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Erbitux

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Cetuximab (Cetuximab) Instructions
Common name: Cetuximab
Trade name: Erbitux
All names: Cetuximab, Erbitux, Cetuximab injection, Cetuximab, Erbitux


Indications:
Erbitux and irinotecan (irinotecan) are used together, and the treatment contains irinotecan Metastatic colorectal cancer in patients with epidermal growth factor receptor phenotype who failed cytotoxic therapy.


Usage and dosage:
The recommended starting dose is 400mg/㎡, the infusion time is 120 minutes, and the drip rate should be controlled within 5ml/min. The maintenance dose is 250 mg/㎡ per week, and the infusion time is no less than 60 minutes.
Administration of H1 receptor blockers in advance can play a certain role in preventing infusion reactions.
Do not shake or dilute before use.


Adverse reactions:
The most common side effects in the central nervous system are discomfort (Malaise), fever, and headache
In the skin, acne-like rash (acneform) rash; 90%, 10% are severe forms), and sunlight will worsen skin symptoms, so try to avoid exposure to the sun during medication
Other side effects such as gastrointestinal discomfort, nausea, vomiting, difficulty breathing, fatigue


Contraindications:
Erbitux is contraindicated in patients with known severe allergic reactions to cetuximab.


Notes:
1. An allergy test should be conducted before using this product. Inject 20mg of this product intravenously and observe for more than 10 minutes. Patients with positive results should use it with caution, but negative results cannot completely rule out the occurrence of severe allergic reactions.
2. This product can often cause varying degrees of skin toxic reactions. Such patients should pay attention to avoid light during use. There is no need to adjust the dose for mild to moderate skin toxic reactions. Those who experience severe skin toxic reactions should reduce the dose as appropriate.
3. The incidence rate of severe infusion reactions is 3%, and the fatality rate is less than 0.1%. 90% of them occur during the first use and are characterized by sudden airway obstruction, urticaria and hypotension. Because some infusion reactions occur during the subsequent medication phase, medication should be administered under the supervision of a doctor. When a mild to moderate infusion reaction occurs, the infusion rate can be slowed down or antihistamine drugs can be taken. If a severe infusion reaction occurs, the infusion must be stopped immediately, epinephrine, glucocorticoids, antihistamine drugs should be injected intravenously, and treatments such as bronchodilators and oxygen infusion should be given. Some patients should be prohibited from using this product again. In addition, if acute onset of pulmonary symptoms occurs during the use of this product, it should be stopped immediately and the cause should be identified. If it is indeed an interstitial pulmonary disease, it should be disabled and treated accordingly.


Storage:
Medicines should be placed in a refrigerator at 2 to 8 degrees Celsius (do not freeze); if they deteriorate or expire, they cannot be used again.


Mechanism of action:
This product can specifically bind to the EGF receptor expressed on the surface of normal cells and various cancer cells, and competitively block the binding of EGF and other ligands, such as α transforming growth factor (TGF-α). This product is an IgG1 monoclonal antibody against the EGF receptor. After the two specifically combine, it blocks the intracellular signal transduction pathway by inhibiting the tyrosine kinase (TK) that binds to the EGF receptor, thereby inhibiting the proliferation of cancer cells, inducing apoptosis of cancer cells, and reducing the production of matrix metalloproteinases and vascular endothelial growth factors.


Safety and efficacy:
A multi-center randomized phase II clinical controlled study evaluated the efficacy of this product in the treatment of metastatic colorectal cancer. Among 329 subjects with overexpression of EGF receptors, 206 were male, with an average age of 59 (26-84 years old), 58% were colon cancer patients, and 40% were rectal cancer patients. 63% of the patients were ineffective after treatment with oxaliplatin. In the study, patients were randomly divided into 2 groups, 218 patients in the combination group of this product and irinotecan, and 111 patients in the single use group of this product. The initial dose of this product is 400 mg one week, followed by 250 mg one week. The endpoint of treatment is disease progression or the occurrence of intolerable adverse reactions. The dosage of irinotecan is 350 mg/m2 every 3 weeks, 180 mg/m2 every 2 weeks, or 125 mg/m2 four times in the 6th week. The results showed that the effective rates of the combined treatment group and this product alone were 22.9% and 10.8% respectively. The average duration of efficacy was 5.7 and 4.2 months in the combined treatment group and this product alone group, respectively; compared with this product alone group, patients in the combination treatment group significantly delayed the progression of the disease. Another multicenter, single-group, open-label clinical study evaluated the efficacy of this product in combination with irinotecan in 138 patients with metastatic colorectal cancer overexpressing EGF receptors. All patients had previously received irinotecan treatment, and 74 of them still showed overexpression of EGF receptors after treatment. The initial dose of cetuximab is 400 mg weekly, followed by 250 mg weekly until disease progression or intolerable adverse effects occur. The dosage of irinotecan is 350 mg/m2 every 3 weeks, 180 mg/m2 every 2 weeks, or 125 mg/m2 4 times every 6 weeks. The overall effective rate was 15%, and the average duration of effect was 6.5 months, while the effective rate in the irinotecan-ineffective group was 12%, and the average duration of effect was 6.7 months.
Another multi-center single-group open clinical study evaluated the efficacy of this product alone in the treatment of 57 patients with metastatic colorectal cancer with overexpression of EGF receptors. The patients had all previously received irinotecan treatment, and 28 of them still showed overexpression of EGF receptors after treatment with irinotecan. After treatment with this product, the total effective rate was 9%, of which the effective rate in the irinotecan-ineffective group was 14%, and the average time to disease progression was 1.4 and 1.3 months respectively. The average duration of efficacy in both groups was 4.2 months.