Durvalumab 500mg/10ml solution for infusion vials
Requires a prescription from a doctor or prescriber
Safety information for pregnancy and breastfeeding
Pregnancy
Always consult your doctor or midwife before taking any medicine during pregnancy or while breastfeeding. Source: DrugBank (CC BY-NC 4.0).
Official documents, adverse reaction reporting, and safety monitoring
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Safety monitoring data
Yellow Card reports
The MHRA Yellow Card scheme collects reports of suspected side effects from healthcare professionals and patients. View the Drug Analysis Profile (iDAP) for real-world adverse reaction data.
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Suspected adverse reactions reported for Durvalumab
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Submit a Yellow Card report to the MHRA
Data from the MHRA Yellow Card scheme. A reported reaction does not necessarily mean the medicine caused it. Contains public sector information licensed under the Open Government Licence v3.0.
EudraVigilance
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Suspected adverse reactions reported for Durvalumab
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EudraVigilance data is published by the European Medicines Agency (EMA). A suspected adverse reaction is not necessarily caused by the medicine.
1 branded products available
MHRA licensed products
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Imfinzi 500mg/10ml concentrate for solution for infusion vials
Therapeutically similar medicines
Similarity based on WHO Anatomical Therapeutic Chemical (ATC) classification and NHS BNF section grouping. Source data: NHS dm+d via TRUD (OGL v3.0), WHO ATC/DDD Index.
Clinical guidelines and formulary information
British National Formulary
Durvalumab
Source: British National Formulary, NICE. Joint Formulary Committee. Contains public sector information licensed under the Open Government Licence v3.0.
NICE clinical guidance(11)
Durvalumab with gemcitabine and cisplatin for treating unresectable or advanced biliary tract cancer (TA944)
Durvalumab for maintenance treatment of unresectable non-small-cell lung cancer after platinum-based chemoradiation (TA798)
Durvalumab for treating limited-stage small-cell lung cancer after platinum-based chemoradiotherapy (TA1099)
Durvalumab with etoposide and either carboplatin or cisplatin for untreated extensive-stage small-cell lung cancer (TA1041)
Durvalumab with gemcitabine and cisplatin for neoadjuvant treatment then alone for adjuvant treatment of muscle-invasive bladder cancer (TA1138)
Durvalumab with tremelimumab for untreated advanced or unresectable hepatocellular carcinoma (TA1090)
Durvalumab with chemotherapy before surgery (neoadjuvant) then alone after surgery (adjuvant) for treating resectable non-small-cell lung cancer (TA1030)
Durvalumab in combination for untreated extensive-stage small-cell lung cancer (terminated appraisal) (TA662)
Nivolumab with chemotherapy for neoadjuvant treatment then alone for adjuvant treatment of resectable non-small-cell lung cancer (TA1127)
Lung cancer: diagnosis and management (NG122)
Futibatinib for previously treated advanced cholangiocarcinoma with FGFR2 fusion or rearrangement (TA1005)
Source: National Institute for Health and Care Excellence (NICE). Contains public sector information licensed under the Open Government Licence v3.0.
Check stock at pharmacies and supply information
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Supply & product information
Official product databases and supply status monitoring
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Codes for healthcare professionals and prescribing systems
These codes are used by healthcare IT systems and prescribers to identify this medicine.
NHS UK identifiers
Browse tools
SNOMED CT and dm+d codes from NHS TRUD (Technology Reference data Update Distribution), licensed under the Open Government Licence v3.0. BNF codes from NHS Business Services Authority (NHSBSA). ATC codes from the WHO Collaborating Centre for Drug Statistics Methodology (whocc.no).
Active and completed clinical studies from ClinicalTrials.gov
Source: ClinicalTrials.gov, a database of the U.S. National Library of Medicine (NLM), National Institutes of Health (NIH). Data accessed via ClinicalTrials.gov API v2. Trial information is provided for research purposes and does not constitute medical advice.
Pharmacology and chemical data from DrugBank
Key facts
Drug status
Approved
Major interactions
None known
Half-life
18 days
Mechanism
Because cancer cells express antigens that are recognized and taken up by antige…
Food interactions
None known
Human targets
1 target
Data: DrugBank · CC BY-NC 4.0
Pharmacokinetics at a glance
Absorption
3 mg/k
[L12621]
Half-life
18 days
[L12621][L12627]
Protein binding
Volume of distribution
10 mg/k
[L12621][L12627]
Metabolism
[L12627]
Elimination
[L12627]
Clearance
8.2 mL
Pharmacokinetic data: DrugBank · CC BY-NC 4.0
Durvalumab is marketed under the brand name Imfinzi, which is available for intravenous injections. It was granted accelerated approval by the FDA in May 2017 [A192807] for the treatment of selected patients with locally advanced or metastatic urothelial carcinoma.[L12621] In September 2018, durvalumab was approved by the EMA for the treatment of adult patients with locally advanced, unresectable non-small cell lung cancer (NSCLC), only if PD-L1 is expressed in ≥ 1% of tumour cells and there was no observable disease progression following platinum-based chemoradiation therapy.[A192789][L12627] On March 27, 2020, durvalumab was approved by the FDA for use in combination with [etoposide] and either [carboplatin] or [cisplatin] as first-line treatment of patients with extensive-stage small cell lung cancer (ES-SCLC).[L12624] It is additionally approved in Canada under the same name (Imfinzi) for similar indications, as well as the treatment of patients with locally advanced or metastatic urothelial carcinoma. [L53313]
Non-small cell lung cancer (NSCLC)
- unresectable Stage III NSCLC whose disease has not progressed following concurrent platinum-based chemotherapy and radiation therapy.
