VECTIBIX 20MG/ML CONC. SOLUTION FOR INFUSION 20 mg/ml Concentrate for solution for infusion 5ml Vial

Product Overview

VECTIBIX 20mg/ml Concentrate for solution for infusion contains Panitumumab, a human monoclonal antibody used in the treatment of certain types of cancer.

It is specifically designed to target the epidermal growth factor receptor (EGFR), which plays a crucial role in cell growth and division, making it an effective therapy for specific patient populations.

As a prescription medicine, VECTIBIX must always be administered under the direct guidance and supervision of a qualified healthcare professional in a clinical setting.

Each 5ml vial provides a concentrated solution for intravenous infusion, ensuring precise dosing for optimal therapeutic outcomes.

Benefits of Use

• Targets the epidermal growth factor receptor (EGFR), effectively inhibiting cancer cell growth and proliferation.
• Primarily used in the treatment of metastatic colorectal cancer (mCRC) in specific patient populations, often determined by biomarker testing.
• May be utilized as a monotherapy or in combination with certain chemotherapy regimens, as carefully determined by the treating physician based on individual patient needs.
• Offers a targeted approach to cancer therapy, minimizing impact on healthy cells compared to traditional chemotherapy.

How to Use

VECTIBIX is a specialized medication administered exclusively by healthcare professionals in a controlled clinical environment. Detailed preparation and administration instructions are provided below:

1. VECTIBIX is supplied as a concentrate and requires careful dilution with an appropriate diluent (e.g., sodium chloride 9 mg/ml (0.9%) solution for injection) before intravenous administration.
2. The diluted solution is then administered as an intravenous infusion. A typical 100 mg dose is infused over approximately 60 minutes, while a 200 mg dose usually requires about 90 minutes. Infusion duration may be adjusted for higher doses or based on patient tolerance.
3. The precise recommended dosage, frequency, and duration of administration will be meticulously determined by your treating physician. This decision will be based on your specific medical condition, body weight, and response to treatment.
4. It is absolutely crucial to strictly adhere to all instructions provided by your healthcare provider and the comprehensive product prescribing information for correct preparation, administration, and ongoing patient monitoring.
5. Do not attempt to self-administer this medication.

Caution & Warnings

• VECTIBIX carries a risk of severe infusion-related reactions. Patients must be closely monitored during the infusion period and for a specified time post-infusion for any signs of adverse reactions.
• Dermatological toxicities, including various forms of rash, dry skin, erythema, and pruritus, are very common. Severe skin reactions may necessitate dose modification, temporary interruption, or even permanent discontinuation of treatment.
• Cases of pulmonary fibrosis and interstitial lung disease have been reported. Patients should be diligently monitored for the development of new or worsening pulmonary symptoms, such as dyspnea, cough, or fever.
• Electrolyte disturbances, particularly hypomagnesemia, are a known side effect. Regular monitoring of serum electrolyte levels, especially magnesium, calcium, and potassium, is highly recommended during treatment.
• VECTIBIX is contraindicated in patients with a history of severe hypersensitivity reactions to panitumumab or any of its excipients.
• This medication should not be used during pregnancy or while breastfeeding due to potential harm to the fetus or infant. Women of childbearing potential are advised to use effective contraception during treatment and for a minimum of 2 months after the last dose.
• VECTIBIX is strictly for hospital or clinic use and must not be self-administered under any circumstances.
• Patients should be screened for RAS mutation status prior to initiation of treatment, as efficacy is limited in patients with mutated RAS.

Ingredients

• Active Ingredient: Panitumumab
• Other Ingredients: Sodium chloride, sodium acetate trihydrate, acetic acid, water for injections.

Product Details

• Product Type: Concentrate for solution for infusion
• Strength: 20 mg/ml
• Volume per Vial: 5ml
• Total Panitumumab per Vial: 100 mg
• Manufacturer: Amgen
• Storage: Store in a refrigerator (2°C to 8°C). Do not freeze. Keep the vial in the outer carton to protect from light.
• Legal Status: Prescription Only Medicine (POM)
• Therapeutic Class: Antineoplastic agent, Monoclonal antibody