Limited Use Note(s)

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EPOETIN ALFA10,000IU/mL Pref Syr - 1mL Pk
Reason For Use CodeClinical Criteria
420ESAs (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.
LU Authorization Period: 1 year