Product Details

Aranesp

Darbepoetin alfa
300 mcg/0.6 mL (500 mcg/mL)
Solution for Injection
SingleJect 0.6-mL Prefilled Syringe (Preservative-Free)

DIN/PIN/NPN

02391821

Manufacturer

Amgen Canada Inc.

Formulary Listing Date

2014-01-30  

Unit Price

1082.9500

Amount MOH Pays

1082.9500

Coverage Status

Limited Use Product

ODB Formulary Therapeutic Classification

Therapeutic Note

NO

ATC Code

B03XA02

Interchangeable Products

NO  

LU Clinical Criteria

LU Code Auth. Period Clinical Criteria
420 1 year

ESAs (Eprex or Aranesp) for patients with:

-Cancer diagnosis and receiving chemotherapy; AND
-Presence of anemia caused by chemotherapy with a hemoglobin count less than 100g/L; AND
-Patient has been informed of the risks and benefits of ESA therapy 

AND

Anemia cannot be managed by use of blood transfusions due to at least one of the following:

-Religious beliefs do not allow the patient to receive transfusions.
-Previous severe (potentially life-threatening) reaction to a transfusion or difficulty cross-matching.
-Myeloid cancers that cannot be managed with blood transfusions
-Patient lives far away from treatment centre and/or transfusions cannot be coordinated with chemotherapy
-Patients receiving neoadjuvant chemotherapy with anemia and at risk of high blood losses due to surgery

Please refer to the product monograph for starting dose, dose adjustment and discontinuation recommendations.

Note: Health Canada has issued the following statements regarding ESA therapy for the treatment of anemia due to chemotherapy in patients with non-myeloid malignancies:

In patients with a long-life expectancy, the decision to administer ESAs should be based on a benefit-risk assessment with the participation of the individual patient. This should take into account the specific clinical context such as (but not limited to) the type of tumor and its stage, the degree of anemia, life expectancy, the environment in which the patient is being treated and known risks of transfusions and ESAs.

If appropriate, red blood cell transfusion should be the preferred treatment for the management of anemia in patients with a long-life expectancy and who are receiving myelosuppressive chemotherapy.

ESAs are not indicated for use in patients receiving hormonal agents, therapeutic biologic products, or radiotherapy unless receiving concomitant myelosuppressive chemotherapy.

Health Canada has also issued the following Serious Warnings and Precautions for cancer patients regarding ESAs:

- ESAs increased the risks for death and serious cardiovascular and thromboembolic events in some controlled clinical trials.

- ESAs shortened overall survival and/or increased the risk of tumour progression or recurrence in some clinical studies in patients with breast, head and neck, lymphoid, cervical and non-small cell lung cancers when dosed to target a hemoglobin of greater than or equal to 120g/L.

To minimize the above risks, use the lowest dose needed to avoid red blood cell (RBC) transfusions.

Use ESAs only for treatment of anemia due to concomitant myelosuppressive chemotherapy.

If appropriate, red blood cell transfusion should be the preferred treatment for the management of anemia in patients with a long-life expectancy and who are receiving myelosuppressive chemotherapy.

Discontinue ESAs following completion of a chemotherapy course.
 

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

View Monograph