22-micron
filter and prime line with cetuximab. May also administer by syringe and syringe pump; use a new needle and filter for each
ADMINISTER: IV Infusion: ??Do NOT administer a bolus dose. Give IV infusion via an infusion pump or syringe pump at ≤5
mL/min; piggyback into the patient's IV line.??Flush line with NS after infusion.??Note: Slow infusion rate by 50% if a prior, mild infusion reaction occurred.
INCOMPATIBILITIES Solution/additive: Do not mix with other additives. Y-site: No data available.
- Store unopened vials at 2°8° C (36°46° F). Note: Vials may contain a small amount of easily
visible, white particles.
- Cetuximab in IV bag is stable for up to 12 h refrigerated and up to 8 h at 20°25° C (68°77°
Adverse Effects (≥1%) Body as a Whole:
Infusion reactions (allergic reaction, anaphylactoid reaction, fever, chills, dyspnea
, bronchospasm stridor, hoarseness,
urticaria, hypotension), fever,
sepsis, asthenia, malaise,
. CNS: Headache, insomnia
Cardiopulmonary arrest. GI: Nausea, vomiting, diarrhea, abdominal pain, constipation, stomatitis
, dyspepsia. Hematologic: Leukopenia
Weight loss, peripheral edema, dehydration, hypomagnesemia, hypokalemia. Respiratory: Pulmonary
embolism, pulmonary fibrosis (rare), dyspnea,
cough. Skin: Rash, alopecia
, pruritus. Urogenital:
None reported to date.
114 h (75188 h).
Assessment & Drug Effects
- Discontinue infusion and notify physician for S&S of a severe infusion reaction: chills, fever, bronchospasm, stridor, hoarseness,
urticaria, and/or hypotension. Institute supportive measures immediately, including epinephrine, corticosteroids, IV antihistamines,
bronchodilators, and oxygen. Carefully monitor until complete resolution of all S&S.
- Monitor pulmonary status and report onset of acute or worsening pulmonary symptoms.
- Lab tests: Periodic CBC with differential, Hct and Hgb.
Patient & Family Education
- Report immediately: especially difficulty breathing, wheezing, shortness of breath, hives, faintness and/or dizziness anytime
during IV infusion.
- Report promptly any of the following: eye inflammation, mouth sores, skin rash, redness, or severe dry skin.
- Wear sunscreen and a hat and limit sun exposure while being treated with this drug.