ERBITUX 2 mg/mL
cetuximab · SOLUTION · ImClone LLC
Erbitux (cetuximab) is an intravenous medication that works by blocking epidermal growth factor receptors on cancer cells to slow or stop their growth. It is used to treat certain types of head and neck cancer and colorectal cancer.
Key Facts
- Brand Name
- ERBITUX
- Generic Name
- cetuximab
- NDC Code (Product)
66733-958- Manufacturer
- ImClone LLC
- Strength
- 2 mg/mL
- Dosage Form
- SOLUTION
- Route
- INTRAVENOUS
- Marketing Status
- Application #
- BLA125084
- Drug Class
- Epidermal Growth Factor Receptor Antagonist [EPC]
- Marketing Start
- 10/02/2007
Recall History
Eli Lilly & Co
Labeling: Missing label; potential for missing primary container label on the vial.
Infusion Options, Inc.
Lack of Assurance of Sterility
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE ERBITUX ® is an epidermal growth factor receptor (EGFR) antagonist indicated for treatment of: Head and Neck Cancer Locally or regionally advanced squamous cell carcinoma of the head and neck in combination with radiation therapy. ( 1.1 , 14.1 ) Recurrent locoregional disease or metastatic squamous cell carcinoma of the head and neck in combination with platinum-based therapy with fluorouracil. ( 1.1 , 14.1 ) Recurrent or metastatic squamous cell carcinoma of the head and neck progressing after platinum-based therapy. ( 1.1 , 14.1 ) Colorectal Cancer K-Ras wild-type, EGFR-expressing, metastatic colorectal cancer as determined by an FDA-approved test 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. ( 1.2 , 5.7 , 12.1 , 14.2 ) 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. ( 5.7 ) BRAF V600E Mutation-Positive Metastatic Colorectal C…
Dosage & Administration
2 DOSAGE AND ADMINISTRATION Premedicate with an H 1 receptor antagonist. ( 2.4 ) In Combination With Radiation Therapy: Initial dose: 400 mg/m 2 administered as a 120-minute intravenous infusion one week prior to initiating a course of radiation therapy. ( 2.2 ) Subsequent doses: 250 mg/m 2 administered as a 60-minute infusion every week for the duration of radiation therapy (6–7 weeks). ( 2.2 ) Complete ERBITUX administration 1 hour prior to radiation therapy. ( 2.2 ) As Single-Agent or in Combination With Chemotherapy: Weekly: Administer initial dose of 400 mg/m 2 as a 120-minute intravenous infusion, and subsequent doses of 250 mg/m 2 infused over 60 minutes once weekly. ( 2.2 , 2.3 ) Biweekly: Administer 500 mg/m 2 as a 120-minute intravenous infusion every two weeks. ( 2.2 , 2.3 ) Complete ERBITUX administration 1 hour prior to chemotherapy. Continue treatment until disease progression or unacceptable toxicity. ( 2.2 , 2.3 ) See full prescribing information for dosage adjustments for adverse reactions. ( 2.5 ) 2.1 Patient Selection Select patients with metastatic colorectal cancer (CRC) for treatment with ERBITUX based on the presence of: Ras wild-type, EGFR-expressing CRC [se…
Contraindications
4 CONTRAINDICATIONS None. None. ( 4 )
Adverse Reactions
6 ADVERSE REACTIONS The following adverse reactions are discussed in greater detail in other sections of the label: Infusion reactions [see Warnings and Precautions ( 5.1 )] . Cardiopulmonary arrest [see Warnings and Precautions ( 5.2 )] . Pulmonary toxicity [see Warnings and Precautions ( 5.3 )] . Dermatologic toxicity [see Warnings and Precautions ( 5.4 )] . Hypomagnesemia and Electrolyte Abnormalities [see Warnings and Precautions ( 5.6 )] . The most common adverse reactions (incidence ≥25%) with Erbitux as a single-agent or in combination with radiotherapy or chemotherapy (FOLFIRI, Irinotecan and 5-Fluorouracil/Platinum) are: cutaneous adverse reactions (including rash, pruritus, and nail changes), headache, diarrhea, and infection. ( 6 ) The most common adverse reactions (>25%) for ERBITUX, in combination with encorafenib, are fatigue, nausea, diarrhea, dermatitis acneiform, abdominal pain, decreased appetite, arthralgia, and rash. ( 6 ). To report SUSPECTED ADVERSE REACTIONS, contact Eli Lilly and Company at 1-800-LillyRx (1-800-545-5979) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying…
Frequently Asked Questions
What is ERBITUX used for?
Erbitux (cetuximab) is an intravenous medication that works by blocking epidermal growth factor receptors on cancer cells to slow or stop their growth. It is used to treat certain types of head and neck cancer and colorectal cancer.
Is ERBITUX a controlled substance?
ERBITUX is not classified as a controlled substance by the DEA.
What is the generic name for ERBITUX?
The generic name for ERBITUX is cetuximab. There are no other listed brand versions of cetuximab.
What is the NDC code for ERBITUX 2 mg/mL?
The NDC (National Drug Code) for ERBITUX 2 mg/mL is 66733-958, listed by ImClone LLC.
Other ERBITUX Dosages
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)