INDICATIONS AND USAGE（适应症）

Squamous Cell Carcinoma of the Head and Neck (SCCHN)

ERBITUX® is indicated:

in combination with radiation therapy for the initial treatment of locally or regionally advanced squamous cell carcinoma of the head and neck (SCCHN).

in combination with platinum-based therapy with fluorouracil for the first-line treatment of patients with recurrent locoregional disease or metastatic SCCHN.

as a single-agent for the treatment of patients with recurrent or metastatic SCCHN for whom prior platinum-based therapy has failed.

K-Ras Wild-type, EGFR-expressing Colorectal Cancer (CRC)

ERBITUX is indicated for the treatment of K-Ras wild-type, epidermal growth factor receptor (EGFR)-expressing, metastatic colorectal cancer (mCRC) as determined by an FDA-approved test:

in combination with FOLFIRI (irinotecan, fluorouracil, leucovorin) 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.

Limitations of Use: ERBITUX is not indicated for treatment of Ras-mutant colorectal cancer or when the results of the Ras mutation tests are unknown.

BRAF V600E Mutation-Positive Metastatic Colorectal Cancer (CRC)

ERBITUX is indicated, in combination with encorafenib, for the treatment of adult patients with metastatic colorectal cancer (CRC) with a BRAF V600E mutation, as detected by an FDA-approved test, after prior therapy.

DOSAGE（服用剂量）

Recommended Dosage for Squamous Cell Carcinoma of the Head and Neck (SCCHN)

In combination with radiation therapy

Initial dose: 400 mg/m2 administered as a 120-minute intravenous infusion one week prior to initiating a course of radiation therapy.

Subsequent doses: 250 mg/m2 administered as a 60-minute infusion every week for the duration of radiation therapy (6–7 weeks).

Complete ERBITUX administration 1 hour prior to radiation therapy.

As a single-agent or in combination with platinum-based therapy and fluorouracil

Administer Erbitux as a single-agent or in combination with platinum-based therapy and fluorouracil on a weekly or biweekly schedule.

Weekly Dosage

Initial dose: 400 mg/m2 administered as a 120-minute intravenous infusion

Subsequent doses: 250 mg/m2 administered as a 60-minute infusion every week

Biweekly Dosage

Initial and subsequent doses: 500 mg/m2 administered as a 120-minute intravenous infusion every 2 weeks

Complete ERBITUX administration 1 hour prior to platinum-based therapy with fluorouracil. Continue treatment until disease progression or unacceptable toxicity.

Recommended Dosage for Colorectal Cancer (CRC)

As a single-agent or in combination with irinotecan or FOLFIRI (irinotecan, fluorouracil, leucovorin)

Administer Erbitux as a single-agent or in combination with irinotecan or FOLFIRI (irinotecan, fluorouracil, leucovorin) on a weekly or biweekly schedule.

Weekly Dosage

Initial dose: 400 mg/m2 administered as a 120-minute intravenous infusion

Subsequent doses: 250 mg/m2 administered as a 60-minute infusion every week

Biweekly Dosage

Initial and subsequent doses: 500 mg/m2 administered as a 120-minute intravenous infusion every 2 weeks

Complete ERBITUX administration 1 hour prior to irinotecan or FOLFIRI. Continue treatment until disease progression or unacceptable toxicity.

In combination with encorafenib

The recommended initial dose is 400 mg/m2 administered as a 120-minute intravenous infusion in combination with encorafenib.

The recommended subsequent dosage is 250 mg/m2 weekly as a 60-minute infusion in combination with encorafenib until disease progression or unacceptable toxicity.

Refer to the encorafenib prescribing information for recommended encorafenib dosage information.

ADVERSE REACTIONS（不良反应）

Infusion reactions

Cardiopulmonary arrest

Pulmonary toxicity

Dermatologic toxicity

Hypomagnesemia and Electrolyte Abnormalities

For full information, please refer to:

https://nctr-crs.fda.gov/fdalabel/services/spl/set-ids/8bc6397e-4bd8-4d37-a007-a327e4da34d9/spl-doc?hl=Cetuximab

Erbituxinformation