
Cetuxim5 mg/ml
Beacon Pharmaceuticals PLC
Established (FDA-approved) indications RAS wild-type, EGFR-expressing metastatic colorectal cancer (mCRC) (confirmed by an FDA-approved RAS mutation test) and more.
Important: Cetuximab is not indicated for colorectal cancer with RAS mutations (KRAS or NRAS) or when RAS mutation status is unknown, and RAS/BRAF testing must be performed before starting therapy for colorectal cancer. Cetuximab must be prescribed and administered only under the supervision of a qualified oncology specialist.
Cetuximab is administered only by intravenous infusion under the supervision of a physician experienced in the use of antineoplastic agents, with immediate access to equipment and medication needed to manage severe infusion reactions. Premedication with an H1-antihistamine (e.g., diphenhydramine 50 mg IV) is required 30–60 minutes before the first dose and is recommended before subsequent doses.
| Indication | Regimen |
|---|---|
| Metastatic colorectal cancer (RAS wild-type) | Initial dose 400 mg/m² IV over 120 minutes, then 250 mg/m² IV over 60 minutes weekly, in combination with FOLFIRI/irinotecan or as monotherapy, until disease progression or unacceptable toxicity. |
| BRAF V600E-mutant colorectal cancer | Same Cetuximab dosing as above, given in combination with encorafenib, until disease progression or unacceptable toxicity. |
| Head and neck cancer with radiation | Initial dose 400 mg/m² IV over 120 minutes one week before starting radiotherapy, then 250 mg/m² IV over 60 minutes weekly for the duration of radiation therapy (typically 6–7 weeks). |
| Recurrent/metastatic head and neck cancer with platinum-based therapy | Same initial/weekly Cetuximab dosing as above, given in combination with platinum-based chemotherapy plus fluorouracil, followed by Cetuximab monotherapy maintenance until progression or unacceptable toxicity. |
See Dosage and Administration sections for further detail, and Precautions and Warnings for dose-modification rules related to infusion reactions and dermatologic toxicity.
| System | Reaction |
|---|---|
| Dermatologic | Acneiform rash (very common, usually within the first 2 weeks), pruritus, nail changes (paronychia), dry skin, skin fissures |
| General/infusion-related | Infusion reactions (fever, chills, rigors, dyspnea), fatigue, headache |
| Gastrointestinal | Diarrhea, nausea, vomiting, abdominal pain, mucositis (particularly with radiation) |
| Other | Infection, weight loss, radiation dermatitis (when combined with radiotherapy) |
Serious and sometimes fatal infusion reactions, cardiopulmonary arrest/sudden death (particularly with concurrent radiotherapy in head and neck cancer), severe dermatologic toxicity with risk of infection, interstitial lung disease, and severe electrolyte depletion (hypomagnesemia, hypocalcemia, hypokalemia) can occur — see Precautions and Warnings for details.
Cetuximab is contraindicated in patients with known serious hypersensitivity reactions to Cetuximab or any of its components.
Disclaimer
The information provided is accurate to the best of our knowledge, but it does not replace professional medical advice. We cannot guarantee its completeness or accuracy, and the absence of specific information about a drug should not be taken as an endorsement. We are not responsible for any consequences arising from this information, so please consult a healthcare professional for any concerns or questions.