Darbepoetin Alfa (1 brand name, 1 dosage form, 2 routes)
Available dosage forms: VIAL.
Routes of administration: SUBCUTANEOUS, INTRAVENOUS.
Brand Names
- ARANESP
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 [ 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 )] .
Contraindications
Aranesp is contraindicated in patients with: Uncontrolled hypertension [see Warnings and Precautions ( 5.3 )]. Pure red cell aplasia (PRCA) that begins after treatment with Aranesp or other erythropoietin protein drugs [see Warnings and Precautions ( 5.6 )]. Serious allergic reactions to Aranesp [see Warnings and Precautions ( 5.7 )].
Adverse Reactions
The following clinically significant adverse reactions are discussed in greater detail in other sections of the label: Increased Mortality, Myocardial Infarction, Stroke, and Thromboembolism [see Warnings and Precautions ( 5.1 )] Increased Mortality and/or Increased Risk of Tumor Progression or Recurrence in Patients with Cancer [see Warnings and Precautions ( 5.2 )] Hypertension [see Warnings and Precautions ( 5.3 )] Seizures [see Warnings and Precautions ( 5.4 )] Pure Red Cell Aplasia [see Warnings and Precautions ( 5.6 )] Serious Allergic Reactions [see Warnings and Precautions ( 5.7 )] Severe Cutaneous Reactions [see Warnings and Precautions ( 5.8 )]
Mechanism of Action
Aranesp stimulates erythropoiesis by the same mechanism as endogenous erythropoietin.
Overdosage
Aranesp overdosage can cause hemoglobin levels above the desired level, which should be managed with discontinuation or reduction of Aranesp dosage and/or with phlebotomy, as clinically indicated [see Clinical Pharmacology ( 12.2 ) ]. Cases of severe hypertension have been observed following overdose with ESAs [see Warnings and Precautions ( 5.3 )] .