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Cetuximab Dosage

Applies to the following strength(s): 2 mg/mL

The information at Drugs.com is not a substitute for medical advice. Always consult your doctor or pharmacist.

Usual Adult Dose for:

Additional dosage information:

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 administered as a 2 hour IV infusion (maximum infusion rate 10 mg /min)
-Maintenance Dose: 250 mg/m2 infused over 1 hour (maximum infusion rate 10 mg/min) once a week

Comments:
-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.
-If given in combination with FOLFIRI, the cetuximab infusion should be completed 1 hour prior to FOLFIRI.
-Patients should be premedicated with an H1 antagonist (e.g., 50 mg of diphenhydramine) IV 30 to 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.

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 Squamous Cell Carcinoma

In combination with radiation therapy or in combination with platinum-based therapy with 5-FU:
-Initial dose: 400 mg/m2 administered as a 2 hour IV infusion (maximum infusion rate 10 mg/min) 1 week prior to initiation of a course of radiation therapy or 1 hour before the initiation of platinum-based therapy with 5-FU
-Maintenance dose: 250 mg/m2 infused over 1 hour (maximum infusion rate 10 mg/min) once a week for the duration of radiation therapy (6 to 7 weeks) or until disease progression or unacceptable toxicity when administered in combination with platinum-based therapy with 5-FU (complete the administration 1 hour prior to radiation therapy or platinum-based therapy with 5-FU)

Monotherapy:
-Initial dose: 400 mg/m2 administered as a 2 hour IV infusion (maximum infusion rate 10 mg/min)
-Maintenance dose: 250 mg/m2 administered as a 1 hour IV infusion (maximum infusion rate 10 mg/min) until disease progression or unacceptable toxicity

Comment:
-Patients should be premedicated with an H1 antagonist (e.g., 50 mg of diphenhydramine) IV 30 to 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.

Uses:
Head and Neck Cancer:
-Locally or regionally advanced squamous cell carcinoma of the head and neck in combination with radiation therapy.
-Recurrent locoregional disease or metastatic squamous cell carcinoma of the head and neck in combination with platinum-based therapy with 5-FU.
-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 modification guidelines for infusion reactions:
-The infusion rate should be reduced by 50% for NCI CTC Grade 1 or 2 and non-serious NCI CTC Grade 3 infusion reactions.
-This drug should be immediately and permanently discontinued for serious infusion reactions, requiring medical intervention and/or hospitalization.

Dose modification guidelines for acneiform rash:
-If a patient experiences a severe skin reaction (NCI-CTC grade 3 or 4) for the first time, therapy should be interrupted for 1 to 2 weeks, until the reaction has improved. If improvement is evident, the infusion can be restarted at 250 mg/m2. If there is no apparent improvement, therapy should be discontinued.
-If a patient experiences a second occurrence of a severe skin reaction, therapy should be interrupted for 1 to 2 weeks until the reaction has improved. If improvement is evident, the infusion can be restarted at the reduced dosage of 200 mg/m2. If no improvement is apparent, therapy should be discontinued.
-If a patient experiences a third occurrence of a severe skin reaction, therapy should be interrupted for 1 to 2 weeks, until the reaction has improved. If improvement is evident, the infusion can be restarted at the reduced dosage of 150 mg/m2. If no improvement is apparent, therapy should be discontinued.
-If a patient experiences a fourth occurrence of a severe skin reaction, therapy should be discontinued.

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 BLACK BOX WARNING:
-Infusion Reactions: Serious infusion reactions have occurred with the administration of this drug in approximately 3% of patients in clinical trials, with fatal outcome reported in less than 1 in 1000. The infusion should be immediately interrupted and this drug should be permanently discontinued for serious infusion reactions.
-Cardiopulmonary Arrest: Cardiopulmonary arrest and/or sudden death have occurred in 2% of patients with squamous cell carcinoma of the head and neck treated with this drug and radiation therapy in Study 1 and in 3% of patients with squamous cell carcinoma of the head and neck treated with European Union (EU)-approved cetuximab in combination with platinum-based therapy with 5-fluorouracil (5-FU) in Study 2. Serum electrolytes, including serum magnesium, potassium, and calcium, should be monitored closely during and after administration of this drug.

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.
-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, necrotising fasciitis or sepsis).
-Appropriate medical resources for the treatment of severe infusion reactions should be available during cetuximab infusions.
-A one hour observation period is recommended following the infusion. Longer observation periods may be required in patients who experience reactions.
-Appropriate medical resources for the treatment of severe infusion reactions should be available during infusions.

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