Bezlotoxumab

(Zinplava®)

Zinplava®

Drug updated on 10/30/2024

Dosage FormInjection (intravenous; 1,000 mg/40 mL [25 mg/mL])
Drug ClassClostridium difficile toxin B-binding human monoclonal antibodies
Ongoing and
Completed Studies
ClinicalTrials.gov

Indication

  • Indicated to reduce recurrence of Clostridioides difficile infection (CDI) in adults and pediatric patients 1 year of age and older who are receiving antibacterial drug treatment for CDI and are at a high risk for CDI recurrence.

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Summary
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  • This summary is based on the review of four systematic review(s)/meta-analysis(es). [1-4]
  • Recurrent Clostridioides difficile Infection (rCDI) Reduction: Bezlotoxumab (BEZ) significantly reduced rCDI rates compared to standard care (SOC), with a pooled rCDI rate of 15.8% in BEZ-treated patients versus 28.9% in those receiving SOC, demonstrating a relative risk (RR) of 0.57 (95% CI: 0.45–0.72).
  • MODIFY Trial Findings: In the MODIFY trials, BEZ was associated with a 10.0% absolute reduction in rCDI risk compared to placebo (16.5% vs. 26.6%; 95% CI -14.0 to -6.0; p<0.0001), with a number needed to treat (NNT) of 10 to prevent one rCDI event.
  • Comparative Effectiveness with FMT and Other Interventions: Bezlotoxumab showed similar effectiveness to fecal microbiota transplantation (FMT) in rCDI resolution but with significantly lower rates of diarrhea compared to FMT, particularly when used with standard antibiotic therapy (SAT).
  • Mortality and Heart Failure Risk: No significant differences in overall mortality or heart failure risk were observed in patients receiving bezlotoxumab (BEZ) compared to standard care (SOC), though caution was noted for patients with a history of congestive heart failure.
  • Adverse Events (AEs): Bezlotoxumab with standard antibiotic therapy (SAT) was associated with significantly lower rates of non-serious diarrhea compared to fecal microbiota transplantation (FMT), which showed a higher incidence of this AE.
  • No population types or subgroups information is available.

Product Monograph / Prescribing Information

Document TitleYearSource
Zinplava (bezlotoxumab) Prescribing Information.2023Merck & Co Inc., Whitehouse Station, NJ

Systematic Reviews / Meta-Analyses

Clinical Practice Guidelines