Limited Coverage Drugs - Fidaxomicin

Generic Name / Strength / Form

fidaxomicin / 200 mg / tablet

Special Authority Criteria

Approval Period

For the treatment of confirmed severe Clostridium Difficile Infection (CDI)i:

  1. As determined and when prescribed by an infectious disease specialist or gastroenterologist

    AND

    1. If there is a documented allergy (immune-mediated reaction) or severe intolerance to oral vancomycin resulting in discontinuation of vancomycin

      OR
       
    2. After an unsuccessful but adequate trial of oral vancomycinii AND when retreatment with vancomycin is not an option AND when the patient is at high risk of hospitalization due to severe life-threatening complications.

Notes:

  1. Severe infection is defined as having any of the following symptoms:
    • white blood cell count > 15,000 mm3 and fever
    • acute kidney injury with rising serum creatinine ≥ 1.5 times premorbid level or ≥ 175 micromole/litre
    • Pseudomembranous colitis, hypotension, shock, or megacolon.
  2. An adequate trial of oral vancomycin is considered to be at least 10 days of therapy with a dose of at least 125 mg four times a day.
 Up to 10 days for a single treatment course

Practitioner Exemptions

  • None

Special Notes

  • Fidaxomicin should be used as monotherapy (i.e., not as an add-on).
  • Requests for fidaxomicin in recurrent CDI will be considered in symptomatic patients that require treatment of a previously resolved CDI episode. This is defined as a subsequent CDI episode occurring within 2-8 weeks of a previous episode from the date of diagnosis.

Special Authority Request Form(s)