Durvalumab Injection
Durvalumab Injection (Imfinzi) is an intravenous immunotherapy used to treat several cancers, including lung, biliary tract, liver, endometrial, bladder, and stomach or gastroesophageal junction cancers.
🧬 Where this information comes from Click to expand
The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 1 clinical label set within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →
📖 Durvalumab Injection: Patient Information Guide
A plain-language walkthrough of Durvalumab Injection — what it treats, how it works, how it’s taken, side effects, warnings and interactions. Tap any section to expand it.
What Durvalumab Injection is used for
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Imfinzi (durvalumab) is approved for these adult cancers:
- Resectable non-small cell lung cancer (NSCLC) with no known EGFR mutations or ALK rearrangements: with platinum chemotherapy before surgery, then alone after surgery.
- Unresectable Stage III NSCLC that has not progressed after chemotherapy and radiation: alone.
- Metastatic NSCLC with no sensitizing EGFR mutations or ALK aberrations: with tremelimumab-actl and platinum chemotherapy.
- Limited-stage small cell lung cancer that has not progressed after chemotherapy and radiation: alone.
- Extensive-stage small cell lung cancer: first-line, with etoposide and carboplatin or cisplatin.
- Locally advanced or metastatic biliary tract cancer: with gemcitabine and cisplatin.
- Unresectable hepatocellular carcinoma: with tremelimumab-actl.
- Advanced or recurrent dMMR endometrial cancer: with carboplatin and paclitaxel, then alone.
- BCG-naive, high-risk non-muscle-invasive bladder cancer: with BCG.
- Muscle invasive bladder cancer: with gemcitabine and cisplatin before surgery, then alone after cystectomy.
- Resectable gastric or gastroesophageal junction adenocarcinoma: with FLOT chemotherapy before and after surgery, then alone.
How Durvalumab Injection works
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PD-L1 is a protein found on tumor cells and nearby immune cells. It binds to receptors on T-cells (PD-1 and CD80) and dampens their activity. Durvalumab is a monoclonal antibody that blocks PD-L1 from binding to those receptors.
This releases the brakes on the immune response, so T-cells can become more active against the tumor.
How Durvalumab Injection is taken (dosage)
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Imfinzi is given by a healthcare professional as an IV infusion over about 60 minutes after dilution. The schedule is typically every 2, 3, or 4 weeks, and the length of treatment depends on the cancer.
- Dosing depends on your body weight and the cancer being treated.
- It may be given alone or with chemotherapy, tremelimumab-actl, or BCG.
- Food instructions don’t apply, since it is given by IV.
Follow your prescriber’s plan and the label.
Durvalumab Injection side effects in detail
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Common side effects vary by cancer type and by the drugs given with Imfinzi.
- Fatigue
- Nausea
- Rash
- Constipation
- Diarrhea
- Muscle, joint, or bone pain
- Cough
- Decreased appetite
Serious immune-related reactions and infusion reactions can occur. Report new or worsening symptoms promptly.
Durvalumab Injection warnings and precautions
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The main risk is immune-mediated reactions, which may be severe or fatal. They can affect:
- Lungs (pneumonitis), which is more likely after recent chest radiation
- Bowel (colitis)
- Liver (hepatitis)
- Hormone glands (adrenal, pituitary, thyroid)
- Skin, kidneys, and pancreas
Other risks include infusion reactions, serious complications after allogeneic stem cell transplant, and harm to an unborn baby. Your team may check liver, kidney, and thyroid tests, and may pause or stop treatment.
Durvalumab Injection interactions: what it interacts with
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The label focuses on other treatments used alongside or around Imfinzi.
- Chemotherapy, tremelimumab-actl, or BCG: these are given together with Imfinzi for certain cancers, and the combination may affect side effects.
- Allogeneic stem cell transplant: fatal and other serious complications can occur if it happens before or after PD-1/PD-L1 blocker treatment.
This is not a complete list of interactions. Always talk with your doctor or pharmacist before starting, stopping, or changing any medication.
Before taking Durvalumab Injection
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- Pregnancy: Imfinzi can cause fetal harm. A pregnancy test is advised first, and effective birth control is needed during treatment and for 3 months after the last dose.
- Breastfeeding: do not breastfeed during treatment and for 3 months after the last dose.
- Children: safety and effectiveness have not been established.
- Older adults: no overall differences in safety or effectiveness were seen.
- Prior chest radiation or stem cell transplant: tell your doctor.
- Severe kidney or liver impairment: its effect on how the drug is handled is unknown.