[L44121]
- metastatic NSCLC with no sensitizing epidermal growth factor receptor (EGFR) mutations or anaplastic lymphoma kinase (ALK) genomic tumour aberrations, in combination with [tremelimumab] and platinum-based chemotherapy.
[L44121][L46188]
- in combination with platinum-containing chemotherapy as neoadjuvant treatment, followed by durvalumab continued as a single agent as adjuvant treatment after surgery, for the treatment of adult patients with resectable (tumours ≥ 4 cm and/or node-positive) NSCLC and no known epidermal growth factor receptor (EGFR) mutations or anaplastic lymphoma kinase (ALK) rearrangements.
[L51209]
Small cell lung cancer (SCLC)
- extensive-stage SCLC in combination with [etoposide] and either [carboplatin] or [cisplatin] as first-line therapy.
[L12624]
- as a monotherapy for limited-stage SCLC in adults whose disease has not progressed following concurrent platinum-based chemotherapy and radiation therapy.
[L51928]
Biliary tract cancer
- locally advanced or metastatic biliary tract cancer (BTC) in combination with [gemcitabine] and [cisplatin].
[L43055]
Hepatocellular carcinoma
- unresectable hepatocellular carcinoma (uHCC) alone or in combination with [tremelimumab].
[L12627][L43647][L46188]
Endometrial cancer
- in combination with [carboplatin] and [paclitaxel] for the first-line treatment of adults with primary advanced or recurrent endometrial cancer who are candidates for systemic therapy. This is followed by maintenance treatment with either durvalumab as monotherapy or in combination with [olaparib] in endometrial cancer that is mismatch repair deficient (dMMR).
[L12627]
Muscle invasive bladder cancer (MIBC)
- in combination with [gemcitabine] and [cisplatin] as neoadjuvant treatment, followed by durvalumab monotherapy as an adjuvant treatment to radical cystectomy in adult patients with MIBC.
[L52915]
Metastatic Urothelial Carcinoma (UC)
- locally advanced or metastatic urothelial carcinoma who have disease progression during or following platinum-containing chemotherapy or have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy.
[L53313]
Gastric or gastroesophageal junction adenocarcinoma
- in combination with fluorouracil, leucovorin, oxaliplatin and docetaxel (FLOT) as neoadjuvant and adjuvant treatment, followed by single-agent durvalumab, is indicated for the treatment of adult patients with resectable gastric or gastroesophageal junction adenocarcinoma (GC/GEJC).
[L54653]
Known interactions with other medications. Always consult a healthcare professional.
Showing 50 of 441 interactions
[L12627]
Based on the findings of clinical studies, durvalumab had a risk of causing immune-mediated reactions, such as pneumonitis, hepatitis, and other serious infections. In animal reproductive studies, durvalumab caused fetal harm and this fetal toxicity may be possible in humans.
[L12621]
The expression of PD-L1 is an adaptive immune response by tumour cells, resulting in the over-expression of the molecule in some cancers.[A192801] PD-L1 interacts with PD-1 and CD80, which leads to blocked cytotoxic T cell activation, T cell proliferation, and cytokine production.[L12621] By binding to PD-L1 and preventing its association with PD-1 and CD80, durvalumab activates the immune responses mediated by cytotoxic T cells that attack tumour cells.[L12621] Durvalumab displays selective and high affinity toward PD-L1 but not PD-L2, which is a regulatory ligand expressed in tumour cells to a lesser extent and involved in regulating inflammation and differentiation of T cells.[A192789]
How the body processes this drug — absorption, distribution, metabolism, and elimination
[L12621]
[L12621][L12627]
[L12621][L12627]
[L12627]
[L12627]
[L12621][L12627]
Proteins and enzymes this drug interacts with in the body
PMID:11015443 PMID:28813410 PMID:28813417 PMID:31399419
As a ligand for the inhibitory receptor PDCD1/PD-1, modulates the activation threshold of T-cells and limits T-cell effector response .
PMID:11015443 PMID:28813410 PMID:28813417 PMID:36727298
Through a yet unknown activating receptor, may costimulate T-cell subsets that predominantly produce interleukin-10 (IL10) .
PMID:10581077
Can also act as a transcription coactivator: in response to hypoxia, translocates into the nucleus via its interaction with phosphorylated STAT3 and promotes transcription of GSDMC, leading to pyroptosis PMID:32929201
ATC L01FF03
Chemical identifiers
CAS, UNII, InChI Key and database cross-references
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Chemical identifiers
CAS, UNII, InChI Key and database cross-references
Linked compound data from DrugBank Open Data (CC BY-NC 4.0)
Durvalumab
DrugBank citations
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