Description

Indication & Scope

Durvalumab Injection (Imfinzi®) is a fully human anti-PD-L1 monoclonal antibody. It selectively binds PD-L1, blocks the interaction between PD-L1 and PD-1/CD80, removes immune suppression on T lymphocytes, restores anti-tumor immune activity and enables immune cells to eliminate tumor cells.

Mechanism
PD-L1 immune checkpoint inhibitor, restore endogenous anti-tumor immunity
Drug class
Prescription Monoclonal Antibody / Anti-Cancer Immunotherapy
Clinical use
Stage III NSCLC, Limited-stage SCLC, locally advanced/metastatic biliary tract cancer

Specification

Generic Name	Durvalumab Injection
Brand Name	Imfinzi®
Ingredient	Durvalumab
Dosage Form	Injection
Package	120mg/2.4ml/vial
Conditions Treated	Unresectable Stage III non-small cell lung cancer (NSCLC) in adults whose disease has not progressed after concurrent platinum-based chemoradiotherapy; Limited-stage small cell lung cancer (ES-SCLC) in adults, first-line treatment combined with etoposide plus carboplatin or cisplatin; Locally advanced or metastatic biliary tract cancer (BTC) in adults, first-line treatment combined with gemcitabine and cisplatin
Taboos	Hypersensitivity to durvalumab or any excipients of the formulation
Place of origin	Indiana, USA; Södertälje, Sweden
Priscription Type	Prescription Drug
Storage Conditions	Store at 2°C – 8°C, protect from light. Do not freeze; do not shake.
Manufacturer	Catalent Indiana, LLC; AstraZeneca AB
Registration Authority	National Medical Products Administration (NMPA)
Approval number	SJ20190039
Approval Date	May 23, 2024
Shelf Life	36 months

How to use ?

Recommended Dose: Administer by intravenous infusion after dilution; Patients weighing ≥30kg: 1500mg every 4 weeks or 10mg/kg every 2 weeks; Patients weighing ＜30kg: 10mg/kg every 2 weeks or 20mg/kg every 3 or 4 weeks according to the treatment regimen. Dose adjustment: Dose interruption or permanent discontinuation may be required based on immune-mediated adverse reactions.

Time: The infusion duration shall be no less than 60 minutes.

Interaction: Do not mix with other medicinal products in the same infusion line. Live attenuated vaccines are not recommended during treatment.

Side effects: Immune-mediated pneumonitis, immune-mediated hepatitis, immune-mediated colitis, thyroid dysfunction, rash, pruritus, fatigue, cough, infusion-related reactions.

Important Notice

This product shall only be used for post-exposure rabies prophylaxis by professional medical staff. It must be applied combined with rabies vaccine and injected via wound infiltration plus intramuscular routes as specified. Do not administer intravenously or alter the dosage at will. Hypersensitivity monitoring is required throughout the whole injection process.

Packaging & Shipping

Packaging

Original manufacturer’s packaging with secure export carton. Customized export packaging is available upon request.

Shipping Methods

Express Courier (EMS, DHL, FedEx, UPS), Air Freight, and Sea Freight. Cold-chain transportation is available for products requiring temperature-controlled logistics.

Export Support

Certificate of Analysis

GMP Certificate

Commercial Invoice

Packing List & CPP

Cold Chain Logistics

Customs Documentation

Scientific and regulatory sources

1.WHO References

2.NMPA

3.FDA

4.EMA

FAQ

What is the difference between pembrolizumab and durvalumab?

Pembrolizumab blocks PD-1, a protein on T cells that normally helps keep these cells from attacking other cells in the body, while Imfinzi blocks PD-L1.

How successful is durvalumab?

Durvalumab extended the median overall survival by nearly 2 years.

What should I avoid while taking durvalumab?

Low dose aspirin for heart conditions, may increase your chance of bleeding. Talk to your health care team before you start or stop these medications.

What class is durvalumab?

Durvalumab injection is in a class of medications called monoclonal antibodies.