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Reason for Use code 420 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. Coverage limit: LU Authorization Period: 1 year Exceptional Access Program criteria on record (ministry list dated 2025-01-01, not exhaustive): Ministry criteria list dated January 1, 2025; the program's current criteria may differ; SADIE shows the current version. https://www.ontario.ca/page/sadie-special-authorization-digital-information-exchange 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. 19 Darbepoetin Brand(s): Aranesp DOSAGE FORM/ STRENGTH: Prefilled syringes:150 mcg, 200 mcg, 300 mcg, 500 mcg 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 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 20 EAP source: eap-frequently-requested-drugs-2025-01-01.txt, page 19, record 1, corpus 2025-01-01; name match only, not an eligibility decision

Turnaround times The Exceptional Access Program receives between 250 and 500 requests a day. Requests are categorized in order of priority based on how quickly a drug is needed, the type of drug, and the condition for which the drug is being used. Turnaround times begin on the business day on which the EAP receives a complete request from a physician or nurse practitioner. You may have to wait longer if the request is missing information or supporting documents required by the EAP criteria, if a request requires external review, or if documents are sent by fax or mail instead of submitted via SADIE. EAP Weekly Progress Report Date: September 15, 2026 Processing categories and examples | Target | Current | Priority 1 — for drugs such as antibiotics, cancer medications, and initial requests for pain medications | 3 business days | 2 business day | Priority 2 — for antiviral drugs to treat HIV, drugs for multiple sclerosis, and pulmonary hypertension | 5 business days | 3 business days | Biologics — for biologic drugs to treat rheumatoid arthritis, psoriatic arthritis, ulcerative colitis and Crohn’s disease | 10 business days | 4 business days | Chronic — for drugs used for chronic conditions such as migraines, chronic pain, Ménière's disease and symptoms of Parkinson’s disease. | 4 to 6 weeks | 11 business days | (ontario.ca, Updated September 15, 2026 ↗) For selected drugs, the Telephone Request Service is available to authorized prescribers or their delegates. In most cases, the funding decision is provided by the end of the call and processed within one business day. (ontario.ca, Updated September 15, 2026 ↗)

Aranesp · DIN 02391791 Manufacturer: Amgen Canada Inc.; listing date 2014-12-18 Health Canada: Marketed since 2014-04-21 · brand ARANESP · ATC B03XA02 DARBEPOETIN ALFA · form Solution · route Intravenous, Subcutaneous · ingredients DARBEPOETIN ALFA 500 MCG/ML · company Amgen canada inc · schedule Prescription, Schedule d

DIN 02391791: Aranesp Raw flags: sec12=Y, sec3=Y Item: 201600013; group id 266; item number 0535; lccId 00213; manufacturer id AMG Source form: Pref Syr-0.3mL Pk; strength: 150mcg/0.3mL Recorded listing: Limited Use: paid only with a Reason for Use code and the criteria below Source prices (unrounded): $402.0000; ministry $402.0000 Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02391791 Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=87711

Shortage status: no shortage or discontinuation reported (checked 2026-09-13T08:10:21.292534+00:00); reports as of 2026-09-13T08:10:21.292534+00:00 (Health Product Shortages Canada) Source: https://healthproductshortages.ca/search?term=02391791

Shortage record checked 2026-09-13T08:10:21.292534+00:00

Reason for Use code 420 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. Coverage limit: LU Authorization Period: 1 year Exceptional Access Program criteria on record (ministry list dated 2025-01-01, not exhaustive): Ministry criteria list dated January 1, 2025; the program's current criteria may differ; SADIE shows the current version. https://www.ontario.ca/page/sadie-special-authorization-digital-information-exchange 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. 19 Darbepoetin Brand(s): Aranesp DOSAGE FORM/ STRENGTH: Prefilled syringes:150 mcg, 200 mcg, 300 mcg, 500 mcg 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 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 20 EAP source: eap-frequently-requested-drugs-2025-01-01.txt, page 19, record 1, corpus 2025-01-01; name match only, not an eligibility decision

