Nivolumab 40mg/4ml solution for infusion vials
Requires a prescription from a doctor or prescriber
Cancer drug, Anti PD-1 monoclonal antibody
Official documents, adverse reaction reporting, and safety monitoring
Report a side effect
Submit a Yellow Card report to the MHRA
Official medicine documents
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.
View Drug Analysis Profile
Suspected adverse reactions reported for Nivolumab
Browse all iDAP reports
Interactive Drug Analysis Profiles for all medicines
Report a side effect
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
The European Medicines Agency (EMA) collects suspected adverse reaction reports from across the EU/EEA through the EudraVigilance system. Search for safety data on this medicine.
View EudraVigilance report
Suspected adverse reactions reported for Nivolumab
About EudraVigilance
Learn about EU pharmacovigilance and safety monitoring
EudraVigilance data is published by the European Medicines Agency (EMA). A suspected adverse reaction is not necessarily caused by the medicine.
3 branded products available
MHRA licensed products
View all licensed products for Nivolumab on the MHRA register
Opdivo 40mg/4ml concentrate for solution for infusion vials
Nivolumab BMS 40mg/4ml concentrate for solution for infusion vials
Bristol-Myers Squibb Pharmaceuticals Ltd
WHO defined daily dose (DDD)
17.1 mg
Not a recommended dose. The DDD is the assumed average maintenance dose per day for a drug used for its main indication in adults. It is a statistical measure used for research and comparison purposes only.
Source: WHO Collaborating Centre for Drug Statistics Methodology, distributed via the NHS dm+d supplementary BNF/ATC mapping files (NHSBSA). Contains public sector information licensed under the Open Government Licence v3.0.
Therapeutically similar medicines
Similarity is based on WHO Anatomical Therapeutic Chemical (ATC) classification and on a factual NHS dm+d therapeutic-grouping code prefix. Source data: NHS dm+d via TRUD (OGL v3.0), WHO ATC/DDD Index.
NHS prescribing volume and spending trends
Guidelines from the National Institute for Health and Care Excellence
NICE clinical guidance(15)
Nivolumab for treating advanced (unresectable or metastatic) melanoma (TA384)
Nivolumab in combination with ipilimumab for treating advanced melanoma (TA400)
Cabozantinib with nivolumab for untreated advanced renal cell carcinoma (TA964)
Nivolumab for previously treated advanced renal cell carcinoma (TA417)
Nivolumab for previously treated unresectable advanced or recurrent oesophageal cancer (TA707)
Nivolumab with ipilimumab for untreated advanced renal cell carcinoma (TA780)
Nivolumab with ipilimumab for untreated unresectable malignant pleural mesothelioma (TA818)
Nivolumab for treating relapsed or refractory classical Hodgkin lymphoma (TA462)
Nivolumab for advanced squamous non-small-cell lung cancer after chemotherapy (TA655)
Nivolumab for adjuvant treatment of invasive urothelial cancer at high risk of recurrence (TA817)
Nivolumab for adjuvant treatment of resected oesophageal or gastro-oesophageal junction cancer (TA746)
Nivolumab for advanced non-squamous non-small-cell lung cancer after chemotherapy (TA713)
Nivolumab with ipilimumab and chemotherapy for untreated metastatic non-small-cell lung cancer (TA724)
Nivolumab with chemotherapy for neoadjuvant treatment of resectable non-small-cell lung cancer (TA876)
Nivolumab for adjuvant treatment of completely resected melanoma with lymph node involvement or metastatic disease (TA684)
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
Pharmacy stock checkers
Search for this medicine at major UK pharmacy chains. These links open the retailer's own website — results depend on their current online catalogue.
Supply & safety information
Official UK regulator monitoring and safety alerts
Pharmacy links redirect to the retailer's own search and do not represent real-time stock levels. Shortage and safety information sourced from MHRA drug safety updates (gov.uk, Crown Copyright under OGL v3.0).
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 code shown is the factual mapping value distributed by NHS Business Services Authority (NHSBSA) in the dm+d supplementary file under OGL v3.0; it is not affiliated with, nor licensed from, the publishers of the British National Formulary. 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.
Academic studies and reviews for this medicine's active substance
Showing the 50 most relevant studies.
Reviews & meta-analyses: 6 · Randomised trials: 38 · 2014–2026
Showing the 50 most relevant studies, sorted by most relevant.
Thomas Cheung Yau, P. Galle, T. Decaens, et al.
Lancet, 2025
John M. Kirkwood, M. Del Vecchio, Jeffrey Weber, et al.
Nature Medicine, 2023
Yelena Y. Janjigian, Kohei Shitara, Markus Moehler, et al.
