ARANESP
Aranesp (darbepoetin alfa) is an erythropoiesis-stimulating agent indicated for the treatment of anemia associated with chronic kidney disease in both dialysis and non-dialysis patients. It is also used to treat anemia in patients with non-myeloid malignancies receiving concomitant myelosuppressive chemotherapy where at least two additional months of treatment are planned. The medication is not indicated for use as a substitute for red blood cell transfusions when immediate correction of anemia is required. Additionally, Aranesp has not been demonstrated to improve quality of life, fatigue, or patient well-being.
How ARANESP Works
Aranesp acts as an erythropoiesis-stimulating agent to increase the production of red blood cells. It functions by stimulating erythropoiesis through the same biological mechanism as endogenous erythropoietin. By activating this process, the drug helps elevate red blood cell levels to treat anemia caused by kidney disease or chemotherapy.
Details
- Status
- Prescription
- First Approved
- 2001-09-17
- Routes
- SUBCUTANEOUS, INTRAVENOUS
- Dosage Forms
- VIAL
ARANESP Approval History
What ARANESP Treats
3 indicationsARANESP is approved for 3 conditions since its original approval in 2001. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Anemia due to chronic kidney disease in patients on dialysis
- Anemia due to chronic kidney disease in patients not on dialysis
- Anemia in patients with non-myeloid malignancies due to concomitant myelosuppressive chemotherapy
ARANESP Boxed 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 le...
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 ta
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Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
ARANESP FDA Label Details
ProIndications & Usage
FDA Label (PDF)Aranesp is an erythropoiesis-stimulating agent (ESA) indicated for the treatment of anemia due to: Chronic Kidney Disease (CKD) in patients on dialysis and patients not on dialysis . The effects of concomitant myelosuppressive chemotherapy, and upon initiation, there is a minimum of two additional months of planned chemotherapy . Limitations of Use Aranesp has not been shown to improve quality of life, fatigue, or patient well-being . Aranesp is not indicated for use: In patients with cancer receiving hormonal agents, biologic products, or radiotherapy, unless also receiving concomitant myelos...
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...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.