Product Details

Aranesp

Darbepoetin alfa
10 mcg/0.4 mL (25 mcg/mL)
Solution for Injection
SingleJect 0.4-mL Prefilled Syringe (Preservative-Free)

DIN/PIN/NPN

02392313

Manufacturer

Amgen Canada Inc.

Formulary Listing Date

0000-00-00  

Unit Price

Amount MOH Pays

Coverage Status

Exceptional Access Program Product

ODB Formulary Therapeutic Classification

Therapeutic Note

NO

ATC Code

B03XA02

Interchangeable Products

NO  

LU Clinical Criteria

NO  

EAP Criteria

Therapeutic Class Reimbursement Criteria
Anemia

Darbepoetin

  • Brand(s): Aranesp
  • Dosage Form/Strength: Prefilled syringes: 150 mcg, 200 mcg, 300 mcg, 500 mcg

(Requests for the treatment of chemotherapy-induced anemia in patients with malignant cancer DO NOT require an EAP submission. Please refer to the ODB e-formulary to determine if the patient satisfies the criteria for use.)

For the treatment of anemia secondary to chronic renal disease in those who are not eligible under the Special Drugs Program, approval can be given if the patient meets the following criteria:

  • Estimated glomerular filtration rate (GFR) less than 30 mL/min AND
  • Baseline hemoglobin level less than 100 g/L AND
  • Mean corpuscular volume (MCV) level between 75 fL and 120 fL

All requests MUST indicate the reason why the patient is ineligible for the Special Drugs Program.

Duration of Approval: 6 months

Renewals will be provided to patients where the hemoglobin levels have improved by 15 g/L after 3 months of therapy.

Renewals must specify the name of the drug and dose requested and MUST be accompanied by bloodwork that includes a recent hemoglobin level. Also, please identify if the patient has received transfusions after the first 2 weeks of therapy with darbepoetin and the date (s) that the transfusion(s) occurred.

Duration of Approval: 12 months

For the treatment of anemia secondary to myelodysplastic syndrome (MDS) in patients who meet the following criteria:

  • MDS confirmed by the bone marrow report AND

  • With a hemoglobin count less than 100 g/L AND

  • Endogenous erythropoietin level of less than 500 U/L AND

  • Mean corpuscular volume (MCV) level between 75 fL and 120 fL.

Submissions must include the date(s) for the above blood work.

For patients with an MCV level below 75 fL or above 120 fL, the physician must provide a discussion of how reversible causes of anemia were ruled out to enable further consideration of the submission.

Duration of Approval: 6 months

Renewals will be provided to patients where the hemoglobin levels have improved by 15 g/L after 3 months of therapy.

Renewals must specify the name of the drug and dose requested and MUST be accompanied by bloodwork that includes a recent hemoglobin level. Also, please identify if the patient has received transfusions after the first 2 weeks of therapy with darbepoetin and the date(s) that the transfusion(s) occurred.

Duration of Approval: 12 months

EAP Drug Request Form:

Standard Form for EAP Drug Requests

Product Monograph

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