Imfinzi 500mg/10ml Injection by Ernest Impex – Top Exporter from India to USA

Imfinzi 500 mg/10 ml Injection—Advanced PD-L1 Immunotherapy | Global Bulk Supply by Ernest Impex

Imfinzi 500 mg (Durvalumab) is a breakthrough human monoclonal antibody that has revolutionized the landscape of cancer treatment. As a specialized pharmaceutical exporter from India, Ernest Impex (Group of Ernest Pharmaceutical Pvt. Ltd.) ensures the precise cold-chain distribution and bulk supply of Imfinzi 500 mg to high-demand markets, including Washington (USA), London (UK), Canberra (Australia), Bangkok (Thailand), Kingston (Jamaica), and Singapore.

Comprehensive Product Information: Imfinzi 500mg/10ml

1. Formulation & Clinical Classification

• Active Ingredient: Durvalumab (50 mg/mL).

• Concentration: 500 mg of durvalumab in 10 mL of solution.

• Drug Class: Programmed Death-Ligand 1 (PD-L1) Blocking Antibody.

• Mechanism of Action: Imfinzi works by blocking the interaction of PD-L1 with PD-1 and CD80. By inhibiting these "checkpoints," the drug re-activates the patient's own immune system (T-cells) to recognize and effectively attack cancer cells.

2. Therapeutic Indications

Imfinzi is a primary choice for treating several life-threatening malignancies:

• Non-Small Cell Lung Cancer (NSCLC): Specifically for Stage III NSCLC that cannot be removed by surgery and has not progressed after platinum-based chemotherapy and radiation.

• Small Cell Lung Cancer (SCLC): Used in combination with etoposide and carboplatin/cisplatin for extensive-stage SCLC.

• Biliary Tract Cancer (BTC): In combination with gemcitabine and cisplatin for advanced or metastatic BTC.

• Hepatocellular Carcinoma (HCC): Approved for unresectable liver cancer, often in combination with tremelimumab.

• Endometrial Cancer: Used in patients with mismatch repair deficient (dMMR) advanced or recurrent endometrial cancer.

3. Administration and Dosage Protocol

• Standard Adult Dose: Typically administered as 10 mg/kg every 2 weeks or a fixed dose of 1,500 mg every 4 weeks (for patients weighing $\geq 30\text{ kg}$).

• Administration Method: Delivered exclusively as a 1-hour intravenous (IV) infusion by a healthcare professional.

• Dilution: Must be diluted in 0.9% sodium chloride or 5% Dextrose Injection before use.

4. Safety Profile & Immune-Mediated Reactions

Since Imfinzi activates the immune system, it may cause the body to attack normal organs.

• Immune-Mediated Risks: Pneumonitis (lung inflammation), Hepatitis (liver issues), Colitis (intestinal inflammation), and Endocrinopathies (thyroid or adrenal gland issues).

• Common Side Effects: Cough, fatigue, upper respiratory tract infections, and shortness of breath.

• Monitoring: Regular blood tests (liver enzymes, thyroid function, and kidney parameters) are mandatory during treatment.

5. Strict Cold-Chain Storage

• Temperature Control: Must be stored in a refrigerator at 2°C to 8°C (36°F to 46°F).

• Handling: Do not freeze or shake. Keep the vial in the original carton to protect it from light.