Product Details

Auro-Sunitinib

Sunitinib Malate
12.5 mg
Capsule


DIN/PIN/NPN

02532190

Manufacturer

Auro Pharma Inc.

Formulary Listing Date

2023-08-31  

Unit Price

55.3553

Amount MOH Pays

55.3553

Coverage Status

Off-Formulary Interchangeable Exceptional Access Program Product

ODB Formulary Therapeutic Classification

Therapeutic Note

NO

ATC Code

L01EX01

Interchangeable Products

DIN/ PIN/ NPN Brand name Unit Price Amount MOH pays
02280795 Sutent 65.1240 55.3553
02524058 Taro-Sunitinib 55.3553 55.3553
02532840 Sandoz Sunitinib 55.3553 55.3553
02532190 Auro-Sunitinib 55.3553 55.3553
02526204 Teva-Sunitinib 55.3553 55.3553
 

LU Clinical Criteria

NO  

EAP Criteria

Therapeutic Class Reimbursement Criteria
Oncology Drugs

Sunitinib

  • Brand(s): Sutent and generics
  • Dosage Form/Strength: 12.5 mg, 25 mg, 50 mg capsule

For the treatment of gastrointestinal stromal tumour (GIST) in patients with unresectable or metastatic/recurrent GIST where one of the following conditions is met:

  1. Early progression (within 6 months) while on imatinib; OR

  2. Progression following treatment with optimum (escalated) doses of imatinib (800mg per day); OR

  3. Intolerance* to imatinib (where detailed description of intolerance is provided).

*Definition of intolerance to imatinib – patient has experienced persistent grade 3 toxicity requiring discontinuation of therapy.

Duration of Approval: 6 months

Renewal will be considered for patients who are stable (no disease progression) and not experiencing intolerance to sunitinib therapy.

Note: Approval will be granted at a dose of 50mg per day (4 weeks on, 2 weeks off).

For the treatment of metastatic renal cell carcinoma (MRCC):

  1. First-line therapy for patients with MSK Prognostic Score of Favourable Risk or an Intermediate Risk OR

  2. Second-line therapy for patients where:
    • The disease is of clear cell histology AND
    •     Documented failure to first-line cytokine-based therapy

Duration of Approval: 1 year

Renewal will be considered for patients with documentation of radiography and/or scan results indicating no diseases progression.

Duration of Approval: 1 year

Note: The prescribed dosage should be 50 mg daily for four (4) weeks, followed by two (2) weeks off the Drug Product, in repeated six (6) week cycles.

For the treatment of progressive, unresectable, well-differentiated or moderately differentiated, locally advanced or metastatic pancreatic neuroendocrine tumors (“pNET”) with good performance status (ECOG ≤ 2), until disease progression.

Exclusion criteria: Sutent will not be approved for second-line sequential therapy after everolimus failure in the first-line setting.

Dosing: 37.5 mg daily

EAP Drug Request Form:

Standard Form for EAP Drug Requests

Product Monograph

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