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Suspected adverse reactions reported for Bezlotoxumab
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1 branded products available
MHRA licensed products
View all licensed products for Bezlotoxumab on the MHRA register
Zinplava 1g/40ml concentrate for solution for infusion vials
Merck Sharp & Dohme (UK) Ltd
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(1)
Source: National Institute for Health and Care Excellence (NICE). Contains public sector information licensed under the Open Government Licence v3.0.
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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
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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: 29 · Randomised trials: 8 · 2014–2026
Showing the 50 most relevant studies, sorted by most relevant.
Mohamed MFH, Ward C, Beran A, et al.
2024
- Clostridium Infections
- Cost-Benefit Analysis
- Broadly Neutralizing Antibodies
Keerthi Balaji Babu Naidu, Vinay Chandramouli Bellur, Ananya Prasad, et al.
American Journal of Gastroenterology, 2025
Kanika Sehgal, Parul Berry, Raseen Tariq, et al.
Therapeutic Advances in Gastroenterology, 2025
Background: Clostridioides difficile infection (CDI) treated with bezlotoxumab (BEZ) has been demonstrated to have a lower recurrence rate than placebo in clinical trials. However, real-world data on BEZ’s effectiveness remain limited and heterogeneous. Objectives: To evaluate the real-world effectiveness of BEZ in preventing CDI recurrence through a single-center retrospective cohort and a meta-analysis. Design: A retrospective cohort study and a meta-analysis. Methods: A retrospective study of patients treated with BEZ from 2017 to 2021 was performed at the Mayo Clinic. Demographics, CDI diagnostics, and several prespecified risk factors were analyzed. A literature search was conducted in August 2024 utilizing the Cochrane Central Register of Controlled Trials, Embase, Medline, Scopus, and Web of Science Core Collection. Studies reporting CDI resolution rates with BEZ were included. The random-effects model described by DerSimonian and Laird was used to calculate weighted pooled resolution rates (WPR) with 95% confidence intervals (CI). We assessed heterogeneity with the inconsistency index ( I 2 ) statistic. Results: Across 28 studies and our retrospective cohort, 2639 CDI patients were analyzed. Among 1786 patients treated with BEZ, 1450 achieved clinical resolution (WPR: 81.6%, 95% CI 77.2–85.6%), with significant heterogeneity ( I ² = 77.3%). In subgroup analysis, the pooled relative risk of recurrence was 0.56 (95% CI 0.36–0.88; p < 0.01) for BEZ with SoC compared to SoC alone. A WPR of 83.3% (95% CI 75.5%–91.1%) for patients receiving BEZ with SoC was observed when compared with a WPR of 70.8% (95% CI 62.7%–78.8%) in patients receiving SoC alone on subgroup analysis. In our cohort of 47 patients, the CDI resolution rate was 72.3% (34/47). Conclusion: Our retrospective study and meta-analysis demonstrate the real-world efficacy of BEZ in reducing CDI recurrence. The higher recurrence rates in our cohort likely reflect the high-risk nature of the population, including a greater proportion of immunocompromised patients.
Abstract licence: CC BY-NC 4.0
R. Karkra, Drew Fletcher, R. Goyal, et al.
Gastroenterology, 2025
Abhay Thandavaram, Aneeta Channar, Ansh Purohit, et al.
Cureus, 2022
Abdullah A. Alhifany, Abdulaali R. Almutairi, Thamer A. Almangour, et al.
BMJ Open, 2019
- Fecal Microbiota Transplantation
- Network Meta-Analysis
- Broadly Neutralizing Antibodies
Mark H. Wilcox, Dale N. Gerding, Ian R. Poxton, et al.
New England Journal of Medicine, 2017
- Clostridioides difficile
- Broadly Neutralizing Antibodies
- Anti-Bacterial Agents
Dale N. Gerding, Ciarán P. Kelly, Galia Rahav, et al.
Clinical Infectious Diseases, 2018
- Fecal Microbiota Transplantation
- Fidaxomicin
- Broadly Neutralizing Antibodies
C. Ward, Azizullah Beran, Mohamed Abdallah, et al.
The American Journal of Gastroenterology, 2022
R. Tariq, D. Pardi, S. Khanna
The American Journal of Gastroenterology, 2022
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
19 days
Mechanism
C. difficile infections are caused by two exotoxins, toxin A and toxin B.
Food interactions
None known
Human targets
None mapped
Data: DrugBank · CC BY-NC 4.0
Pharmacokinetics at a glance
Absorption
10 mg/k
[L46976]…
Half-life
19 days
[L360]
Protein binding
Volume of distribution
7.33 L
[L360]
Metabolism
[A260106][L360]
Elimination
[L360]
Clearance
0.317 L
Pharmacokinetic data: DrugBank · CC BY-NC 4.0
[L46976][L47191]
In the US, the drug is approved for use in patients one year of age and older.
[L46976]
In Europe, it is approved in adults only.
[L47191]
Known interactions with other medications. Always consult a healthcare professional.
Showing 50 of 379 interactions
[L46986]
There is no clinical experience with the overdosage of bezlotoxumab.
[L46976]
In clinical trials, healthy subjects received up to 20 mg/kg, which was generally well tolerated.
[L47191]
In case of overdose, patients should be closely monitored for signs or symptoms of adverse reactions, and appropriate symptomatic treatment should be instituted.
[L46976]
Bezlotoxumab binds to C. difficile toxin B and neutralizes it.[L46976] According to the findings of surface plasmon resonance analysis, bezlotoxumab binds to the toxin via two epitopes in the C-terminal CROP domain of the toxin, partially blocking the putative receptor binding pockets and preventing it from binding to host cell receptors.[A260096] Bezlotoxumab does not bind to C. difficile toxin A.[L46976]
The administration of bezlotoxumab plus [actoxumab], another antibody directed against the C. difficile toxin resulted in dose-dependent protection against C. difficile toxin-induced damage and inflammation, as well as a reduced recurrence of C. difficile infection in mice.[A260096]
How the body processes this drug — absorption, distribution, metabolism, and elimination
[L46976]
[L360]
[L360]
[A260106][L360]
[L360]
[L360]
ATC J06BC03
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)
Bezlotoxumab
DrugBank citations
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Structured knowledge from the free knowledge base
ATC classifications (Wikidata)
Linked open data from Wikidata (Q4900370), a free and open knowledge base operated by the Wikimedia Foundation. Data is available under the Creative Commons CC0 1.0 Public Domain Dedication.