Drug updated on 5/17/2024
Dosage Form | Injection (intravenous/subcutaneous; 25 mcg, 40 mcg, 60 mcg, 100 mcg, 200 mcg and 300 mcg); Injection (intravenous/subcutaneous; 10 mcg/0.4 mL, 25 mcg/0.42 mL, 40 mcg/0.4 mL, 60 mcg/0.3 mL, 100 mcg/0.5 mL, 150 mcg/0.3 mL, 200 mcg/0.4 mL, 300 mcg/0.6 mL, and 500 mcg/1 mL) |
Drug Class | Erythropoiesis-stimulating agents |
Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- Indicated for the treatment of anemia due to Chronic Kidney Disease (CKD) in patients on dialysis and patients not on dialysis.
- Indicated for the treatment of anemia due to the effects of concomitant myelosuppressive chemotherapy, and upon initiation, there is a minimum of two additional months of planned chemotherapy.
Latest News
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Summary
- Darbepoetin alfa (Aranesp) is recommended for the management of anemia due to Chronic Kidney Disease (CKD) in both dialysis and non-dialysis patients, as well as for anemia resulting from myelosuppressive chemotherapy. It is effective in preventing blood transfusions in adults with CKD, demonstrating similar efficacy to other erythropoiesis-stimulating agents such as epoetin alfa and beta.
- The information was derived from three systematic reviews/meta-analyses that compared Aranesp's safety and efficacy against placebo, other ESAs like epoetin alfa/beta, and novel treatments including vadadustat.
- In terms of mortality risk associated with its use, darbepoetin alfa shows no significant difference when compared to a placebo or other evaluated ESAs, indicating comparable safety concerns related to mortality.
- However, darbepoetin may increase the odds of hypertension more than a placebo does. This potential side effect is common among different erythropoiesis-stimulating agents used for treating anemia due to CKD.
- When comparing newer treatments like vadadustat or Hypoxia-inducible factor prolyl hydroxylase inhibitors (HIF-PHIs), there is no significant difference between them and darbepoetin alfa regarding hemoglobin level elevation or all-cause mortality rates; however, vadadustat might be slightly less effective at raising hemoglobin levels, specifically within dialysis-dependent chronic kidney disease patients.
- The studies considered various patient populations segmented into nondialysis-dependent (NDD) and dialysis-dependent (DD). Across these subgroups, Aranesp maintains a consistent efficacy profile while also indicating a possible increased risk of hypertension, which warrants specific considerations during treatment management.
Product Monograph / Prescribing Information
Document Title | Year | Source |
---|---|---|
Aranesp (darbepoetin alfa) Prescribing Information. | 2019 | Amgen Inc., Thousand Oaks, California |
Systematic Reviews / Meta-Analyses
Document Title | Year | Source |
---|---|---|
Erythropoiesis‐stimulating agents for anaemia in adults with chronic kidney disease: a network meta‐analysis. | 2023 | The Cochrane Database of Systematic Reviews |
Efficacy and safety of vadadustat compared to darbepoetin alfa on anemia in patients with chronic kidney disease: a meta-analysis. | 2022 | International Urology and Nephrology |
Efficacy and safety of HIF prolyl-hydroxylase inhibitor vs epoetin and darbepoetin for anemia in chronic kidney disease patients not undergoing dialysis: a network meta-analysis. | 2020 | Pharmacological Research |
Clinical Practice Guidelines
Document Title | Year | Source |
---|---|---|
Real-life anemia management among patients with non-dialysis-dependent chronic kidney disease in three European countries. | 2023 | International Journal of Nephrology and Renovascular Disease |
Anemia management in peritoneal dialysis: Perspectives from the Asia pacific region. | 2021 | Kidney Medicine |
Management of cancer-associated anemia with erythropoiesis-stimulating agents: ASCO/ASH clinical practice guideline update. | 2019 | Blood Advances |
Management of cancer-associated anemia with erythropoiesis-stimulating agents: ASCO/ASH clinical practice guideline update. | 2019 | Journal of Clinical Oncology |