Pharmacodynamics: what Durvalumab Injection does in the body
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Durvalumab given every 4 weeks produces somewhat different blood levels than the every-2-week schedule, including higher peak levels and lower trough levels. Modeling suggests no meaningful differences in effectiveness or safety between the two schedules in people with NSCLC weighing over 30 kg.
Pharmacokinetics: how your body processes Durvalumab Injection
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Steady-state drug levels are reached at about 16 weeks. The terminal half-life is about 21 days. Body weight, age, sex, race, and mild or moderate kidney or liver impairment did not cause clinically significant differences in how the drug is handled. The effect of severe kidney or liver impairment is unknown.
How to store Durvalumab Injection
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Store in a refrigerator at 2°C to 8°C (36°F to 46°F) in original carton to protect from light. Do not freeze.
📄 Written from Durvalumab Injection’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Every point is grounded in that labeling — nothing is invented. How we use AI →
Supplements & herbs that interact with Durvalumab Injection
54 supplements and herbal products have documented interactions with Durvalumab Injection in the licensed clinical database we use. Most are manageable — but your pharmacist should know about everything you take, including vitamins and herbals.
- Moderate · 52
- Minor · 2
Educational information from a licensed clinical database (Natural Medicines) — see our data sources & update cadence. Not medical advice: an interaction being documented does not mean it will happen to you; do not start or stop medications or supplements without professional guidance.
🩺 Durvalumab Injection: pharmacist answers to common questions
Quick, plain-English answers to the questions patients ask most about Durvalumab Injection — the kind of thing our pharmacy team would talk through with you at the counter.
What is Imfinzi used for?
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How will I receive it?
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What side effects should I expect?
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When should I call my care team?
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Is it safe in pregnancy or while breastfeeding?
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Is Durvalumab Injection available over the counter?
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When was Durvalumab Injection first available?
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Who makes Durvalumab Injection?
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💬 Answers drafted from Durvalumab Injection’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Grounded in that labeling — nothing is made up. How we use AI →
🧰 More about Durvalumab Injection on HelloPharmacist
💊 Durvalumab Injection forms and strengths (how it comes)
Durvalumab Injection is available in 1 form. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.
Injection
How this form is used
- Imfinzi is used for certain lung cancers, including non-small cell and small cell lung cancer.
- Imfinzi is used for biliary tract cancer and unresectable hepatocellular carcinoma.
- Imfinzi is used for dMMR endometrial cancer, bladder cancer, and resectable gastric or gastroesophageal junction adenocarcinoma.
- Imfinzi is given as an intravenous infusion over 60 minutes after dilution.
- Imfinzi dosing depends on the cancer being treated and body weight.
- Imfinzi may be given alone or with chemotherapy, tremelimumab-actl, or BCG, depending on the cancer.
📊 Durvalumab Injection on the U.S. market: products, makers and brands
How Durvalumab Injection appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.
Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.
📈 How widely Durvalumab Injection is used (Medicaid data)
A general measure of how commonly Durvalumab Injection is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q1–Q4 2025, summed across every form and brand of the drug.
Think of this as a proxy for how widely Durvalumab Injection is used, drawn from freely available public data. Medicaid is just one program — these numbers don’t include Medicare, other government coverage, or commercial and cash-pay prescriptions, so real-world use is higher than what’s shown here.
How commonly is Durvalumab Injection prescribed? Of the 1,599 medications we measure, Durvalumab Injection ranks #844 by Medicaid prescriptions — more than 47% of them.
Utilization by Durvalumab Injection product
Pick a product to see its own Medicaid numbers. Each chip is one clinical product — a specific strength & dosage form as defined by RxNorm — with brand-name and generic versions combined.
10 ML durvalumab 50 MG/ML Injection Most dispensed
Summed across the 1 of 1 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1919515
2.4 ML durvalumab 50 MG/ML Injection
Summed across the 1 of 1 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1919507
Shares are of the Medicaid prescriptions shown here. Product grouping follows RxNorm (the National Library of Medicine’s drug terminology), so “one product” means one strength & dosage form regardless of manufacturer. Dollar figures are gross Medicaid reimbursement before mandatory rebates — rebates (often large, especially for brand-name drugs) are confidential, so actual net cost to Medicaid is lower than shown.
Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Durvalumab Injection, and across all states and both fee-for-service and managed-care claims. A general popularity signal; it excludes Medicare, commercial insurance and cash prescriptions, so it is not total U.S. use. Based on the 2 of 2 listed Durvalumab Injection NDCs with Medicaid activity.
