Formulation and specifications: Injection: 100mg (20ml)/bottle
Indications: For the treatment of metastatic colorectal cancer with RAS, BRAF gene wild type: in combination with FOLFOX or FOLFIRI regimen for first-line treatment; in combination with irinotecan for patients who have failed irinotecan-containing therapy.
Key points for rational drug use:
1. The RAS gene status must be tested using validated methods prior to dosing. RAS gene wild type is a prerequisite for cetuximab treatment, and this product is not intended for the treatment of patients with mutant RAS genotype or unknown RAS status.
2. Translational therapy: Patients with colorectal cancer with combined liver metastases and/or lung metastases, potentially resectable, may choose cetuximab in combination with chemotherapy (RAS wild type).
3. Palliative treatment: patients with metastatic colorectal cancer (RAS wild type) in first and second line treatment, especially patients with left hemi-intestinal cancer, can choose cetuximab + chemotherapy. For patients who did not use cetuximab in first and second line treatment (RAS wild type), cetuximab combined with irinotecan chemotherapy can be chosen.
4. If initial treatment with cetuximab is effective (CR/PR/SD) and progression is followed by second- or second-line treatment without cetuximab and progression occurs again, cetuximab in combination with irinotecan may be considered for re-challenge therapy if the RAS gene remains wild-type.
5. This product often causes varying degrees of skin toxicity, mainly in the form of acne-like rash, and such patients should be protected from light during administration. Mild to moderate skin toxicity reactions do not require dose adjustment, while those with severe skin toxicity reactions should have their doses reduced as appropriate.
6. The incidence of severe infusion reactions is 3%, and the lethality rate is less than 0.1%. Ninety percent of these occur at the time of first administration and are characterized by sudden airway obstruction, urticaria, and hypotension. Patients must be treated with antihistamines and glucocorticoids prior to the first drip of this product, and it is recommended that this treatment be given to patients prior to each subsequent dose of this product.
7. This product has only been studied in patients with normal hepatic and renal function (serum creatinine ≤ 1.5 times the upper limit of normal, transaminases ≤ 5 times the upper limit of normal, and bilirubin ≤ 1.5 times the upper limit of normal).
8. This product should be stored at 2~8℃, freezing is prohibited, and should be used immediately after opening.