Product Details

Auro-Repaglinide

Repaglinide
0.5 mg
Tablet


DIN/PIN/NPN

02424258

Manufacturer

Auro Pharma Inc.

Formulary Listing Date

2015-01-28  

Unit Price

0.2083

Amount MOH Pays

0.2083

Coverage Status

Off-Formulary Interchangeable Exceptional Access Program Product

ODB Formulary Therapeutic Classification

Therapeutic Note

NO

ATC Code

A10BX02

Interchangeable Products

DIN/ PIN/ NPN Brand name Unit Price Amount MOH pays
02357453 Sandoz Repaglinide 0.2083 0.2083
02354926 Jamp Repaglinide 0.2083 0.2083
02239924 GlucoNorm NA NA
02321475 Co Repaglinide 0.2083 0.2083
02424258 Auro-Repaglinide 0.2083 0.2083
02355663 Apo-Repaglinide 0.2083 0.2083
 

LU Clinical Criteria

NO  

EAP Criteria

Therapeutic Class Reimbursement Criteria
Antidiabetic Agents

Repaglinide

  • Brand(s): GlucoNorm
  • Dosage Form/Strength: 0.5 mg, 1 mg, 2 mg tablet

For the treatment of type 2 diabetes in patients with:

  1. Inadequate glycemic control (HbA1c >7%) using maximal* doses of a sulfonylurea AND metformin (2000mg/day) OR

  2. Inadequate glycemic control and demonstrated intolerance or contraindication to metformin and who are on maximal* doses of a sulfonylurea OR

  3. Inadequate glycemic control and demonstrated intolerance or contraindication to a sulfonylurea (glyburide, gliclazide or glimepiride) and are on maximal** doses of metformin OR

  4. Demonstrated intolerance or contraindication to both a sulfonylurea (glyburide, gliclazide or glimepiride) AND metformin OR

  5. Adequate glycemic control (HbA1c ≤ 7%) who develops intolerance or contraindication to sulfonylurea (glyburide, gliclazide or glimepiride) or metformin OR

  6. HbA1c ≤ 7% but with greater than 50% of fasting blood glucose (FBG >7mmol/L) or post-prandial plasma glucose (PPG >10mmol/L) levels not within target range and using maximally tolerated doses of a sulfonylurea and metformin.

*Note: For the purpose of the EAP submission, maximal dose of sulfonylurea is considered to be glyburide 10mg/day, gliclazide 160 mg/day or Diamicron MR 60 mg/day, OR glimepiride (Amaryl) 4 mg/day.

**Note: For the purpose of the EAP submission, maximal dose of metformin is considered to be 2000 mg/day

Duration of Approval: 5 years

EAP Drug Request Form:

Standard Form for EAP Drug Requests

Product Monograph

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