Product Details

Renvela

Sevelamer Carbonate
0.8 g/Sachet
Powder for Oral Suspension


DIN/PIN/NPN

02485559

Manufacturer

Sanofi-Aventis Canada Inc.

Formulary Listing Date

2021-06-07  

Unit Price

1.2634

Amount MOH Pays

1.2634

Coverage Status

Exceptional Access Program Product

ODB Formulary Therapeutic Classification

Therapeutic Note

NO

ATC Code

V03AE02

Interchangeable Products

NO  

LU Clinical Criteria

NO  

EAP Criteria

Therapeutic Class Reimbursement Criteria
Chronic Renal Failure Drugs – Telephone Request Service (TRS) Drugs

Lanthanum

  • Brand(s): Fosrenol and Generics
  • Dosage Form/Strength: 250 mg, 500 mg, 750 mg, 1000 mg Chewable tablet

Sevelamer Hydrochloride

  • Brand(s): Renagel
  • Dosage Form/Strength: 800 mg tablet

Sevelamer Carbonate

  • Brand(s): Accel-Sevelamer
  • Dosage Form/Strength: 800 mg tablet

  • Brand(s): Renvela
  • Dosage Form/Strength: 800 mg tablet, 0.8 g powder sachet, 2.4 g powder sachet

Updated: June 7, 2021

  1. For the treatment of hyperphosphatemia associated with end-stage renal disease (ESRD) where patients are on dialysis and have a sustained serum phosphate > 1.8 mmol/L AND adjusted serum calcium > 2.65 mmol/L;

    OR

  1. For dialysis patients experiencing hyperphosphatemia (sustained serum phosphate levels >1.8 mmol/L) who have calciphylaxis and/or evidence of coronary artery calcification.

Notes:

  1. Calcium and phosphate levels provided to demonstrate sustained elevations should be at least 4 weeks apart.

  1. Patients who demonstrate reduction of phosphate levels while on a calcium binder but who experience adjusted serum calcium > 2.65 mmol/L must provide supporting laboratory levels before treatment and while on treatment and should include the dose(s) of calcium-based binder used.

Exclusion Criteria: 

Sevelamer will not be reimbursed in the following cases: 

  • Use in combination therapy with another funded non-calcium-based phosphate binder (e.g., lanthanum carbonate hydrate, sucroferric oxyhydroxide, other sevelamer formulations)

Duration of approval: lifetime 

On a case-by-case basis, requests may be considered for sevelamer under the EAP for a patient with serum phosphate less than 1.8mmol/L and calcium values less than 2.65 mmol/L.

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