Erbitux Injection

Cetuximab ® 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. 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. 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. Limitations of Use: Cetuximab 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) 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. Squamous Cell Carcinoma of the Head and Neck (SCCHN) Cetuximab ® 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. Abridged from the full prescribing information.

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Source: US FDA prescribing information, via openFDA. Provided for general information only — it is not a substitute for your doctor's or pharmacist's advice. Always follow your prescriber's instructions.

Boxed warning. INFUSION REACTIONS and CARDIOPULMONARY ARREST Infusion Reactions: Cetuximab can cause serious and fatal infusion reactions. Immediately interrupt and permanently discontinue Cetuximab for serious infusion reactions. Cardiopulmonary Arrest: Cardiopulmonary arrest or sudden death occurred in patients with squamous cell carcinoma of the head and neck receiving Cetuximab 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 Cetuximab administration. WARNING: INFUSION REACTIONS and CARDIOPULMONARY ARREST See full prescribing information for complete boxed warning. Cetuximab can cause serious and fatal infusion reactions. Cardiopulmonary arrest or sudden death occurred in patients with squamous cell carcinoma of the head and neck receiving Cetuximab with radiation therapy or with a cetuximab product with platinum-based therapy and fluorouracil. Infusion Reactions: Monitor patients following infusion. Immediately stop and permanently discontinue Cetuximab for serious infusion reactions. Cardiopulmonary Arrest: Monitor serum electrolytes during and after Cetuximab. Pulmonary Toxicity: Interrupt or permanently discontinue for acute onset or worsening of pulmonary symptoms. Dermatologic Toxicity: Monitor for dermatologic toxicities or infectious sequelae. Limit sun exposure. Hypomagnesemia and Accompanying Electrolyte Abnormalities: Monitor during treatment and for at least 8 weeks following the completion. Replete electrolytes as necessary. Increased tumor progression, increased mortality, or lack of benefit observed in patients with Ras-mutant mCRC. Embryo-Fetal Toxicity: Can cause fetal harm. Advise females of potential risk to the fetus and to use effective contraception. Infusion Reactions Cetuximab can cause serious and fatal infusion reactions. Infusion reactions of any grade occurred in 8.4% of 1373 patients who received Cetuximab across clinical trials. Severe (Grades 3 and 4) infusion reactions occurred in 2.2% of patients. Signs and symptoms included rapid onset of airway obstruction (bronchospasm, stridor, hoarseness), hypotension, shock, loss of consciousness, myocardial infarction, and/or cardiac arrest. The risk of anaphylactic reactions may be increased in patients with a history of tick bites, red meat allergy, or in the presence of IgE antibodies directed against galactose-α-1,3-galactose (alpha-gal). Consider testing patients for alpha-gal IgE antibodies using FDA-cleared methods prior to initiating Cetuximab. Negative results for alpha-gal antibodies do not rule out the risk of severe infusion reactions. Abridged from the full prescribing information.

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Source: US FDA prescribing information, via openFDA. Provided for general information only — it is not a substitute for your doctor's or pharmacist's advice. Always follow your prescriber's instructions.

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. The most common adverse reactions (incidence ≥25%) with Cetuximab 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. The most common adverse reactions (>25%) for Cetuximab, in combination with encorafenib, are fatigue, nausea, diarrhea, dermatitis acneiform, abdominal pain, decreased appetite, arthralgia, and rash.. Clinical 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 Cetuximab 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. The most common adverse reactions in clinical trials with Cetuximab as a single-agent or in combination with radiotherapy or chemotherapy [FOLFIRI, irinotecan and 5-fluorouracil/platinum] (incidence ≥25%) include cutaneous adverse reactions (including rash, pruritus, and nail changes), headache, diarrhea, and infection. Squamous Cell Carcinoma of the Head and Neck (SCCHN) In Combination with Radiation Therapy The safety of Cetuximab in combination with radiation therapy compared to radiation therapy alone was evaluated in BONNER. The data described below reflect exposure to Cetuximab in 420 patients with locally or regionally advanced SCCHN. Cetuximab was administered at the recommended dosage (400 mg/m 2 initial dose, followed by 250 mg/m 2 weekly). Patients received a median of 8 infusions (range 1 to 11). Table 2 provides the frequency and severity of adverse reactions in BONNER. Table 2: Selected Adverse Reactions in ≥10% of Patients with Locoregionally Advanced SCCHN (BONNER) a Adverse Reaction Cetuximab with Radiation (n=208) Radiation Therapy Alone (n=212) Grades 1–4 b Grades 3 and 4 Grades 1–4 Grades 3 and 4 a Adverse reactions occurring in ≥10% of patients in the Cetuximab combination arm and at a higher incidence (≥5%) compared to the radiation alone arm. b Adverse reactions were graded using the NCI CTC, version 2.0. Abridged from the full prescribing information.

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Source: US FDA prescribing information, via openFDA. Provided for general information only — it is not a substitute for your doctor's or pharmacist's advice. Always follow your prescriber's instructions.