Darbepoetin Alfa

DEA Class; Rx

Common Brand Names; Aranesp

• Hematopoietic Growth Factors

Erythropoiesis-stimulating agent
Used for the treatment of anemia due to chronic kidney disease or due to the myelosuppressive effects of chemotherapy
Associated with increased risk of death, myocardial infarction, stroke, venous thromboembolism, vascular access thrombosis, and tumor progression or recurrence

Indicated for the treatment of anemia.

Uncontrolled hypertension

Hypersensitivity to any component

Pure red cell aplasia (PRCA) that begins after treatment with darbepoetin alfa or other erythropoietin protein drugs

Cancer patients

• Fatigue (33%)

• Diarrhea (22%)

• Edema (21%)

• Fever (19%)

• Dizziness (14%)

• Arthralgia (13%)

• Headache (12%)

• Death (10%)

Chronic renal failure patients

• Infectious disease (24%)

• Hyper/Hypotension (20%)

• Spasm (17%)

• Upper respiratory infection, Headache (15%)

• Diarrhea, Vomiting (14%)

• Nausea (11%)

• Peripheral edema, Dyspnea (10%)

• Abdominal pain (10%)

Increased mortality, myocardial infarction, stroke, and thromboembolism: Using ESAs to target a hemoglobin level of greater than 11 g/dL increases the risk of serious adverse cardiovascular reactions and has not been shown to provide additional benefit (see Black Box Warnings)

Hypertensive encephalopathy and seizures reported in patients with CKD; appropriately control hypertension prior to initiation of and during treatment; reduce or withhold Aranesp if blood pressure becomes difficult to control; advise patients of importance of compliance with antihypertensive therapy and dietary restrictions

For lack or loss of hemoglobin response to therapy, initiate a search for causative factors (eg, iron deficiency, infection, inflammation, bleeding); if typical causes of lack or loss of hemoglobin response are excluded, evaluate for PRCA; in absence of PRCA, follow dosing recommendations for management of patients with insufficient hemoglobin response to therapy

Use caution in known porphyria, sickle cell anemia, thalassemia

Serious allergic reactions, including anaphylactic reactions, angioedema, bronchospasm, skin rash, and urticaria may occur; immediately and permanently discontinue therapy and administer appropriate therapy if a serious allergic or anaphylactic reaction occurs

Decrease dose if Hgb increase exceeds 1 g/dL in any 2 wk period

Increased mortality and/or increased risk of tumor progression or recurrence in patients with cancer

Increases the risk for seizures in patients with CKD; increase monitoring of these patients for changes in seizure frequency or premonitory symptoms

If severe anemia and low reticulocyte count develop during treatment, withhold therapy and evaluate for pure red cell aplasia

Blistering and skin exfoliation reactions including erythema multiforme and Stevens-Johnson Syndrome (SJS)/Toxic Epidermal Necrolysis (TEN), reported in the post-marketing setting; discontinue therapy immediately if a severe cutaneous reaction, such as SJS/TEN, suspected

Two different excipients available: polysorbate 80 or human albumin

May use supplemental iron if serum ferritin <100 mcg/L [0.225 pmol/L] or serum transferrin saturation <20%

Limited available data on pregnant women are insufficient to determine a drug-associated risk of major birth defects or miscarriage

There is no information regarding presence of drug in human milk, effects on breastfed child, or on milk production

Darbepoetin alfa

injectable solution

• 25mcg/mL
• 40mcg/mL
• 60mcg/mL
• 100mcg/mL
• 200mcg/mL
• 300mcg/mL

prefilled syringe

• 25mcg
• 40mcg
• 60mcg
• 100mcg
• 150mcg
• 200mcg
• 300mcg
• 500mcg