Turnaround times The Exceptional Access Program receives between 250 and 500 requests a day. Requests are categorized in order of priority based on how quickly a drug is needed, the type of drug, and the condition for which the drug is being used. Turnaround times begin on the business day on which the EAP receives a complete request from a physician or nurse practitioner. You may have to wait longer if the request is missing information or supporting documents required by the EAP criteria, if a request requires external review, or if documents are sent by fax or mail instead of submitted via SADIE. EAP Weekly Progress Report Date: September 15, 2026 Processing categories and examples | Target | Current | Priority 1 — for drugs such as antibiotics, cancer medications, and initial requests for pain medications | 3 business days | 2 business day | Priority 2 — for antiviral drugs to treat HIV, drugs for multiple sclerosis, and pulmonary hypertension | 5 business days | 3 business days | Biologics — for biologic drugs to treat rheumatoid arthritis, psoriatic arthritis, ulcerative colitis and Crohn’s disease | 10 business days | 4 business days | Chronic — for drugs used for chronic conditions such as migraines, chronic pain, Ménière's disease and symptoms of Parkinson’s disease. | 4 to 6 weeks | 11 business days | (ontario.ca, Updated September 15, 2026 ↗) For selected drugs, the Telephone Request Service is available to authorized prescribers or their delegates. In most cases, the funding decision is provided by the end of the call and processed within one business day. (ontario.ca, Updated September 15, 2026 ↗)

Aranesp · DIN 02391805 Manufacturer: Amgen Canada Inc.; listing date 2014-08-28 Health Canada: Marketed since 2014-05-05 · brand ARANESP · ATC B03XA02 DARBEPOETIN ALFA · form Solution · route Subcutaneous, Intravenous · ingredients DARBEPOETIN ALFA 500 MCG/ML · company Amgen canada inc · schedule Schedule d, Prescription

DIN 02391805: Aranesp Raw flags: sec12=Y, sec3=Y Item: 201600037; group id 266; item number 0536; lccId 00213; manufacturer id AMG Source form: Pref Syr-0.4mL Pk; strength: 200mcg/0.4mL Recorded listing: Limited Use: paid only with a Reason for Use code and the criteria below Source prices (unrounded): $701.0200; ministry $701.0200 Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02391805 Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=87712

Shortage status: no shortage or discontinuation reported (checked 2026-09-13T08:10:21.292534+00:00); reports as of 2026-09-13T08:10:21.292534+00:00 (Health Product Shortages Canada) Source: https://healthproductshortages.ca/search?term=02391805

Shortage record checked 2026-09-13T08:10:21.292534+00:00

Reason for Use code 420 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. Coverage limit: LU Authorization Period: 1 year Exceptional Access Program criteria on record (ministry list dated 2025-01-01, not exhaustive): Ministry criteria list dated January 1, 2025; the program's current criteria may differ; SADIE shows the current version. https://www.ontario.ca/page/sadie-special-authorization-digital-information-exchange 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. 19 Darbepoetin Brand(s): Aranesp DOSAGE FORM/ STRENGTH: Prefilled syringes:150 mcg, 200 mcg, 300 mcg, 500 mcg 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 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 20 EAP source: eap-frequently-requested-drugs-2025-01-01.txt, page 19, record 1, corpus 2025-01-01; name match only, not an eligibility decision

