Darbepoetin - AlfaAranesp - Albumin Free - In a nutshell.

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Pharma Guru

Pharma Guru

Күн бұрын

Darbepoetin Alfa
Aranesp (Albumin Free)
How to Pronounce
Aranesp
Pharmacologic Category
Colony Stimulating Factor; Erythropoiesis-Stimulating Agent (ESA); Hematopoietic Agent
Labeled Indications
Anemia due to chemotherapy in patients with cancer: Treatment of anemia in patients with nonmyeloid malignancies when anemia is due to the effect of concomitant myelosuppressive chemotherapy, and upon initiation, there is a minimum of 2 additional months of planned chemotherapy.
Anemia due to chronic kidney disease: Treatment of anemia due to chronic kidney disease, including patients on dialysis and patients not on dialysis.
Off-Label: Adult
​Myelodysplastic syndromes, lower-risk (symptomatic anemia management)
US Boxed Warning
​Cardiovascular events:
​Chronic kidney disease:
​Cancer:
Erythropoiesis-stimulating agents (ESAs) increase the risk of death, myocardial infarction (MI), stroke, venous thromboembolism, thrombosis of vascular access.
In controlled trials, patients experienced greater risks for death, serious adverse cardiovascular reactions, and stroke when administered ESAs to target a hemoglobin level of more than 11 g/dL.
No trial has identified a hemoglobin target level, darbepoetin alfa dose, or dosing strategy that does not increase these risks.
Use the lowest darbepoetin alfa dose sufficient to reduce the need for red blood cell (RBC) transfusions.
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.
To decrease these risks, as well as the risk of serious cardiovascular and thromboembolic reactions, use the lowest dose needed to avoid RBC transfusion.
Use ESAs only for treatment of anemia from myelosuppressive chemotherapy.
ESAs are not indicated for patients receiving myelosuppressive chemotherapy when the anticipated outcome is cure.

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