Fidaxomicin

(Dificid®)

Fidaxomicin

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Drug updated on 4/10/2024

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.

Summary
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  • Fidaxomicin (Dificid) is indicated for the treatment of C. difficile-associated diarrhea in adult and pediatric patients 6 months of age and older.
  • Studies related to Dificid's use in treating Clostridioides difficile infection (CDI) include systematic reviews and meta-analyses.
  • Studies highlight fidaxomicin's superiority or comparability to vancomycin in achieving global and clinical cure rates for CDI with significantly lower recurrence rates.
  • Compared to metronidazole, fidaxomicin showed a significantly lower risk of initial treatment failure and symptomatic recurrence necessitating re-treatment.
  • No significant differences were observed in adverse event rates from fidaxomicin compared to vancomycin, indicating comparable safety profiles between these two treatment options.
  • Resistance against fidaxomicin was reported as exceedingly rare, offering an advantage over other treatments regarding long-term efficacy sustainability, potentially contributing towards better antibiotic stewardship.
  • For patients with Inflammatory Bowel Disease (IBD), fidaxomicin, alongside vancomycin, is recommended for the treatment of an initial episode of CDI, highlighting its importance in managing this particularly vulnerable subgroup.
  • Further research is encouraged on real-world evidence suggesting potential preference for using fidaxomicin instead of vancomycin across various clinical scenarios, including specific subpopulations.

Product Monograph / Prescribing Information

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

Systematic Reviews / Meta-Analyses

Document TitleYearSource
Clostridioides difficile Infection in Inflammatory Bowel Disease Patients: A Systematic Review of Risk Factors and Approach in Management.2023Cureus
The effect of antibiotic therapy for Clostridioides difficile infection on mortality and other patient-relevant outcomes: A systematic review and meta-analysis.2023Clinical Microbiology and Infection
Oral fidaxomicin versus vancomycin for the treatment of Clostridioides difficile infection: A systematic review and meta-analysis of randomized controlled trials.2022Journal of Infection and Chemotherapy
Real-world comparison of fidaxomicin versus vancomycin or metronidazole in the treatment of Clostridium difficile infection: A systematic review and meta-analysis.2022European Journal of Clinical Pharmacology
Path of least recurrence: A systematic review and meta-analysis of fidaxomicin versus vancomycin for Clostridioides difficile infection.2022Pharmacotherpay
Fidaxomicin compared with vancomycin and metronidazole for the treatment of Clostridioides (Clostridium) difficile infection: A network meta-analysis2020Journal of Infection and Chemotherapy
Prevention of recurrent Clostridioides difficile infection: a systematic review of randomized controlled trials.2020Anaerobe
Antimicrobial resistance in Clostridioides (Clostridium) difficile derived from humans: a systematic review and meta-analysis.2020Antimicrobial Resistance and Infection Control
A network meta-analysis of randomized controlled trials exploring the role of fecal microbiota transplantation in recurrent Clostridium difficile infection.2019United European Gastroenterology
Increasing antibiotic resistance in Clostridioides difficile: A systematic review and meta-analysis2019Information Infection Control & Hospital Epidemiology
The prevalence of antibiotic-resistant Clostridium species in Iran: a meta-analysis2019Pathogens and Global Health

Clinical Practice Guidelines

Document TitleYearSource
Clostridioides difficile infection: antimicrobial prescribing. 2021NICE
European Society of Clinical Microbiology and Infectious Diseases: 2021 update on the treatment guidance document for Clostridioides difficile infection in adults.2021Clinical Microbiology and Infection
Clinical practice guideline by the Infectious Diseases Society of America (IDSA) and Society for Healthcare Epidemiology of America (SHEA): 2021 focused update guidelines on management of Clostridioides difficile infection in adults.2021Clinical Infectious Diseases
Clinical Guideline Highlights for the Hospitalist: Diagnosis and Management of Clostridium difficile in Adults2020Journal of Hospital Medicine
Guidelines for Clostridium difficile infection in adults.2020PrzeglÄ…d Gastroenterologiczny
Treatment of Clostridioides (Clostridium) difficile infection2020Annals of Medicine
Recommendations for the diagnosis and treatment of Clostridioides difficile infection: An official clinical practice guideline of the Spanish Society of Chemotherapy (SEQ), Spanish Society of Internal Medicine (SEMI) and the working group of Postoperative Infection of the Spanish Society of Anesthesia and Reanimation (SEDAR).2020Revista Espanola de Quimioterapia
2019 update of the WSES guidelines for management of Clostridioides (Clostridium) difficile infection in surgical patients.2019World Journal of Emergency Surgery
Interventions for the Treatment and Management of Clostridioides Difficile: Clinical Effectiveness and Guidelines.2019CADTH