Drug updated on 7/25/2024
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.
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Summary
- Fidaxomicin (Dificid) is indicated for the treatment of C. difficile-associated diarrhea in adult and pediatric patients 6 months of age and older.
- A total of 11 systematic reviews/meta-analyses were reviewed to gather information about fidaxomicin’s effectiveness and safety compared to other treatments for Clostridioides difficile infection (CDI).
- Both vancomycin and fidaxomicin are common treatments for an initial episode of CDI, especially in patients with inflammatory bowel disease (IBD), but fecal microbiota transplantation is recommended for recurrent CDI.
- Fidaxomicin has lower recurrence rates than vancomycin, although both drugs show no significant difference in all-cause mortality; clinical cure rates are comparable between them.
- Real-world studies indicate that while there was a higher risk of treatment failure with fidaxomicin, it did not significantly differ from vancomycin or metronidazole regarding clinical cure, sustained cure, recurrence rate, or all-cause mortality.
- Recurrence rates are consistently lower with fidaxomicin across various subgroups including initial CDI cases, first recurrent cases, non-severe/severe cases, as well as inpatient/outpatient settings, validating its preference over vancomycin per guidelines.
- Network meta-analysis shows that while clinical cure rates between fidaxomicin and vancomycin do not differ significantly, fidaxomicin excels at preventing recurrences when compared to both metronidazole and vancomycin, making it superior particularly against mild/moderate CDIs.
- Resistance patterns reveal rare resistance development towards fidaxomicin, whereas increasing trends have been observed among other antibiotics like vancomycin and metronidazole, thus positioning fidaxomicin favorably amidst rising antibiotic resistances globally.
Product Monograph / Prescribing Information
Document Title | Year | Source |
---|---|---|
Dificid (fidaxomicin) Prescribing Information. | 2022 | Merck & Co., Inc., Rahway, NJ |