The Lancet, 2021
- Nivolumab
- Progression-Free Survival
- Immune Checkpoint Inhibitors
Paul Baas, Arnaud Scherpereel, Anna K. Nowak, et al.
The Lancet, 2021
- Antineoplastic Agents, Immunological
- Ipilimumab
- Nivolumab
Yoon‐Koo Kang, Narikazu Boku, Taroh Satoh, et al.
The Lancet, 2017
- Esophagogastric Junction
- Nivolumab
- Adenocarcinoma
F. Stephen Hodi, Vanna Chiarion‐Sileni, René González, et al.
The Lancet Oncology, 2018
- Antineoplastic Agents, Immunological
- Ipilimumab
- Nivolumab
Luis Paz‐Ares, Tudor–Eliade Ciuleanu, Manuel Cobo, et al.
The Lancet Oncology, 2021
- Ipilimumab
- Nivolumab
- Antineoplastic Combined Chemotherapy Protocols
Ken Kato, Byoung Chul Cho, Masanobu Takahashi, et al.
The Lancet Oncology, 2019
Thomas Yau, Joong-Won Park, Richard S Finn, et al.
The Lancet Oncology, 2021
- Sorafenib
- Nivolumab
- Carcinoma, Hepatocellular
F. Stephen Hodi, Jason Chesney, Anna C. Pavlick, et al.
The Lancet Oncology, 2016
- Ipilimumab
- Nivolumab
- Antibodies, Monoclonal
Sources: aggregated from Europe PMC (EMBL-EBI), OpenAlex, Crossref, PubMed and other open scholarly databases. Retracted articles are excluded. Study 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
20 days
Mechanism
The ligands PD-L1 and PD-L2 bind to the PD-1 receptor on T-cells, inhibiting the action of these cells.
Food interactions
None known
Human targets
1 target
Data: DrugBank · CC BY-NC 4.0
Pharmacokinetics at a glance
Absorption
1-4 hours
Half-life
20 days
[A35290]
Protein binding
[L12618]
Volume of distribution
10 mg/k
Metabolism
[L12618]…
Elimination
[L12618]
Clearance
9.4 mL
[A35284]
The clearance rate seems to be increased according to body weight.
[A35290]
Pharmacokinetic data: DrugBank · CC BY-NC 4.0
Nivolumab was granted FDA approval on 22 December 2014.[L12129] It is also available in combination with [relatlimab] under the brand name Opdualag.[L41265][L49996][L50001]
Melanoma
- adult and pediatric (12 years and older) patients with unresectable or metastatic melanoma, alone or in combination with [ipilimumab]
- for the adjuvant treatment of adult and pediatric patients 12 years and older with completely resected Stage IIB, Stage IIC, Stage III, or Stage IV melanoma
- adult and pediatric (12 years and older) patients with unresectable or metastatic melanoma in combination with [relatlimab][L41265][L49996][L50001]
Non-Small Cell Lung Cancer (NSCLC)
- adult patients with resectable (tumors ≥4 cm or node positive) non-small cell lung cancer in the neoadjuvant setting, in combination with platinum-doublet chemotherapy
- adult patients with resectable (tumors ≥4 cm or node positive) non-small cell lung cancer and no known EGFR mutations or ALK rearrangements, for neoadjuvant treatment, in combination with platinum-doublet chemotherapy, followed by single-agent nivolumab as adjuvant treatment after surgery
- adult patients with metastatic non-small cell lung cancer expressing PD-L1 (≥1%) as determined by an FDA-approved test, with no EGFR or ALK genomic tumor aberrations, as first-line treatment in combination with ipilimumab
- adult patients with metastatic or recurrent non-small cell lung cancer with no EGFR or ALK genomic tumor aberrations as first-line treatment, in combination with ipilimumab and 2 cycles of platinum-doublet chemotherapy
- adult patients with metastatic non-small cell lung cancer and progression on or after platinum-based chemotherapy.
Note: Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving nivolumab.
