FIDAXOMICIN TAB
Clinical Criteria Summary
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Exclusion Criteria
- Prescribed for the treatment of systemic infections
- History of hypersensitivity reaction to fidaxomicin or another macrolide antibiotic
- Asymptomatic Clostridioides difficile colonization
- Fulminant Clostridioides difficile infection (CDI) (e.g., life-threatening CDI or toxic megacolon) or ileus
Inclusion Criteria
- Clinical symptom onset (e.g., 3 or more unformed stools in 24 hours after discontinuation of laxatives) AND laboratory confirmation of CDI
- PLUS at least one of the following:
- Initial episode of CDI who is at increased risk of CDI recurrence (age ≥65 years old, concomitant antibiotic use during CDI treatment, and/or immunosuppression)
- Recurrent episode of CDI
Dosage and Administration
- Standard regimen: 200 mg orally twice daily for 10 days with or without food
- Extended-pulse regimen: 200 mg orally twice daily for 5 days, then 200 mg orally every other day for 20 days with or without food
Supplemental Clinical Information & Management Guidelines
- Recurrence is typically defined as a repeated symptomatic, laboratory-confirmed case of CDI within 12 weeks after a prior episode
- Patients at high risk of CDI recurrence include age ≥65 years old, concomitant antibiotic use during CDI treatment, and immunosuppression
- Vancomycin 125 mg PO QID x 10 days is an acceptable alternative treatment regimen for a first episode of CDI
- A repeat standard course of vancomycin or a tapered and pulse vancomycin regimen are acceptable alternative options for the first recurrent episode of CDI (vancomycin taper/pulsed regimen is also acceptable for subsequent recurrences)
- Infectious Diseases and/or Gastroenterology consults should be considered for patients with multiple CDI recurrences or fulminant CDI
- Discontinue therapy with the inciting antimicrobial as soon as possible, as this may influence the risk of CDI recurrence
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Indications & Clinical Use
- • Treatment of initial and recurrent non-fulminant Clostridioides difficile infection (CDI)
- • First-line treatment option for initial, recurrent, non-severe, and severe, non-fulminant CDI episodes
- • Appropriate choice for first recurrence in patients initially treated with vancomycin who experience recurrence
Dosing & Regimens
- • Standard regimen: 200 mg by mouth twice daily (BID) for 10 days
- • Extended-pulse regimen: 200 mg BID for 5 days followed by one tablet every other day (QOD) on days 7–25
Contraindications & Exclusions
- • History of hypersensitivity reaction to fidaxomicin or another macrolide antibiotic
- • Systemic infections
- • Asymptomatic C. difficile colonization
- • Fulminant CDI or patients with ileus
Guideline Recommendations & Formulary Criteria
- • Preferred first-line agent per IDSA/SHEA guidelines, particularly for patients at high risk of recurrence
- • Recommended as an alternative to vancomycin after an initial course of vancomycin or metronidazole for first recurrence
- • Standard or extended-pulse regimen recommended for second or subsequent recurrences (per IDSA/SHEA; ACG guidelines do not specifically recommend fidaxomicin for subsequent recurrences)
- • Updated VA Criteria For Use aligns with 2021 guidelines to broaden the role of fidaxomicin as a treatment option for CDI and address prior underutilization in the VA system