Brand Name
Erbitux
Generic Name
Cetuximab
View Brand Information FDA approval date: February 12, 2004
Classification: Epidermal Growth Factor Receptor Antagonist
Form: Solution
What is Erbitux (Cetuximab)?
ERBITUX ® is an epidermal growth factor receptor 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.
Approved To Treat
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Brand Information
ERBITUX (cetuximab)
WARNING: INFUSION REACTIONS and CARDIOPULMONARY ARREST
Infusion Reactions: ERBITUX can cause serious and fatal infusion reactions [see Warnings and Precautions (. Immediately interrupt and permanently discontinue ERBITUX for serious infusion reactions [see Dosage and Administration (.
Cardiopulmonary Arrest: Cardiopulmonary arrest or sudden death occurred in patients with squamous cell carcinoma of the head and neck receiving ERBITUX with radiation therapy or a cetuximab product with platinum-based therapy and fluorouracil. Monitor serum electrolytes, including serum magnesium, potassium, and calcium, during and after ERBITUX administration [see Warnings and Precautions (.
1DOSAGE FORMS AND STRENGTHS
Injection: 100 mg/50 mL (2 mg/mL) or 200 mg/100 mL (2 mg/mL) as a clear, colorless solution in a single-dose vial.
2CONTRAINDICATIONS
None.
3ADVERSE REACTIONS
The following adverse reactions are discussed in greater detail in other sections of the label:
- Infusion reactions
- Cardiopulmonary arrest
- Pulmonary toxicity
- Dermatologic toxicity
- Hypomagnesemia and Electrolyte Abnormalities
3.1Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
The data described in Warnings and Precautions reflect exposure to ERBITUX in 1373 patients with SCCHN or CRC enrolled in clinical trials and treated at the recommended dosage for a median of 7 to 14 weeks
3.2Immunogenicity
As with all therapeutic proteins, there is potential for immunogenicity. The detection of antibody formation is highly dependent on the sensitivity and specificity of the assay. Additionally, the observed incidence of antibody (including neutralizing antibody) positivity in an assay may be influenced by several factors including assay methodology, sample handling, timing of sample collection, concomitant medications, and underlying disease. For these reasons, comparison of the incidence of antibodies to cetuximab in the studies below with the incidence of antibodies to cetuximab in other studies or to other products may be misleading.
An ELISA methodology was used to characterize the incidence of anti-cetuximab antibodies. The incidence of anti-cetuximab binding antibodies in 105 patients (from studies I4E-MC-JXBA, I4E-MC-JXBB, and I4E-MC-JXBD) with at least one post-baseline blood sample (≥4 weeks post first ERBITUX administration) was <5%.
3.3Postmarketing Experience
The following adverse reactions have been identified during post approval use of ERBITUX. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
- Neurologic: Aseptic meningitis
- Gastrointestinal: Mucosal inflammation
- Dermatologic: Stevens-Johnson syndrome, toxic epidermal necrolysis, life-threatening and fatal bullous mucocutaneous disease
4DESCRIPTION
Cetuximab is an epidermal growth factor receptor (EGFR) antagonist. It is a recombinant, human/mouse chimeric monoclonal antibody that binds specifically to the extracellular domain of the human epidermal growth factor receptor (EGFR). Cetuximab is composed of the Fv regions of a murine anti-EGFR antibody with human IgG1 heavy and kappa light chain constant regions and has an approximate molecular weight of 152 kDa. Cetuximab is produced in mammalian (murine myeloma) cell culture.
ERBITUX (cetuximab) injection for intravenous use, is a sterile, preservative-free, clear, colorless solution, which may contain a small amount of visible, white, amorphous cetuximab particulates in a single-dose vial. Each 1 mL of solution contains 2 mg of cetuximab, sodium chloride (8.48 mg), sodium phosphate dibasic heptahydrate (1.88 mg), sodium phosphate monobasic monohydrate (0.41 mg), and Water for Injection, USP at pH of 7.0 to 7.4.