Malignant Pleural Mesothelioma
- adult patients with unresectable malignant pleural mesothelioma, as first-line treatment in combination with ipilimumab
Renal Cell Carcinoma (RCC)
- adult patients with intermediate or poor risk advanced renal cell carcinoma, as a first-line treatment in combination with ipilimumab
- adult patients with advanced renal cell carcinoma, as a first-line treatment in combination with [cabozantinib]
- adult patients with advanced renal cell carcinoma who have received prior anti-angiogenic therapy
Classical Hodgkin Lymphoma (CHL)
- adult patients with classical Hodgkin lymphoma that has relapsed or progressed after autologous hematopoietic stem cell transplantation (HSCT) and [brentuximab vedotin], or 3 or more lines of systemic therapy that includes autologous HSCT
Squamous Cell Carcinoma of the Head and Neck (SCCHN)
- adult patients with recurrent or metastatic squamous cell carcinoma of the head and neck with disease progression on or after a platinum-based therapy
Urothelial Carcinoma
- adjuvant treatment of adult patients with urothelial carcinoma (UC) who are at high risk of recurrence after undergoing radical resection of UC
- adult patients with unresectable or metastatic urothelial carcinoma, as first-line treatment in combination with [cisplatin] and [gemcitabine]
- adult patients with locally advanced or metastatic urothelial carcinoma who:
- have disease progression during or following platinum-containing chemotherapy
- have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy
Colorectal Cancer
- adult and pediatric (12 years and older) patients with unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) colorectal cancer (CRC) in combination with ipilimumab
- adult and pediatric (12 years and older) patients with microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan
Hepatocellular Carcinoma (HCC)
- adult patients with unresectable or metastatic hepatocellular carcinoma (HCC), as a first-line treatment in combination with ipilimumab
- in combination with ipilimumab in adult patients with unresectable or metastatic HCC who have been previously treated with sorafenib
Esophageal Cancer
- adult patients with completely resected esophageal or gastroesophageal junction cancer with residual pathologic disease, who have received neoadjuvant chemoradiotherapy (CRT)
- adult patients with unresectable advanced or metastatic esophageal squamous cell carcinoma as first-line treatment in combination with fluoropyrimidine- and platinum-containing chemotherapy
- adult patients with unresectable advanced or metastatic esophageal squamous cell carcinoma as first-line treatment in combination with ipilimumab
- adult patients with unresectable advanced, recurrent or metastatic esophageal squamous cell carcinoma (ESCC) after prior fluoropyrimidine- and platinum-based chemotherapy
Gastric Cancer, Gastroesophageal Junction Cancer, and Esophageal Adenocarcinoma
- adult patients with advanced or metastatic gastric cancer, gastroesophageal junction cancer, and esophageal adenocarcinoma in combination with fluoropyrimidine- and platinum-containing chemotherapy
- in Canada, nivolumab is specifically approved for the treatment of HER2-negative advanced or metastatic gastric, gastroesophageal junction, or esophageal adenocarcinoma when used in combination with a fluoropyrimidine- and platinum-containing chemotherapy regimen.
[L39040]
Most OPDIVO QVANTIG™ indications align with those for intravenous nivolumab; however, certain indication details differ for this subcutaneous combination formulation.
[L53513]
Known interactions with other medications. Always consult a healthcare professional.
Showing 50 of 416 interactions
[L12129]
Common adverse effects include Rash, pruritus, cough, upper respiratory tract infection, and peripheral edema.
[L12129]
How the body processes this drug — absorption, distribution, metabolism, and elimination
[A35187]
The absorption pharmacokinetic properties respective to the administration of a dose of 10 mg/kg are reported to be Cmax, Tmax and AUC of 242 µg/kg, 2.99 hours and 68100 µg\*h/mL respectively.
[A35285]
[A35290]
[L12618]
[A35285]
At doses ranging from 0.1 to 20 mg/kg the volume of distribution is reported to be 8L.
[A35290]
[L12618]
[L12618]
[A35284]
The clearance rate seems to be increased according to body weight.
[A35290]
Proteins and enzymes this drug interacts with in the body
PMID:21276005 PMID:37208329
Delivers inhibitory signals upon binding to ligands CD274/PDCD1L1 and CD273/PDCD1LG2 .
PMID:21276005
Following T-cell receptor (TCR) engagement, PDCD1 associates with CD3-TCR in the immunological synapse and directly inhibits T-cell activation (By similarity). Suppresses T-cell activation through the recruitment of PTPN11/SHP-2: following ligand-binding, PDCD1 is phosphorylated within the ITSM motif, leading to the recruitment of the protein tyrosine phosphatase PTPN11/SHP-2 that mediates dephosphorylation of key TCR proximal signaling molecules, such as ZAP70, PRKCQ/PKCtheta and CD247/CD3zeta (By similarity)
ATC L01FY02
ATC L01FF01
Chemical identifiers
CAS, UNII, InChI Key and database cross-references
Show
Chemical identifiers
CAS, UNII, InChI Key and database cross-references
Linked compound data from DrugBank Open Data (CC BY-NC 4.0)
Nivolumab
Additional database identifiers
DrugBank citations
If you use DrugBank data in your research, please cite the following publications:
Show earlier publications
Structured knowledge from the free knowledge base
ATC classifications (Wikidata)
Linked open data from Wikidata (Q7041828), a free and open knowledge base operated by the Wikimedia Foundation. Data is available under the Creative Commons CC0 1.0 Public Domain Dedication. WHO INN from the World Health Organization.