Product Details

Cresemba

Isavuconazole
200 mg/Vial
Powder for Solution for Injection
Vial Pack (Preservative-Free)

DIN/PIN/NPN

02483998

Manufacturer

Avir Pharma Inc.

Formulary Listing Date

2020-03-04  

Unit Price

400.0000

Amount MOH Pays

400.0000

Coverage Status

Exceptional Access Program Product

ODB Formulary Therapeutic Classification

Therapeutic Note

NO

ATC Code

J02AC05

Interchangeable Products

NO  

LU Clinical Criteria

NO  

EAP Criteria

Therapeutic Class Reimbursement Criteria
Anti-Infectives

Isavuconazole

  • Brand(s): Cresemba
  • Dosage Form/Strength: 100 mg capsule, 200 mg Injection Solution

NOTE: Prescribers must submit the laboratory results to confirm the patient's infection and include drugs and drug regimens that have been used for the patient's condition, including the response to prior therapies and other relevant clinical information. Please also confirm that the patient does not meet the exclusion criteria.

For the treatment of invasive aspergillosis in patients meeting the following criteria:

  1. 18 years of age and older; AND 

  2. Patient has failed, experienced intolerance to, or has contraindications to voriconazole; AND

  3. Isavuconazole is prescribed by or in consultation with an infectious disease specialist. (Include consult note with the request) 

Exclusion criteria:
Patients with familial short QT syndrome. 

Approval Duration: 3 months 

Renewals will be considered on a case-by-case basis.

For the treatment of invasive mucormycosis in patients meeting the following criteria:

  1. 18 years of age and older; AND

  2. Isavuconazole is prescribed by or in consultation with an infectious disease specialist. (Include consult note with the request) 

Exclusion criteria:
Patients with familial short QT syndrome.

Approval Duration: 3 months 

Renewals will be considered on a case-by-case basis 

Recommended dose:
- 200mg administered intravenously or orally every 8 hours for 6 doses followed by a maintenance dose of 200mg daily starting 12 to 24 hours after the last loading dose.

Oral therapy should be considered as a preferred option when clinically appropriate. A loading dose is not required when switching from intravenous to oral treatment or vice versa.

EAP Drug Request Form:

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

Isavuconazole

  • Brand(s): Cresemba
  • Dosage Form/Strength: 100 mg capsule, 200 mg Injection Solution

NOTE: Prescribers must submit the laboratory results to confirm the patient's infection and include drugs and drug regimens that have been used for the patient's condition, including the response to prior therapies and other relevant clinical information. Please also confirm that the patient does not meet the exclusion criteria.

For the treatment of invasive aspergillosis in patients meeting the following criteria:

  1. 18 years of age and older; AND 

  2. Patient has failed, experienced intolerance to, or has contraindications to voriconazole; AND 

  3. Isavuconazole is prescribed by or in consultation with an infectious disease specialist. (Include consult note with the request) 

Exclusion criteria:
Patients with familial short QT syndrome. 

Approval Duration: 3 months 

Renewals will be considered on a case-by-case basis.

For the treatment of invasive mucormycosis in patients meeting the following criteria:

  1. 18 years of age and older; AND 

  2. Isavuconazole is prescribed by or in consultation with an infectious disease specialist. (Include consult note with the request) 

Exclusion criteria:
Patients with familial short QT syndrome.

Approval Duration: 3 months 

Renewals will be considered on a case-by-case basis 

Recommended dose:
- 200mg administered intravenously or orally every 8 hours for 6 doses followed by a maintenance dose of 200mg daily starting 12 to 24 hours after the last loading dose. 

Oral therapy should be considered as a preferred option when clinically appropriate. A loading dose is not required when switching from intravenous to oral treatment or vice versa.

Product Monograph

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