Turnaround times The Exceptional Access Program receives between 250 and 500 requests a day. Requests are categorized in order of priority based on how quickly a drug is needed, the type of drug, and the condition for which the drug is being used. Turnaround times begin on the business day on which the EAP receives a complete request from a physician or nurse practitioner. You may have to wait longer if the request is missing information or supporting documents required by the EAP criteria, if a request requires external review, or if documents are sent by fax or mail instead of submitted via SADIE. EAP Weekly Progress Report Date: September 15, 2026 Processing categories and examples | Target | Current | Priority 1 — for drugs such as antibiotics, cancer medications, and initial requests for pain medications | 3 business days | 2 business day | Priority 2 — for antiviral drugs to treat HIV, drugs for multiple sclerosis, and pulmonary hypertension | 5 business days | 3 business days | Biologics — for biologic drugs to treat rheumatoid arthritis, psoriatic arthritis, ulcerative colitis and Crohn’s disease | 10 business days | 4 business days | Chronic — for drugs used for chronic conditions such as migraines, chronic pain, Ménière's disease and symptoms of Parkinson’s disease. | 4 to 6 weeks | 11 business days | (ontario.ca, Updated September 15, 2026 ↗) For selected drugs, the Telephone Request Service is available to authorized prescribers or their delegates. In most cases, the funding decision is provided by the end of the call and processed within one business day. (ontario.ca, Updated September 15, 2026 ↗)

Aranesp · DIN 02391821 Manufacturer: Amgen Canada Inc.; listing date 2014-01-30 Health Canada: Marketed since 2013-11-04 · brand ARANESP · ATC B03XA02 DARBEPOETIN ALFA · form Solution · route Subcutaneous, Intravenous · ingredients DARBEPOETIN ALFA 500 MCG/ML · company Amgen canada inc · schedule Prescription, Schedule d

DIN 02391821: Aranesp Raw flags: sec12=Y, sec3=Y Item: 201600038; group id 266; item number 0537; lccId 00213; manufacturer id AMG Source form: Pref Syr-0.6mL Pk; strength: 300mcg/0.6mL Recorded listing: Limited Use: paid only with a Reason for Use code and the criteria below Source prices (unrounded): $1082.9500; ministry $1082.9500 Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02391821 Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=87714

Shortage status: no shortage or discontinuation reported (checked 2026-09-13T08:10:21.292534+00:00); reports as of 2026-09-13T08:10:21.292534+00:00 (Health Product Shortages Canada) Source: https://healthproductshortages.ca/search?term=02391821

Shortage record checked 2026-09-13T08:10:21.292534+00:00

Reason for Use code 420 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. Coverage limit: LU Authorization Period: 1 year Exceptional Access criteria on record are for Brand(s): Aranesp; DOSAGE FORM/ STRENGTH: Prefilled syringes: 150 mcg, 200 mcg, 300 mcg, — not this product; no criteria on record for this product in this block. Exceptional Access Program criteria on record (ministry list dated 2025-01-01, not exhaustive): Ministry criteria list dated January 1, 2025; the program's current criteria may differ; SADIE shows the current version. https://www.ontario.ca/page/sadie-special-authorization-digital-information-exchange 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. 19 Darbepoetin Brand(s): Aranesp DOSAGE FORM/ STRENGTH: Prefilled syringes:150 mcg, 200 mcg, 300 mcg, 500 mcg 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 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 20 EAP source: eap-frequently-requested-drugs-2025-01-01.txt, page 19, record 1, corpus 2025-01-01; name match only, not an eligibility decision

Aranesp · DIN 02392364 Manufacturer: Amgen Canada Inc.; listing date 2014-04-30 Health Canada: Marketed since 2014-02-24 · brand ARANESP · ATC B03XA02 DARBEPOETIN ALFA · form Solution · route Intravenous, Subcutaneous · ingredients DARBEPOETIN ALFA 500 MCG/ML · company Amgen canada inc · schedule Schedule d, Prescription

DIN 02392364: Aranesp Raw flags: sec12=Y, sec3=Y Item: 201600039; group id 266; item number 0538; lccId 00213; manufacturer id AMG Source form: Pref Syr-1.0mL Pk; strength: 500mcg/1.0mL Recorded listing: Limited Use: paid only with a Reason for Use code and the criteria below Source prices (unrounded): $1804.9400; ministry $1804.9400 Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02392364 Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=87764

Shortage status: no shortage or discontinuation reported (checked 2026-09-13T08:10:21.292534+00:00); reports as of 2026-09-13T08:10:21.292534+00:00 (Health Product Shortages Canada) Source: https://healthproductshortages.ca/search?term=02392364

Shortage record checked 2026-09-13T08:10:21.292534+00:00