VFEND (voriconazole)

VFEND (voriconazole)

SELF ADMINISTRATION - Oral

OFFICE ADMINISTRATION - IV injection

Indications for Prior Authorization:

• Treatment of Invasive aspergillosis, including disseminated and extrapulmonary infection.  In clinical trials, the majority of isolates recovered were Aspergillus fumigatus. There were a small number of cases of culture-proven disease due to species of Aspergillus other than A. fumigatus.
• Candidemia in non-neutropenic patients and the following Candida infections: disseminated infections in skin and infections in abdomen, kidney, bladder wall, and wounds.
• Esophageal candidiasis.
• Scedosporiosis, fusariosis:  Serious fungal infections caused by Scedosporium apiospermum (asexual form of Pseudallescheria boydii) and Fusarium spp. including Fusarium solani, in patients intolerant of, or refractory to, other therapy.

Patients must meet the following criteria for the indication(s) above:

• Prescribed by or in collaboration with an infectious disease specialist, AND
• Patient is 2 years of age or older, AND
• Patient is being treated for invasive aspergillosis infection OR salvage therapy (failure, intolerance or contraindications of other therapies) to treat a fungal infection caused by Fusarium or Scedosporium species, OR
•  Patient has been diagnosed with candidemia, esophageal candidiasis, a disseminated (widespread) Candida infection in the skin, or a Candida infection in the abdomen, kidney, bladder wall, or wounds, AND
• The patient has experienced an inadequate treatment response, intolerance, or contraindication to fluconazole or itraconazole (e.g., fluconazole or itraconazole-resistant, voriconazole-susceptible infection).

Dosing:

Aspergillosis, invasive, including disseminated and extrapulmonary infection; treatment:

• IV:  
  • Initial: 6 mg/kg every 12 hours for 2 doses
  • Maintenance dose: 4 mg/kg every 12 hours
• Oral:
  • Maintenance dose:  
    • Manufacturer's labeling: Note: If patient has inadequate clinical response, titrate in 50 mg/dose increments for weight < 40 kg and 100 mg/dose increments for weight ≥ 40 kg.
      • Weight < 40 kg: 100 mg every 12 hours
      • Weight ≥ 40 kg: 200 mg every 12 hours
    • Alternate recommendations: Note: In patients able to tolerate oral administration, may consider oral in place of IV; however, IV administration is recommended in seriously ill patients 
      • Oral: 200 to 300 mg every 12 hours or weight-based dosing (3 to 4 mg/kg) every 12 hours.
• Duration of therapy: Minimum of 6 to 12 weeks, although duration is highly dependent on degree/duration of immunosuppression, disease site, and evidence of disease improvement

Candidemia in non-neutropenic patients and disseminated Candida infections in skin, and infections in abdomen, kidney, bladder wall and wounds: Treatment should continue for a minimum of 14 days following resolution of symptoms or following last positive culture, whichever is longer.

• IV:  
  • Initial: 6 mg/kg every 12 hours for 2 doses
  • Maintenance: 3 to 4 mg/kg every 12 hours
• Oral:  
  • Maintenance dose:
    • Manufacturer's labeling: Note: If patient has inadequate clinical response, titrate in 50 mg/dose increments for weight < 40 kg and 100 mg/dose increments for weight ≥ 40 kg
      • Weight < 40 kg: 100 mg every 12 hours
      • Weight ≥ 40 kg: 200 mg every 12 hours
    • Alternate recommendations: Candidemia in non-neutropenic patients:
      • Initial therapy: 400 mg (6 mg/kg) IV every 12 hours for 2 doses, followed by 200 mg (3 mg/kg) IV or orally every 12 hours. Note: Voriconazole is considered alternative therapy and offers little advantage over fluconazole as first-line therapy of candidemia.
      • Step-down therapy (after patient has responded to initial therapy):
        • Oral: 
          • Isolates of C. glabrata (voriconazole-susceptible isolates): 200 to 300 mg (3 to 4 mg/kg) twice daily
          • Isolates of C. krusei (selected cases): 200 mg every 12 hours
        • Duration: Continue for 14 days after first negative blood culture and resolution of signs/symptoms; step-down therapy to voriconazole (eg, after 5 to 7 days in nonneutropenic patients) is recommended only in select clinically stable patients with certain voriconazole-susceptible isolates and negative repeat cultures.

Candidiasis, esophageal:

• Manufacturer's labeling:
  • Oral: Treatment should continue for a minimum of 14 days, and for at least 7 days following resolution of symptoms. Note: If patient has inadequate clinical response, titrate in 50 mg/dose increments for weight < 40 kg and 100 mg/dose increments for weight ≥ 40 kg
    • Weight < 40 kg: 100 mg every 12 hours; maximum: 300 mg daily
    • Weight ≥ 40 kg: 200 mg every 12 hours; maximum: 600 mg daily
• Alternative dosing:
  • Fluconazole-refractory: Oral, IV (off-label route): 200 mg (3 mg/kg) twice daily for 14 to 21 days 
  • HIV-positive patients (alternative to preferred therapy): Oral, IV (off-label route): 200 mg twice daily for 14 to 21 days

Scedosporiosis, Fusariosis:

• IV:  
  • Initial: 6 mg/kg every 12 hours for 2 doses
  • Maintenance dose: 4 mg/kg every 12 hours for >7 days
• Oral:
  • Maintenance dose: Note: If patient has inadequate clinical response, titrate in 50 mg/dose increments for weight < 40 kg and 100 mg/dose increments for weight ≥ 40 kg.
    • Weight < 40 kg: 100 mg every 12 hours.
    • Weight ≥ 40 kg: 200 mg every 12 hours.

Approval:  

• Up to 12 weeks.  
• Renewal consideration requires chart notes and current lab results and evidence based support dependent on diagnosis.