Drug updated on 4/26/2024
| Dosage Form | Injection (intravenous; 1,000 mg/40 mL [25 mg/mL]) |
| Drug Class | Clostridium 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.
Summary
- Bezlotoxumab (Zinplava) is 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.
- Five studies were reviewed, which provided information on the efficacy and safety of bezlotoxumab compared to other interventions such as placebo, actoxumab, fecal microbiota transplantation (FMT), oligofructose, NTCD-M3 spores, rifaximin, RBX2660, etc.
- The pooled analysis from MODIFY 1 & 2 trials showed that bezlotoxumab significantly reduced recurrent CDI rates when compared with placebo. It was also effective both as monotherapy or in combination with actoxumab.
- Network meta-analysis comparisons revealed that bezlotoxumab had an odds ratio of 0.53 against placebo, indicating its effectiveness. It was part of the group associated with a lower incidence than placebo along with oligofructose, etc., rated as moderately confident.
- In terms of preventing recurrent CDIs, bezlotoxumab alone or combined with actoxumab proved more effective than just using actoxumab alone. However, no significant difference was found between FMT and bezlotoxumab, but the latter has better tolerability due to a higher rate of non-serious diarrhea associated with the former.
- The safety profile across studies demonstrated comparable results between bezlotoxumab and placebo without any significant differences in cardiovascular/gastrointestinal events or all-cause mortality, making it a safe option for prevention of recurrent CDIs, especially among high-risk groups like those undergoing vancomycin treatment, inpatients, or infected by specific C. difficile strains like BI/NAP/027.
Product Monograph / Prescribing Information
| Document Title | Year | Source |
|---|---|---|
| Zinplava (bezlotoxumab) prescribing information. | 2016 | Merck & Co Inc., Whitehouse Station, NJ |