From the FDA Drug Label
1 INDICATIONS AND USAGE 1.1 Clostridioides difficile-Associated Diarrhea DIFICID® is indicated in adult and pediatric patients aged 6 months and older for the treatment of C. difficile-associated diarrhea (CDAD).
Treatment of C. difficile-associated diarrhea (CDAD): Fidaxomicin (DIFICID) is indicated for the treatment of CDAD in adult and pediatric patients aged 6 months and older 1.
- Key points:
- Fidaxomicin is used to treat CDAD.
- It is indicated for adults and pediatric patients aged 6 months and older.
From the Research
For the treatment of Clostridioides difficile infection, fidaxomicin is a recommended option, particularly for patients with recurrent or severe infections, as it has been shown to be effective in reducing recurrence and improving clinical outcomes, as demonstrated in a recent case report where extended-pulsed fidaxomicin therapy was successful in treating a patient with multiple recurrences 2.
Treatment Options
- Oral vancomycin 125 mg four times daily for 10 days is a commonly recommended treatment for initial episodes of C. diff infection.
- Fidaxomicin 200 mg twice daily for 10 days is also recommended, particularly for patients with recurrent or severe infections.
- Metronidazole 500 mg three times daily for 10 days can be used for non-severe cases.
Recurrent Infections
- Recurrent infections occur in about 20% of cases and may require extended vancomycin tapers, fidaxomicin, or fecal microbiota transplantation.
- A study comparing fidaxomicin, metronidazole, and vancomycin for initial episode and recurrence of C. diff infection found that fidaxomicin had increased odds of suffering another episode of C. diff, and was inferior to metronidazole for recurrent C. diff infection 3.
Prevention
- Prevention includes proper hand hygiene with soap and water, contact precautions for infected patients, and antimicrobial stewardship to limit unnecessary antibiotic use.
- A study comparing fidaxomicin with oral vancomycin for the treatment of C. diff infection in hospitalized patients receiving concomitant antibiotics found that fidaxomicin had a numerically higher proportion of clinical cure, but this result did not reach statistical significance 4.
Special Considerations
- Patients with inflammatory bowel disease may require special consideration, as a study found that fidaxomicin led to resolution of C. diff infection in 60.6% of patients, with 30.0% developing a recurrence 5.
- Another study found that fidaxomicin was superior to metronidazole, vancomycin, or their combination for a sustained clinical response and in the prevention of recurrent C. diff infection in the initial episode, first recurrence, and non-severe cases 6.