What is the generic name?

DARBEPOETIN ALFA

What is the Trade Name for DARBEPOETIN ALFA?

ARANESP

What are the Indications for DARBEPOETIN ALFA?

• 1 INDICATIONS AND USAGE 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 ( 1.1 ). The effects of concomitant myelosuppressive chemotherapy, and upon initiation, there is a minimum of two additional months of planned chemotherapy ( 1.2 ). Limitations of Use Aranesp has not been shown to improve quality of life, fatigue, or patient well-being ( 1.3 ). Aranesp is not indicated for use: In patients with cancer receiving hormonal agents, biologic products, or radiotherapy, unless also receiving concomitant myelosuppressive chemotherapy ( 1.3 ). In patients with cancer receiving myelosuppressive chemotherapy when the anticipated outcome is cure ( 1.3 ). In patients with cancer receiving myelosuppressive chemotherapy in whom the anemia can be managed by transfusion ( 1.3 ). As a substitute for RBC transfusions in patients who require immediate correction of anemia ( 1.3 ). 1.1 Anemia Due to Chronic Kidney Disease Aranesp is indicated for the treatment of anemia due to chronic kidney disease (CKD), including patients on dialysis and patients not on dialysis. 1.2 Anemia Due to Chemotherapy in Patients with Cancer Aranesp is indicated for the treatment of anemia in patients with non-myeloid malignancies where anemia is due to the effect of concomitant myelosuppressive chemotherapy, and upon initiation, there is a minimum of two additional months of planned chemotherapy. 1.3 Limitations of Use Aranesp has not been shown to improve quality of life, fatigue, or patient well-being. Aranesp is not indicated for use: ‚Ä¢ In patients with cancer receiving hormonal agents, biologic products, or radiotherapy, unless also receiving concomitant myelosuppressive chemotherapy. ‚Ä¢ In patients with cancer receiving myelosuppressive chemotherapy when the anticipated outcome is cure. ‚Ä¢ In patients with cancer receiving myelosuppressive chemotherapy in whom the anemia can be managed by transfusion. ‚Ä¢ As a substitute for RBC transfusions in patients who require immediate correction of anemia.

References: https://open.fda.gov/