Product Details

Auro-Sunitinib

Sunitinib Malate
50 mg
Capsule


DIN/PIN/NPN

02532220

Manufacturer

Auro Pharma Inc.

Formulary Listing Date

2023-08-31  

Unit Price

221.4208

Amount MOH Pays

221.4208

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
02280817 Sutent 260.4950 221.4208
02524082 Taro-Sunitinib 221.4208 221.4208
02532883 Sandoz Sunitinib 221.4208 221.4208
02532220 Auro-Sunitinib 221.4208 221.4208
02526220 Teva-Sunitinib 221.4208 221.4208
 

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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