Last reviewed 2026-04-20 · How we verify

Aranesp (DARBEPOETIN ALFA)

Aranesp works by binding to the erythropoietin receptor, mimicking the action of natural erythropoietin to stimulate red blood cell production.

Aranesp (darbepoetin alfa) is a recombinant erythropoiesis-stimulating agent developed by AMGEN, targeting the erythropoietin receptor to stimulate red blood cell production. It is used to treat anemia caused by chemotherapy and chronic kidney disease. Aranesp was FDA-approved in 2001 and remains a branded product. Key safety considerations include the risk of thromboembolic events and tumor progression. Aranesp's commercial status is patented.

At a glance

Mechanism of action

Aranesp stimulates erythropoiesis by the same mechanism as endogenous erythropoietin.

Approved indications

• Anemia due to and following chemotherapy
• Anemia of renal disease

Boxed warnings

• WARNING: ESAs INCREASE THE RISK OF DEATH, MYOCARDIAL INFARCTION, STROKE, VENOUS THROMBOEMBOLISM, THROMBOSIS OF VASCULAR ACCESS AND TUMOR PROGRESSION OR RECURRENCE Chronic Kidney Disease: In controlled trials, patients experienced greater risks for death, serious adverse cardiovascular reactions, and stroke when administered erythropoiesis -stimulating agents (ESAs) to target a hemoglobin level of greater than 11 g/dL [ see Warnings and Precautions ( 5.1 )] . No trial has identified a hemoglobin target level, Aranesp dose, or dosing strategy that does not increase these risks [see Dosage and Administration ( 2.2 )] . Use the lowest Aranesp dose sufficient to reduce the need for red blood cell (RBC) transfusions [see Warnings and Precautions ( 5.1 )] . Cancer: ESAs shortened overall survival and/or increased the risk of tumor progression or recurrence in clinical studies of patients with breast, non- small cell lung, head and neck, lymphoid, and cervical cancers [ see Warnings and Precautions ( 5.2 )] . To decrease these risks, as well as the risk of serious cardiovascular and thromboembolic reactions, use the lowest dose needed to avoid RBC transfusions [see Dosage and Administration ( 2.3 )] . Use ESAs only for anemia from myelosuppressive chemotherapy [see Indications and Usage ( 1.2 )]. ESAs are not indicated for patients receiving myelosuppressive chemotherapy when the anticipated outcome is cure [see Indications and Usage ( 1.3 )]. Discontinue following the completion of a chemotherapy course [see Dosage and Administration ( 2.3 )] . WARNING: ESAs INCREASE THE RISK OF DEATH, MYOCARDIAL INFARCTION, STROKE, VENOUS THROMBOEMBOLISM, THROMBOSIS OF VASCULAR ACCESS AND TUMOR PROGRESSION OR RECURRENCE See full prescribing information for complete boxed warning. Chronic Kidney Disease : In controlled trials, patients experienced greater risks for death, serious adverse cardiovascular reactions, and stroke when administered erythropoiesis - stimulating agents (ESAs) to target a hemoglobin level of greater than 11 g/dL ( 5.1 ). No trial has identified a hemoglobin target level, Aranesp dose, or dosing strategy that does not increase these risks ( 2.2 ) . Use the lowest Aranesp dose sufficient to reduce the need for red blood cell (RBC) transfusions ( 5.1 ). Cancer : ESAs shortened overall survival and/or increased the risk of tumor progression or recurrence in clinical studies of patients with breast, non - small cell lung, head and neck, lymphoid, and cervical cancers ( 5.2 ) . Use the lowest dose to avoid RBC transfusions ( 2.3 ) . Use ESAs only for anemia from myelosuppressive chemotherapy ( 1.2 ) . ESAs are not indicated for patients receiving myelosuppressive chemotherapy when the anticipated outcome is cure ( 1.3 ) . Discontinue following the completion of a chemotherapy course ( 2.3 ) .

Common side effects

• Hypertension
• Dyspnea
• Peripheral edema
• Cough
• Procedural hypotension
• Thromboembolic Adverse Reactions
• Arterial
• Angina pectoris
• Vascular access complications
• Fluid overload
• Rash/Erythema
• Arteriovenous graft thrombosis

Key clinical trials

• Luspatercept + Darbepoetin in MDS (PHASE2)
• Vafseo Outcomes In-Center Experience (PHASE3)
• Choices About Genetic Testing And Learning Your Risk With Smart Technology (NA)
• Darbe Plus IV Iron to Decrease Transfusions While Maintaining Iron Sufficiency in Preterm Infants (PHASE2)
• Efficacy and Safety Study to Evaluate MT-6548 in Non-dialysis Subjects With Anemia Associated With Chronic Kidney Disease in Japan (PHASE3)
• Efficacy and Safety Study to Evaluate MT-6548 in Hemodialysis Subjects Currently Receiving ESAs With Anemia Associated With Chronic Kidney Disease in Japan (PHASE3)
• A Study to Evaluate Efficacy and Safety of QLG1218(Daprodustat) in Chinese Hemodialysis (HD)-Dependent Subjects With Anemia Associated With Chronic Kidney Disease (CKD) (PHASE3)
• Darbepoetin in Patients Candidates for Liver Transplant. (EPO-LT Trial) (PHASE3)

Primary sources

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Competitive intelligence

For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:

• Aranesp CI brief — competitive landscape report
• Aranesp updates RSS · CI watch RSS
• Amgen portfolio CI