Product image of Imfinzi (Durvalumab) supplied by GNH India

Imfinzi

Active Ingredient:
Durvalumab
Origin:
EU

Imfinzi (Durvalumab)

Durvalumab, the active ingredient in Imfinzi, is a monoclonal antibody presented as a 500 mg powder for solution for injection for intravenous use. It treats certain advanced cancers, including extensive‑stage small cell lung cancer, unresectable stage III non‑small cell lung cancer after chemoradiation, and selected urothelial, biliary tract and metastatic cancers. It is also indicated for locally advanced or metastatic urothelial carcinoma after platinum‑based chemotherapy, and for biliary tract cancer in combination with chemotherapy.
GNH India supplies Imfinzi as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, oncology centres, pharmacies and clinics worldwide, with established cold‑chain logistics and regulatory support.

Manufacturer / TM Owner

Astrazeneca Ab

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Indications & Clinical Uses

Imfinzi (durvalumab) is a PD‑L1 inhibitor used in several advanced solid‑tumor indications.

  • Extensive‑stage small cell lung cancer (ES‑SCLC): improves overall survival when given as maintenance therapy after first‑line chemotherapy.
  • Unresectable stage III non‑small cell lung cancer (NSCLC) after chemoradiation: serves as consolidation therapy to reduce recurrence.
  • Locally advanced or metastatic urothelial carcinoma after platinum‑based chemotherapy: provides an additional line of treatment to extend disease control.
  • Biliary tract cancer in combination with chemotherapy: used to enhance response rates in patients with advanced disease.

How It Works

  • Durvalumab is a fully human IgG1 monoclonal antibody that binds with high affinity to programmed death‑ligand 1 (PD‑L1) on tumor and immune cells. By blocking the interaction of PD‑L1 with its receptors PD‑1 and CD80, durvalumab prevents the inhibitory signal that suppresses T‑cell activation, thereby restoring anti‑tumor immune responses and allowing cytotoxic T‑cells to recognize and destroy cancer cells.

Side Effects

Imfinzi may be associated with a range of adverse reactions observed in clinical use.

Common Side Effects

  • Fatigue: persistent tiredness reported by patients.
  • Nausea: mild to moderate nausea.
  • Decreased appetite: reduced food intake.
  • Skin rash: mild dermatologic reactions.

Serious or Rare Side Effects

  • Immune‑mediated pneumonitis: inflammation of lung tissue that can be severe.
  • Hepatitis: liver inflammation with elevated enzymes.
  • Endocrine disorders: thyroiditis or adrenal insufficiency requiring hormone replacement.

Precautions & Warnings

Before initiating Imfinzi, clinicians should consider several safety measures.

  • Monitor for immune‑related adverse events: assess organ function regularly.
  • Evaluate for pre‑existing autoimmune disease: consider risk‑benefit before initiating.
  • Conduct baseline and periodic imaging: detect pneumonitis early.
  • Counsel patients on infection signs: report fever or cough promptly.
  • Store at 2‑8 °C: keep refrigerated, protect from light, do not freeze or shake.

Avoid Interactions

Imfinzi can interact with other therapies that affect the immune system or organ function.

Major Interactions (Avoid)

  • Live vaccines: concurrent administration may reduce vaccine efficacy and increase risk.
  • High‑dose corticosteroids: may diminish therapeutic effect.
  • Organ transplant immunosuppression: increased risk of graft rejection.

Moderate Interactions (Monitor Closely)

  • Combination chemotherapy: monitor for overlapping toxicities.
  • Other PD‑1/PD‑L1 inhibitors: avoid sequential use without appropriate washout period.

Frequently Asked Questions

Imfinzi (durvalumab) is approved for several advanced solid‑tumor indications, including extensive‑stage small cell lung cancer, unresectable stage III non‑small cell lung cancer after chemoradiation, locally advanced or metastatic urothelial carcinoma following platinum‑based chemotherapy, and biliary tract cancer when given together with chemotherapy.

Durvalumab is a monoclonal antibody that binds to the programmed death‑ligand 1 (PD‑L1) protein on tumor and immune cells. By blocking PD‑L1 from engaging its receptors PD‑1 and CD80, the drug lifts the inhibitory signal on T‑cells, restoring their ability to recognize and attack cancer cells.

The specific dose and schedule of Imfinzi are determined by the treating physician based on the approved indication, patient weight, and clinical condition. In practice, the product is supplied as a 500 mg vial that is reconstituted and administered intravenously according to the prescriber’s instructions.

Safety data for durvalumab in pregnancy and lactation are limited, and the product is classified as having an unknown pregnancy category. It should only be used when the potential benefit to the mother outweighs any possible risk to the fetus or infant, and the decision should be made in consultation with a healthcare professional.

To request Imfinzi, submit an enquiry on the product page at gnhindia.com, specifying the required quantity. GNH India supplies hospitals, pharmacies and procurement teams worldwide, and will ask for trade or institutional credentials. The sales team then provides pricing, availability, shipping details—including cold‑chain handling where required—and assists with any necessary import documentation.

Imfinzi (durvalumab) shares the same target as other PD‑L1 inhibitors such as atezolizumab and avelumab, but differences exist in dosing intervals, approved indications, and clinical trial outcomes. For example, durvalumab is uniquely approved as consolidation therapy after chemoradiation for stage III NSCLC, whereas atezolizumab has separate approvals for metastatic bladder cancer and first‑line NSCLC.

Imfinzi must be stored in a refrigerator at 2‑8 °C (36‑46 °F). Keep the vial in its original packaging, protect it from light, and do not freeze or shake. Once reconstituted, the solution should be used within the time frame specified in the product labeling and maintained under the same temperature conditions.

The powder is reconstituted with the supplied diluent to create a sterile solution for intravenous infusion. The prepared solution is administered by a healthcare professional, typically over 60 minutes, through an IV line. Administration settings follow standard aseptic techniques and monitoring for infusion‑related reactions.

The most serious immune‑mediated adverse events include pneumonitis (inflammation of lung tissue), hepatitis (liver inflammation), and endocrine disorders such as thyroiditis or adrenal insufficiency. These conditions can be severe or life‑threatening and require prompt medical evaluation, monitoring, and appropriate management, often including corticosteroid therapy.

Imfinzi is contraindicated in patients with known hypersensitivity to durvalumab or any of its excipients. Caution is advised for individuals with active autoimmune diseases, organ transplants, or those receiving systemic immunosuppressants, as the drug may exacerbate underlying conditions or increase the risk of graft rejection.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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