Updates in the Management of Clostridium Difficile for Adults

Kimberly E. Ng, PharmD, BCPS


US Pharmacist. 2019;44(4):HS9-HS12. 

In This Article

Adjunctive Therapy

Bezlotoxumab (Zinplava), a human monoclonal antibody that binds to C difficile toxin B, was approved in October 2016. It is indicated to reduce recurrence of CDI in patients 18 years of age or older who are receiving antibacterial drug treatment for CDI and are at high risk for CDI recurrence. This medication was approved recently, after the completion of the updated guidelines, and therefore will be included in future guideline updates.[12–14]

Bezlotoxumab is not indicated for the treatment of CDI because it is not an antibacterial drug and should only be used in conjunction with antibacterial drug treatment. Bezlotuxumab inhibits the binding of toxin B and prevents its effects on mammalian cells. It does not bind to C difficile toxin A. The recommended dose is 10 mg/kg as an IV infusion over 60 minutes.[13]

FDA approval was based upon two phase 3 trials, MODIFY I and II. Both studies included more than 1,000 patients in multiple countries and were conducted in both hospital and outpatient settings. The primary outcome was evaluated through 12 weeks following study drug administration. In both MODIFY I and II, CDI recurrence was lower with bezlotoxumab than with placebo in patient groups with prior episodes of CDI, infection with the BI/NAP1/027 strain, severe CDI, age 65 years and older, and compromised immunity. Adverse effects included nausea, pyrexia, and headache. In those with a history of congestive heart failure (CHF), heart failure occurred in 12.7% of bezlotoxumab-treated patients compared with 4.8% in the placebo group. Bezlotoxumab-treated patients also had a higher mortality rate compared with placebo-treated patients. Therefore, in patients with a history of CHF, bezlotoxumab should be reserved for use when the benefits outweigh the risks.[12–14]