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Cetuximab Dosage

Medically reviewed by Drugs.com. Last updated on May 29, 2020.

Applies to the following strengths: 2 mg/mL

Usual Adult Dose for Colorectal Cancer

Either as monotherapy or in combination with irinotecan or FOLFIRI (irinotecan, 5-fluorouracil, leucovorin):
-Initial Dose: 400 mg/m2 IV over 120 minutes (maximum infusion rate 10 mg/min)
-Maintenance Dose: 250 mg/m2 IV over 60 minutes once a week (maximum infusion rate 10 mg/min)

Comments:
-Determine EGFR-expression status using FDA-approved tests prior to initiating therapy. Also confirm the absence of a Ras mutation prior to initiation of therapy.
-If given in combination with FOLFIRI, the cetuximab infusion should be completed 1 hour prior to FOLFIRI.
-Premedicate with an H1 antagonist (e.g., 50 mg diphenhydramine) IV 30 to 60 minutes prior to the first dose.
-Premedication should be administered for subsequent doses based upon clinical judgment.

Uses:
Colorectal Cancer:
-K-Ras wild-type, EGFR-expressing, metastatic colorectal cancer as determined by approved tests.
-In combination with FOLFIRI for first-line treatment.
-In combination with irinotecan in patients who are refractory to irinotecan-based chemotherapy.
-As a single agent in patients who have failed oxaliplatin- and irinotecan-based chemotherapy or who are intolerant to irinotecan.

Usual Adult Dose for Head and Neck Cancer

In combination with radiation therapy or platinum-based therapy and fluorouracil:
-Initial dose: 400 mg/m2 IV over 120 minutes administered one week prior to a course of radiation therapy or on the first day of platinum-based therapy and fluorouracil
-Maintenance dose: 250 mg/m2 IV over 60 minutes once a week for the duration of radiation therapy (6 to 7 weeks) or until disease progression or unacceptable toxicity (complete cetuximab administration 1 hour prior to radiation therapy or platinum-based therapy with fluorouracil)

Monotherapy:
-Initial dose: 400 mg/m2 IV over 120 minutes
-Maintenance dose: 250 mg/m2 IV over 60 minutes once a week until disease progression or unacceptable toxicity

Comments:
-Premedicate with an H1 antagonist (e.g., 50 mg diphenhydramine) IV 30 to 60 minutes prior to the first dose.
-Premedication should be administered for subsequent doses based upon clinical judgment.

Uses:
Head and Neck Cancer:
-Locally or regionally advanced squamous cell carcinoma of the head and neck in combination with radiation.
-Recurrent locoregional disease or metastatic squamous cell carcinoma of the head and neck in combination with platinum-based therapy with fluorouracil.
-Recurrent or metastatic squamous cell carcinoma of the head and neck progressing after platinum-based therapy.

Renal Dose Adjustments

Data not available

Liver Dose Adjustments

Data not available

Dose Adjustments

Dose Modifications for Adverse Reactions:
INFUSION REACTIONS:
-Grade 1 or 2: Reduce infusion rate by 50%.
-Grade 3 or 4: Immediately and permanently discontinue therapy.
DERMATOLOGIC TOXICITIES AND INFECTIOUS SEQUELAE (e.g., acneiform rash, mucocutaneous disease):
-First occurrence Grade 3 or 4: Delay infusion 1 to 2 weeks; if improvement, continue at 250 mg/m2; if no improvement, discontinue therapy.
-Second occurrence Grade 3 or 4: Delay infusion 1 to 2 weeks; if improvement, continue at 200 mg/m2; if no improvement, discontinue therapy.
-Third occurrence Grade 3 or 4: Delay infusion 1 to 2 weeks; if improvement, continue at 150 mg/m2; if no improvement, discontinue therapy.
-Fourth occurrence Grade 3 or 4: Discontinue therapy.
PULMONARY TOXICITY:
-Acute onset or worsening pulmonary symptoms: Delay infusion 1 to 2 weeks; if improvement, continue at the dose that was being administered at the time of occurrence; if no improvement in 2 weeks or interstitial lung disease (ILD) is confirmed, discontinue therapy.

For the dosage or recommended dose modifications of concomitantly used chemotherapeutic agents, refer to the product information for these products. They must not be administered earlier than 1 hour after the end of the cetuximab infusion.

Precautions

US BOXED WARNINGS:
Infusion Reactions:
-This drug can cause serious and fatal infusion reactions. Interrupt and permanently discontinue therapy for serious infusion reactions.
Cardiopulmonary Arrest:
-This drug can cause cardiopulmonary arrest or sudden death in patients with squamous cell carcinoma of the head and neck receiving this drug with radiation therapy or with platinum-based therapy and fluorouracil. Monitor serum electrolytes (e.g., serum magnesium, potassium, and calcium) during and after administration.

CONTRAINDICATIONS:
-None

Safety and efficacy have not been established in patients younger than 18 years.

Consult WARNINGS section for additional precautions.

Dialysis

Data not available

Other Comments

Administration advice:
-This drug should only be administered under supervision of specialists with experience in prescribing antineoplastic agents, and in a setting where resuscitation equipment is available.
-Premedication with an antihistamine is recommended before all infusions.
-For the dosage or recommended dose modifications of concomitantly used chemotherapeutic agents, refer to the product information for these medicinal products. They must not be administered earlier than 1 hour after the end of the cetuximab infusion.
-Do not administer this drug as an IV push or bolus.
-Skin lesions induced by this drug may predispose patients to superinfections (e.g., S. aureus), which may lead to complications, (e.g., cellulitis, erysipelas, or, potentially with fatal outcome, staphylococcal scalded skin syndrome, necrotizing fasciitis or sepsis).
-Appropriate medical resources for the treatment of severe infusion reactions should be available during infusions.
-A one hour observation period is recommended following the infusion. Longer observation periods may be required in patients who experience reactions.

General:
-This drug is not indicated for treatment of Ras-mutant colorectal cancer.

Reconstitution/preparation techniques:
-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.
-Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. The solution should be clear and colorless and may contain a small amount of easily visible, white, amorphous, cetuximab particulates.
-Do not shake or dilute.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.