Darbepoetin alfa
ARANESP
What it isLong-acting erythropoietin-receptor agonist; anemia from CKD or myelosuppressive chemotherapy.
Why this oneAdded glycosylation prolongs erythropoietic stimulation and reduces injection frequency compared with epoetin.
What limits itHigher hemoglobin targets increase thrombosis, cardiovascular events, death, and tumor progression; monitor pressure and ensure iron.
FDA label
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| FDA dosing | Population | Start | Target | Max |
|---|---|---|---|---|
| Anemia due to CKD, on dialysis | Adults | 0.45 mcg/kg IV/SC weekly, or 0.75 mcg/kg IV/SC q2wk | lowest dose to reduce RBC transfusions (initiate when Hgb <10 g/dL) | individualized |
| Anemia due to CKD, not on dialysis | Adults | 0.45 mcg/kg IV/SC q4wk | lowest dose to reduce RBC transfusions | individualized |
| Anemia due to CKD | Pediatric | 0.45 mcg/kg IV/SC weekly (not on dialysis may start 0.75 mcg/kg q2wk) | lowest dose to reduce RBC transfusions | individualized |
| Anemia due to myelosuppressive chemotherapy in cancer | Adults | 2.25 mcg/kg SC weekly, or 500 mcg SC q3wk | lowest dose to avoid RBC transfusions | individualized |
Titration Do not increase dose more frequently than once every 4 weeks (CKD)
Renal Undefined
Hepatic Undefined
Dosing individualized to hemoglobin response; reduce/interrupt if Hgb rises rapidly (>1 g/dL in 2 weeks)
Instructions
- IV route recommended for patients on hemodialysis
- Do not shake; protect from light; do not dilute or co-administer with other drug solutions
- Evaluate iron status before and during treatment; supplement iron as needed
- Discontinue chemotherapy indication following completion of chemotherapy course
Contraindications
- Uncontrolled hypertension
- Pure red cell aplasia (PRCA) that begins after treatment with Aranesp or other erythropoietin protein drugs
Cautions
- Increased mortality, MI, stroke, thromboembolism at higher Hgb targets (>11 g/dL)
- Increased mortality/tumor progression in cancer
- Hypertension — control before and during treatment
- Seizures in CKD
- PRCA with neutralizing anti-erythropoietin antibodies
- Serious allergic reactions
- Severe cutaneous reactions (SJS/TEN)
Adverse reactions
- CKD: hypertension, dyspnea, peripheral edema, cough, procedural hypotension
- Cancer/chemotherapy: abdominal pain, edema, thrombovascular events
Pregnancy Limited data insufficient to determine risk; animal studies showed increased early post-implantation loss near clinical starting doses
Lactation No information on presence in human milk or effects on breastfed child/milk production
⚠ BOXED WARNING
- Increased mortality, myocardial infarction, stroke, thromboembolism and tumor progression
Classes and tags
Clinical profile
Mechanism of action: Darbepoetin alfa ballicule
