Product Details

Dificid

Fidaxomicin
200 mg
Tablet


DIN/PIN/NPN

02387174

Manufacturer

Merck Canada Inc.

Formulary Listing Date

2016-01-28  

Unit Price

94.6000

Amount MOH Pays

94.6000

Coverage Status

Exceptional Access Program Product

ODB Formulary Therapeutic Classification

Therapeutic Note

NO

ATC Code

A07AA12

Interchangeable Products

NO  

LU Clinical Criteria

NO  

EAP Criteria

Therapeutic Class Reimbursement Criteria
Anti-Infectives

Fidaxomicin (May be accessed through the Telephone Request Service)

  • Brand(s): Dificid
  • Dosage Form/Strength: 200 mg tablet

For the treatment of Clostridium difficile infection (CDI) in patient who meet the EAP criteria for vancomycin use, but where the patient: 

  1. has experienced a third or subsequent episode within 6 months of treatment with vancomycin for prior episode(s), with no previous trial of fidaxomicin; OR 

  2. has experienced treatment failure* with oral vancomycin for the current CDI episode; OR 

  3. has had a documented allergy (immune‐mediated reaction) to oral vancomycin; OR

  4. has experienced a severe adverse reaction or intolerance** to oral vancomycin treatment that resulted in the discontinuation of vancomycin therapy. 

*Treatment failure is defined as 7 days of vancomycin therapy without acceptable clinical improvement.

**Details of severe adverse reaction or intolerance must be provided and should be clinically related to oral administration of vancomycin.

Re‐treatment criteria:

  • Re‐treatment with fidaxomicin will only be considered for an early relapse occurring within 30 days of the completion of the most recent fidaxomicin course. 

  • Relapse/recurrence occurring beyond 30 days after the completion of the most recent fidaxomicin course will require a trial with vancomycin, unless there is a documented allergy, severe adverse reaction or intolerance to prior oral vancomycin use.

Note: Fecal biotherapy (“stool transplantation”), if available, should be encouraged for this patient population. 

Approved dose and duration: 200 mg twice a day for 10 days

EAP Drug Request Form:

Standard Form for EAP Drug Requests
Anti-Infectives – Telephone Request Service (TRS) Drugs

Fidaxomicin

  • Brand(s): Dificid
  • Dosage Form/Strength: 200 mg tablet

For the treatment of Clostridium difficile infection (CDI) in patients who meet the EAP criteria for vancomycin use, but where the patient: 

  1. has experienced a third or subsequent episode within 6 months of treatment with vancomycin for prior episode(s), with no previous trial of fidaxomicin; OR 

  2. has experienced treatment failure* with oral vancomycin for the current CDI episode; OR 

  3. has had a documented allergy (immune‐mediated reaction) to oral vancomycin; OR

  4. has experienced a severe adverse reaction or intolerance** to oral vancomycin treatment that resulted in the discontinuation of vancomycin therapy. 

*Treatment failure is defined as 7 days of vancomycin therapy without acceptable clinical improvement. 

**Details of severe adverse reaction or intolerance must be provided and should be clinically related to oral administration of vancomycin. 

Re‐treatment criteria: 

  • Re‐treatment with fidaxomicin will only be considered for an early relapse occurring within 30 days of the completion of the most recent fidaxomicin course. 

  • Relapse/ recurrence occurring beyond 30 days after the completion of the most recent fidaxomicin course will require a trial with vancomycin, unless there is a documented allergy, severe adverse reaction or intolerance to prior oral vancomycin use. 

Note: Fecal biotherapy (“stool transplantation”), if available, should be encouraged for this patient population. 

Approved dose and duration: 200 mg twice a day for 10 days

Product Monograph

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