Drug updated on 9/4/2024
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
- Dificid (fidaxomicin) is indicated for the treatment of C. difficile-associated diarrhea in adult and pediatric patients 6 months of age and older.
- This summary is based on the review of 11 systematic review(s)/meta-analysis(es). [1-11]
- Fidaxomicin (FDX) showed significantly higher global cure rates compared to vancomycin (VCM) (RR = 1.18, P < 0.00001).
- Clinical cure rates were comparable between FDX and VCM (P = 0.31), while FDX had significantly lower recurrence rates than VCM (RR = 0.59, P < 0.0001).
- FDX demonstrated superior sustained cure rates compared to VCM (OR: 1.61; 95% CrI: 1.27, 2.05) and metronidazole (MTZ) (OR: 2.39; 95% CrI: 1.65, 3.47).
- No significant differences in all-cause mortality or adverse event rates were observed between FDX and VCM, though FDX showed a lower recurrence rate and higher global cure rate compared to VCM and MTZ.
- Adverse event rates were not significantly different between fidaxomicin (FDX) and vancomycin (VCM) (P = 0.41).
- No significant safety concerns or specific adverse effects were highlighted in the reviewed studies.
- The majority of studies focused on adult patients aged 46 to 75 years with primary or recurrent Clostridioides difficile infection (CDI), with specific considerations for patients with inflammatory bowel disease (IBD), where fidaxomicin or vancomycin was recommended for initial CDI episodes and fecal microbiota transplantation for recurrent cases.
Product Monograph / Prescribing Information
Document Title | Year | Source |
---|---|---|
Dificid (fidaxomicin) Prescribing Information. | 2022 | Merck & Co., Inc., Rahway, NJ |