GNH USA

Europe — EMA

Imfinzi

GNH USA supplies Imfinzi (Durvalumab), a PD‑L1 inhibitor for locally advanced NSCLC, extensive‑stage SCLC, urothelial and biliary tract cancers.

Durvalumab

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What is Durvalumab?

Durvalumab, the active ingredient in Imfinzi, is a monoclonal antibody presented as an intravenous solution for intravenous use. It is indicated for locally advanced or metastatic non‑small cell lung cancer, extensive‑stage small cell lung cancer, urothelial carcinoma and biliary tract cancer in adult patients.

GNH USA supplies Imfinzi as a licensed, GDP‑compliant international pharmaceutical supplier serving oncology centres worldwide. The company follows stringent quality standards and provides cold‑chain logistics for biologic products. Customers receive regulatory documentation and support for import clearance in target markets.

What is Durvalumab used for?

Imfinzi (durvalumab) is a PD‑L1 inhibitor used in several advanced solid‑tumor indications. - Locally advanced or metastatic non‑small cell lung cancer (NSCLC): improves progression‑free survival when given as consolidation therapy after chemoradiation. - Extensive‑stage small cell lung cancer (SCLC): used as maintenance therapy to extend overall survival. - Urothelial carcinoma: indicated for patients with locally advanced or metastatic disease who have progressed following platinum‑based chemotherapy. - Biliary tract cancer: approved for use in adults with unresectable or metastatic disease after prior systemic therapy.

What are the side effects of Durvalumab?

The safety profile of Imfinzi reflects its immunomodulatory activity and includes both common and less frequent adverse reactions.

Common Side Effects: - Fatigue: feeling of tiredness or lack of energy. - Nausea: sensation of needing to vomit. - Diarrhea: loose or watery stools. - Decreased appetite: reduced desire to eat. - Rash: mild skin redness or irritation. - Infusion‑related reactions: transient symptoms such as flushing, chills, or low‑grade fever.

Serious or Rare Side Effects: - Immune‑mediated pneumonitis: inflammation of lung tissue that can impair breathing. - Hepatitis: liver inflammation presenting with elevated enzymes. - Endocrinopathies: thyroiditis, adrenal insufficiency, or hypophysitis affecting hormone balance. - Severe colitis: inflammation of the colon causing abdominal pain and bloody diarrhea. - Nephritis: kidney inflammation that may reduce renal function. - Severe infusion reactions: anaphylaxis or hypotension requiring immediate medical attention.

What precautions apply to Durvalumab?

When using Imfinzi, clinicians should observe specific precautions to minimise risks and ensure optimal handling. - Monitor for immune‑related adverse events: assess organ function regularly and intervene early. - Evaluate pulmonary status before treatment: baseline imaging helps detect early pneumonitis. - Check liver enzymes periodically: identify hepatitis or transaminitis promptly. - Assess endocrine function: screen thyroid and adrenal hormones prior to and during therapy. - Avoid concurrent use with other immune checkpoint inhibitors unless clinically justified: increased toxicity risk. - Store at 2‑8 °C: keep refrigerated, protect from light, do not freeze or shake.

What does Durvalumab interact with?

Imfinzi may interact with other medicines, primarily through additive immune effects or altered pharmacodynamics.

Major Interactions (Avoid): - Concurrent use with other PD‑1/PD‑L1 inhibitors: may amplify immune activation and toxicity. - Live vaccines: increased risk of severe infection; avoid administration during treatment.

Moderate Interactions (Monitor Closely): - Systemic corticosteroids: may diminish therapeutic efficacy if used at high doses. - Immunosuppressive agents (e.g., azathioprine, methotrexate): require close monitoring for reduced antitumor response. - Anticoagulants: monitor for bleeding if severe thrombocytopenia develops.

Frequently asked questions

What conditions is Imfinzi used to treat?+
Imfinzi (durvalumab) is approved for adult patients with locally advanced or metastatic non‑small cell lung cancer, extensive‑stage small cell lung cancer, urothelial carcinoma that has progressed after platinum‑based chemotherapy, and unresectable or metastatic biliary tract cancer following prior systemic therapy.
How does durvalumab work?+
Durvalumab is a fully human IgG1 monoclonal antibody that binds to the programmed death‑ligand 1 (PD‑L1) protein on tumor and immune cells. By blocking PD‑L1’s interaction with PD‑1 and CD80, it lifts the inhibitory signal on T‑cells, allowing the immune system to recognize and attack cancer cells.
What determines the dose of Imfinzi?+
The dose of Imfinzi is determined by the prescribing oncologist based on the approved indication, patient weight, renal and hepatic function, and treatment protocol. The prescribing information provides specific dosing regimens, and the healthcare professional adjusts the schedule according to clinical response and tolerability.
Is Imfinzi safe during pregnancy or breastfeeding?+
The safety of Imfinzi in pregnancy and lactation has not been established. Animal studies have shown potential fetal risk, and there are no adequate human data. Women of childbearing potential should use effective contraception during treatment and for a defined period afterward. Breastfeeding is not recommended while receiving the drug.
How do I order Imfinzi from GNH USA?+
To order Imfinzi, submit an enquiry on the product page at gnh-usa.com, specifying the required quantity. GNH USA supplies hospitals, pharmacies and procurement teams worldwide. After the request, the sales team will verify trade or institutional credentials, then provide pricing, availability, shipping details (including cold‑chain handling) and any necessary import documentation.
How does Imfinzi compare with other PD‑L1 inhibitors?+
Imfinzi (durvalumab) shares the same target class as other PD‑L1 inhibitors such as atezolizumab and avelumab, but differences exist in approved indications, dosing intervals, and clinical trial outcomes. For example, durvalumab is uniquely approved as consolidation therapy after chemoradiation for stage III NSCLC, whereas other agents have distinct label uses.
What are the recommended storage conditions for Imfinzi?+
Imfinzi should be stored at 2 °C to 8 °C (refrigerated). Keep the vials in the original packaging, protect them from light, and avoid freezing or shaking. If the product must be transported, maintain the cold‑chain using validated insulated containers with temperature monitoring.
How is Imfinzi administered to patients?+
Imfinzi is given as an intravenous infusion by a qualified healthcare professional. The infusion is typically administered over 60 minutes, with the option to extend the time if infusion‑related reactions occur. The exact schedule (e.g., every two weeks) follows the approved dosing regimen for each indication.
What are the most serious risks to watch for with Imfinzi?+
Serious risks include immune‑mediated pneumonitis, hepatitis, severe colitis, nephritis, endocrinopathies (such as thyroiditis or adrenal insufficiency), and severe infusion reactions like anaphylaxis. Patients should be monitored regularly for signs of organ inflammation, and any severe symptoms should prompt immediate medical evaluation.
Who should not use Imfinzi?+
Imfinzi is contraindicated in patients with a known hypersensitivity to durvalumab or any of its excipients. It should also be avoided in individuals receiving live vaccines during treatment, and in patients with uncontrolled autoimmune diseases where immune activation could exacerbate the condition.
Information provided on this page is for educational use by procurement and clinical professionals. Always consult a licensed healthcare provider for medical advice and prescribing decisions. GNH USA supplies this product subject to applicable regulatory and licensing requirements.

Product details

Drug
Durvalumab
Route
Intravenous Use
Manufacturer
Astrazeneca Ab
Origin
EU

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