Erbitux
Generic Name
Cetuximab
Manufacturer
Merck KGaA
Country
Germany
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Description
Overview of the medicine
Cetuximab (Erbitux) is a chimeric human-mouse monoclonal antibody that specifically targets and inhibits the epidermal growth factor receptor (EGFR). It is used in the treatment of certain types of metastatic colorectal cancer and head and neck squamous cell carcinoma.
Uses & Indications
Dosage
Adults
Initial dose: 400 mg/m² as a 120-minute IV infusion. Subsequent weekly doses: 250 mg/m² as a 60-minute IV infusion.
Elderly
No specific dose adjustment is typically required.
Renal_impairment
No specific dose adjustment is generally required for mild to moderate renal impairment.
How to Take
Administer via intravenous infusion only, using a dedicated infusion line or a separate lumen. Do not administer as an IV push or bolus. A low-protein binding 0.22 µm or 0.20 µm in-line filter should be used.
Mechanism of Action
Cetuximab binds specifically to the extracellular domain of the EGFR, competitively inhibiting the binding of endogenous ligands such as EGF and TGF-α. This blocks receptor activation and subsequent downstream signaling pathways, leading to inhibition of cell growth, induction of apoptosis, and decreased production of angiogenic factors.
Pharmacokinetics
Onset
Therapeutic effects are typically observed over weeks to months, rather than immediate onset.
Excretion
Primarily through cellular catabolism and proteolytic degradation.
Half life
Approximately 7 days (range 5-10 days).
Absorption
Administered intravenously, resulting in 100% bioavailability.
Metabolism
Catabolized like endogenous IgG antibodies via lysosomal degradation.
Side Effects
Contraindications
- Severe (Grade 3 or 4) hypersensitivity reaction to cetuximab or any component of the formulation.
- Patients with a history of severe or life-threatening hypersensitivity reactions to cetuximab.
- KRAS mutations in metastatic colorectal cancer (mCRC) for the mCRC indication.
Drug Interactions
Radiation therapy
Increased severity of skin toxicity and mucositis.
Platinum-based chemotherapy (e.g., cisplatin)
Increased risk of severe dermatologic and mucosal toxicities.
Fluoropyrimidine chemotherapy (e.g., capecitabine, 5-FU)
Increased incidence of severe diarrhea, stomatitis, and hand-foot syndrome when combined with Erbitux.
Storage
Store refrigerated at 2°C to 8°C (36°F to 46°F). Do not freeze. Protect from light. Do not shake.
Overdose
There is no specific antidote for cetuximab overdose. Management involves supportive care and symptomatic treatment of any adverse reactions.
Pregnancy & Lactation
Pregnancy Category C. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. It is unknown if cetuximab is excreted in human milk; due to the potential for serious adverse reactions in breastfed infants, women should be advised not to breastfeed during treatment and for at least 60 days after the last dose.
Side Effects
Contraindications
- Severe (Grade 3 or 4) hypersensitivity reaction to cetuximab or any component of the formulation.
- Patients with a history of severe or life-threatening hypersensitivity reactions to cetuximab.
- KRAS mutations in metastatic colorectal cancer (mCRC) for the mCRC indication.
Drug Interactions
Radiation therapy
Increased severity of skin toxicity and mucositis.
Platinum-based chemotherapy (e.g., cisplatin)
Increased risk of severe dermatologic and mucosal toxicities.
Fluoropyrimidine chemotherapy (e.g., capecitabine, 5-FU)
Increased incidence of severe diarrhea, stomatitis, and hand-foot syndrome when combined with Erbitux.
Storage
Store refrigerated at 2°C to 8°C (36°F to 46°F). Do not freeze. Protect from light. Do not shake.
Overdose
There is no specific antidote for cetuximab overdose. Management involves supportive care and symptomatic treatment of any adverse reactions.
Pregnancy & Lactation
Pregnancy Category C. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. It is unknown if cetuximab is excreted in human milk; due to the potential for serious adverse reactions in breastfed infants, women should be advised not to breastfeed during treatment and for at least 60 days after the last dose.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
Typically 2-3 years from the date of manufacture when stored under recommended conditions.
Availability
Hospitals, Oncology centers
Approval Status
FDA approved
Patent Status
Patent expired/Biosimilars available in some regions
Clinical Trials
Erbitux has undergone extensive clinical trials that have established its efficacy and safety profile in mCRC and HNSCC. Ongoing research includes studies investigating its role in combination therapies, biomarkers for response, and potential applications in other cancer types.
Lab Monitoring
- Monitor serum electrolytes (especially magnesium, calcium, and potassium) regularly, particularly during and after treatment.
- Monitor for skin toxicity and infusion-related reactions.
- Liver function tests may be monitored periodically.
Doctor Notes
- Pre-medicate patients with an H1-antagonist and potentially a corticosteroid to reduce the incidence and severity of infusion-related reactions.
- Strict monitoring for dermatologic toxicities, including assessment of rash severity, is crucial. Proactive skin care management is recommended.
- Confirm KRAS wild-type status in mCRC patients before initiating treatment to ensure clinical benefit.
Patient Guidelines
- Report any signs of rash, skin changes, itching, fever, chills, or difficulty breathing immediately to your healthcare provider.
- Avoid prolonged sun exposure and use sunscreen and protective clothing while outdoors due to increased photosensitivity.
- Maintain good skin hygiene and moisturize regularly to manage dermatologic side effects.
- Inform your doctor about all other medications you are taking, including over-the-counter drugs and herbal supplements.
Missed Dose Advice
If a dose is missed, administer it as soon as possible. Do not double the next dose. Consult your treating physician to adjust the dosing schedule if necessary.
Driving Precautions
Erbitux may cause fatigue, headache, dizziness, or visual disturbances. Patients should be advised to exercise caution when driving or operating machinery until they know how the drug affects them.
Lifestyle Advice
- Stay well hydrated by drinking plenty of fluids.
- Use gentle, non-irritating skin care products and mild soaps.
- Discuss any changes in appetite or weight with your doctor or a dietitian.
- Avoid harsh chemicals or irritants on the skin.
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