🔍 Compare Durvalumab Injection products
A representative set of FDA-listed product records for Durvalumab Injection — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)
| Strength | Route | Manufacturer / Labeler | Category ⓘ | Details |
|---|---|---|---|---|
| 💊Injection | ||||
| 120 mg/2.4 mL | — | AstraZeneca AB | DRUG FOR FURTHER PROCESSING | View NDC → |
| 500 mg/10 mL | — | AstraZeneca AB | DRUG FOR FURTHER PROCESSING | View NDC → |
| 120 mg/2.4 mL | Intravenous | AstraZeneca Pharmaceuticals LP × 4 listings | BLA | View NDC → |
| 500 mg/10 mL | Intravenous | AstraZeneca Pharmaceuticals LP × 4 listings | BLA | View NDC → |
| 120 mg/2.4 mL | — | Catalent Indiana, LLC | DRUG FOR FURTHER PROCESSING | View NDC → |
Showing 11 of 11 products — FDA National Drug Code Directory. See every product, package size and price: browse all 11 Durvalumab Injection NDCs →
📈 Durvalumab Injection side effects reported to the FDA (FAERS)
After a medicine reaches the market, patients, doctors and drugmakers can send the FDA reports of problems they think may be linked to it. Here’s what’s been reported for Durvalumab Injection — a signal of what to watch for, not proof the drug caused it.
Source: openFDA, from the FDA Adverse Event Reporting System (FAERS). These are voluntary reports — they don’t prove the drug caused the effect, and counts reflect how often something was reported, not how often it actually happens. Reports also often name the very problem the medicine is taken for — a common reason to file one is that the drug didn’t help — so for a pain reliever you may see “pain” high on the list; that points to why the report was filed, not to the drug causing the symptom. This counts every report that lists Durvalumab Injection in any role, so the total runs higher than the FDA’s official dashboard, which counts only cases where the drug is the suspect. For the authoritative figures, see the FDA FAERS Public Dashboard. Always talk to your pharmacist or doctor.
🏛️ Durvalumab Injection FDA approval history
How Durvalumab Injection went from FDA review to the pharmacy shelf — the key milestones in its regulatory journey.
Source: Drugs@FDA.
🚨 Durvalumab Injection recall history
A recall is when a specific batch of a medicine is pulled from the market — usually a manufacturing issue, not a problem with the drug itself. Class I is most serious, Class III least.
Source: openFDA drug enforcement (recall) reports.
RxNorm Concept Web — From Ingredient to Every Form and Strength
This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.
RxCUI 1919503 1 dose form · 2 strengths
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Dose form (SCDF) Injection RxCUI 1919506In current FDA listingsClinical drug / strength (SCD) 2.4 ML durvalumab 50 MG/MLRxCUI 191950710 ML durvalumab 50 MG/MLRxCUI 1919515
Look up RxCUI 1919503 in the RxCUI Atlas →
RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.
📦 Durvalumab Injection supply and shortage status
Whether Durvalumab Injection is in short supply in the U.S. right now, plus any shortage history the FDA has on record. A shortage usually reflects a manufacturing or demand issue — not a safety problem with the drug.
Source: openFDA, from the FDA Drug Shortages database.
🏷️ Durvalumab Injection brand names
🏭 Who makes Durvalumab Injection: manufacturers and labelers
Durvalumab Injection drug class (RxNorm)
Durvalumab Injection belongs to the Programmed Death Ligand-1 Blocker class.
Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.
🔬 Sources for this Durvalumab Injection page
Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.
How we combine label and product data
HelloPharmacist combines public FDA and NLM records; we don’t author the underlying clinical facts. We identified 1 FDA-filed SPL label set within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. The representative label is the starting point for the displayed reference monograph; the 12 largest stored in-scope SPL records, which may include that representative, are compared section by section, and the longest available version of each section is retained. Forms, routes, brands, labelers, product-listed strengths, and product-record counts are aggregated separately from ingredient-matched FDA NDC Directory records; package records listed above are associated with the linked SPL; and the normalized concept hierarchy comes from NLM RxNorm.
Where a section is identified as AI-written, its plain-language text is generated from bounded label evidence. New draft drug pages remain in the admin review queue before first publication. AstraZeneca Pharmaceuticals LP is the representative DailyMed label linked for verification and dates; it is not the sole source used for the page.
This is general education, not medical advice — always consult your doctor or pharmacist about your medications and any medical condition. For the exact wording of the linked representative label, view that label on DailyMed; some displayed composite sections may come from other in-scope SPL labels. Learn how we use AI and our data sources & update cadence.