Tislelizumab 100mg/10ml solution for infusion vials
Requires a prescription from a doctor or prescriber
Tislelizumab is a humanized monoclonal IgG4 antibody against programmed death receptor-1 (PD-1).
Safety information for pregnancy and breastfeeding
Pregnancy
Animal reproduction studies have not been conducted with tislelizumab.
Human IgG4 (immunoglobulins) are known to cross the placental barrier.
Women should be advised of the potential risk to a fetus.
No clinical data are available on the possible effects of tislelizumab on fertility.
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 Tislelizumab
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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.
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Suspected adverse reactions reported for Tislelizumab
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.
1 branded products available
MHRA licensed products
View all licensed products for Tislelizumab on the MHRA register
Tevimbra 100mg/10ml concentrate for solution for infusion vials
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
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. 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
23.8 days
Mechanism
Binding of the PD-1 ligands PD-L1 and PD-L2, to the PD-1 receptor found on T cel…
Food interactions
None known
Human targets
1 target
Data: DrugBank · CC BY-NC 4.0
Pharmacokinetics at a glance
Absorption
0.5 to 10 mg/k
Half-life
23.8 days
Protein binding
Volume of distribution
6.42 L
Metabolism
[L49349]
Clearance
0.153 l
[L49349]
Pharmacokinetic data: DrugBank · CC BY-NC 4.0
On September 25, 2023, tislelizumab gained EMA approval as a monotherapy for adults with esophageal cancer under the brand name TEVIMBRA. This approval was based on positive results demonstrated in the RATIONALE 302 study, where an 8.6-month median overall survival rate was observed for tislelizumab treatment compared to 6.3-month for chemotherapy.[L49439] Tislelizumab was also approved by the FDA on March 14, 2024.[L50346] It has subsequently been approved for additional cancers in the US and EU. [L49349]
Tislelizumab, in combination with platinum-containing chemotherapy, is indicated as a first-line treatment in adults with unresectable or metastatic ESCC whose tumors express PD-L1.
[L52310]
Tislelizumab, as a monotherapy, is indicated for the treatment of adults with:
- Unresectable ESCC [L49349][L52310]
- Locally advanced ESCC [L49349]
- Metastatic ESCC following prior systemic chemotherapy that did not include a PD-(L)1 inhibitor, such as platinum-based chemotherapy.
[L49349][L52310]
Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma
Tislelizumab, in combination with platinum and fluoropyrimidine-based chemotherapy, is indicated for the first-line treatment of adults with unresectable or metastatic HER2-negative gastric or GEJ adenocarcinoma whose tumors express PD-L1.
[L52310]
Extensive-Stage Small Cell Lung Cancer
In the EU, tislelizumab is indicated in combination with [etoposide] and platinum chemotherapy for the first-line treatment of adult patients with extensive-stage SCLC.
[L49349]
Non-Small Cell Lung Cancer (NSCLC)
In the EU, tislelizumab is approved as a monotherapy for adults with locally advanced or metastatic NSCLC after prior platinum-based therapy. For patients with EGFR mutant or ALK-positive NSCLC, targeted therapies should have been received prior to tislelizumab.
[L49349]
Non-Squamous NSCLC
In combination with [pemetrexed] and platinum-containing chemotherapy, tislelizumab is indicated for the first-line treatment of adults with non-squamous NSCLC whose tumors:
- Have PD-L1 expression on ≥50% of tumor cells
- Have no EGFR or ALK-positive mutations and who have either: Locally advanced NSCLC not eligible for surgical resection or platinum-based chemoradiation, or Metastatic NSCLC.
[L49349]
Squamous NSCLC
In combination with [carboplatin] and either [paclitaxel] or nab-paclitaxel, tislelizumab is indicated for the first-line treatment of adults with squamous NSCLC who have either: Locally advanced NSCLC not eligible for surgical resection or platinum-based chemoradiation, or Metastatic NSCLC.
[L49349]
Known interactions with other medicines. Always consult a healthcare professional.
Showing 50 of 417 interactions
[L49349]
Animal reproduction studies have not been conducted with tislelizumab. However, in murine models of pregnancy, blockade of PD-1/PD-L1 signaling has been shown to disrupt tolerance to the fetus and result in increased fetal loss.
[L49349]
Human IgG4 (immunoglobulins) are known to cross the placental barrier.
Therefore, tislelizumab, being an IgG4 variant, has the potential to be transmitted from the mother to the developing fetus.
[L49349]
Women should be advised of the potential risk to a fetus. Tislelizumab should not be used during pregnancy unless the clinical condition of the woman requires treatment with tislelizumab.
[L49349]
No clinical data are available on the possible effects of tislelizumab on fertility. No reproductive and development toxicity studies have been conducted with tislelizumab.
Based on a 3-month repeat-dose toxicity study, there were no notable effects in the male and female reproductive organs in cynomolgus monkeys when tislelizumab was given at doses of 3, 10, or 30 mg/kg every 2 weeks for 13 weeks (7 dose administrations).
[L49349]
There is no information on overdose with tislelizumab. In case of overdose, patients should be closely monitored for signs or symptoms of adverse drug reactions, and appropriate symptomatic treatment should be instituted immediately.
[L49349]
Tislelizumab is a humanized immunoglobulin G4 (IgG4) variant monoclonal antibody against PD-1, binding to the extracellular domain of human PD-1. It competitively blocks the binding of both PD-L1 and PD-L2, inhibiting PD-1-mediated negative signalling and enhancing the functional activity in T cells in in vitro cell-based assays.[L49349]
How the body processes this drug — absorption, distribution, metabolism, and elimination
[L49349]
The time to reach 90% steady-state level is approximately 84 days (12 weeks) after 200 mg doses once every 3 weeks, and the steady-state accumulation ratio of tislelizumab PK exposure is approximately 2-fold.
[L49349]
Tislelizumab is administered intravenously and therefore is immediately and completely bioavailable.
[L49349]
[L49349]
[L49349]
[L49349]
[L49349]
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 L01FF09
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)
Tislelizumab
DrugBank citations
If you use DrugBank data in your research, please cite:
- DrugBank 6.02024Recommended citationKnox C., Wilson M., Klinger C.M., et alDrugBank 6.0: the DrugBank Knowledgebase for 2024Nucleic Acids Res. 2024 Jan 552(D1):D1265-D1275
- DrugBank 5.02018Wishart D.S., Feunang Y.D., Guo A.C., et alDrugBank 5.0: a major update to the DrugBank database for 2018Nucleic Acids Res. 2017 Nov 846(D1):D1074-D1082
- DrugBank 4.02014Law V., Knox C., Djoumbou Y., et alDrugBank 4.0: shedding new light on drug metabolismNucleic Acids Res. 2014 Jan 142(1):D1091-7
- DrugBank 3.02011Knox C., Law V., Jewison T., et alDrugBank 3.0: a comprehensive resource for 'omics' research on drugsNucleic Acids Res. 2011 Jan39(Database issue):D1035-41
- DrugBank 2.02008Wishart D.S., Knox C., Guo A.C., et alDrugBank: a knowledgebase for drugs, drug actions and drug targets.Nucleic Acids Research2008 Jan36(Database issue):D901-6
- DrugBank 1.02006Wishart D.S., Knox C., Guo A.C., et alDrugBank: a comprehensive resource for in silico drug discovery and exploration.Nucleic Acids Research2006 Jan 134(Database issue):D668-72
Structured knowledge from the free knowledge base
Linked open data from Wikidata (Q28209583), a free and open knowledge base operated by the Wikimedia Foundation. Data is available under the Creative Commons CC0 1.0 Public Domain Dedication.