Drug updated on 4/10/2024
| Dosage Form | Tablet (oral; 200 mg); Suspension (oral; 40 mg/mL) |
| Drug Class | Macrolide 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
- 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 Title | Year | Source |
|---|---|---|
| Dificid (fidaxomicin) Prescribing Information. | 2022 | Merck & Co., Inc., Rahway, NJ |