Fidaxomicin

(Dificid®)

Fidaxomicin

Drug updated on 11/1/2024

Dosage FormTablet (oral; 200 mg); Suspension (oral; 40 mg/mL)
Drug ClassMacrolide antibacterials
Ongoing and
Completed Studies
ClinicalTrials.gov

Indication

  • Indicated in adult and pediatric patients 6 months of age and older for the treatment of C
  • difficile-associated diarrhea.

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Summary
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  • This summary is based on the review of eight systematic review(s)/meta-analysis(es). [1-8]
  • Fidaxomicin and vancomycin demonstrate equivalent effectiveness as first-line treatments for mild to moderate CDI (Clostridium difficile infection), with no significant difference in general efficacy.
  • Fidaxomicin shows significantly lower recurrence rates than vancomycin at 40 days (RR (relative risk) = 0.52, 95% CI (confidence interval): 0.38-0.70, P < .01), 60 days (RR = 0.38, 95% CI: 0.21-0.69, P < .01), and 90 days (RR = 0.62, 95% CI: 0.50-0.77, P < .01). Cadazolid also reduces recurrence compared to vancomycin (pooled OR (odds ratio) = 0.71; 95% CI = 0.52 to 0.98; P = 0.04).
  • Fidaxomicin improves 60-day all-cause mortality compared to vancomycin (RR = 0.57, 95% CI: 0.34-0.96, P = .03) and has superior sustained cure rates compared to vancomycin (OR: 1.61; 95% CrI: 1.27, 2.05) and metronidazole (OR: 2.39; 95% CrI: 1.65, 3.47).
  • Fidaxomicin and vancomycin exhibited no significant differences in the incidence of clinical adverse reactions, all-cause mortality at 40 days, severe CDI, or recurrent CDI.
  • Cadazolid showed a similar adverse event profile to vancomycin, with no significant differences in clinical cure rates or sustained clinical response.
  • In severe CDI, vancomycin is more effective than fidaxomicin (RR = 0.94, 95% CI: 0.90-0.98, P < .01); for CDI in patients with inflammatory bowel disease (IBD), fidaxomicin or vancomycin is recommended for initial episodes, while fecal microbiota transplantation (FMT) is suggested for recurrent cases.

Product Monograph / Prescribing Information

Document TitleYearSource
Dificid (fidaxomicin) Prescribing Information.2022Merck & Co., Inc., Rahway, NJ

Systematic Reviews / Meta-Analyses

Clinical Practice Guidelines