Erbitux 500 — Cetuximab 500 mg / 100 mL (1 Vial)

Erbitux is prescribed by an oncologist for the treatment of the following diseases:

• 🔹 Metastatic Colorectal Cancer (Bowel Cancer): In patients with EGFR expression and absence of mutations in the RAS family genes (wild-type KRAS and NRAS genes).
• 🔹 Squamous Cell Carcinoma of the Head and Neck: In combination with radiation therapy for locally advanced forms, or in combination with chemotherapy for recurrent and metastatic cases.

Sales Form: 1 vial contains 500 mg / 100 ml of cetuximab solution (concentration 5 mg/ml).

⚠️ INSTRUCTIONS FOR USE:

• Administration Method: The drug is administered strictly intravenously via drip (infusion). Administration must be performed only by qualified medical personnel in a clinical setting.
• Dosage Regimen: The dose is calculated individually based on the patient's body surface area (m²). Usually, the first (loading) dose is higher than subsequent weekly doses.
• Premedication: Antihistamines and glucocorticosteroids are mandatory before each infusion to prevent allergic reactions.
• Infusion Rate: The first infusion is performed slowly (no more than 5 mg/min); subsequent infusions can be administered faster under condition monitoring.
• Storage: Strictly in the refrigerator at a temperature of 2°C to 8°C. Do not freeze!

• ⛔ Genetic Status: Presence of mutations in RAS genes (KRAS/NRAS) when treating colorectal cancer (in this case, the drug will not be effective).
• ⛔ Hypersensitivity: History of severe allergic reactions (grade 3 or 4) to cetuximab.
• ⛔ Pregnancy and Lactation: Use is contraindicated. Breastfeeding should be discontinued during treatment and for 2 months after the last dose.
• ⛔ Pediatric Use: Efficacy and safety in children under 18 years of age have not been established.

Erbitux therapy may be accompanied by specific reactions, which are often a sign of the drug's effectiveness:

• 🧪 Skin Reactions: Acne-like rash (most common), dry skin, itching, changes in nail structure. The appearance of a rash usually correlates with a good response to treatment.
• 🤒 Infusion Reactions: Fever, chills, dizziness, or shortness of breath during administration.
• 📉 Electrolyte Balance: Decreased blood magnesium levels (hypomagnesemia), less commonly — calcium. Regular biochemical blood analysis is required.
• 🤕 General: Fatigue, nausea, diarrhea, inflammation of the mucous membranes.
• ⚠️ Important: If serious skin lesions or signs of breathing difficulties appear, inform your doctor immediately for dose adjustment or prescription of supportive therapy.