Prescription medicine
Darbepoetin alfa Brand names: Aranesp
Darbepoetin alfa (Aranesp) is a prescription medicine with an FDA approval on record since 2001. No generic is listed; pharmacies paid $446.58 per mL (Aranesp 25 mcg/0.42 mL syring) in the October 7, 2026 NADAC survey.
- No generic listed
- Boxed warning
Check it at the source: the darbepoetin alfa FDA label on DailyMed (effective July 7, 2026, Amgen, Inc); the BLA 103951 record on Drugs@FDA; every darbepoetin alfa label on DailyMed.
Highlights of the record
FDA label of July 7, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
ESAs INCREASE THE RISK OF DEATH, MYOCARDIAL INFARCTION, STROKE, VENOUS THROMBOEMBOLISM, THROMBOSIS OF VASCULAR ACCESS AND TUMOR PROGRESSION OR RECURRENCE 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 )]. […]
Used for
From the label: indications and usageAranesp 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 ).
Forms and strengths
- 0.3ml
- 0.42ml
- 0.4ml
- 0.5ml
- 0.6ml
Injection (solution); solution.
On the market
- Earliest approval on file
- September 17, 2001 Aranesp, Amgen; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 1 of which 0 under generic applications, 1 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- $446.58 per mL Aranesp 25 mcg/0.42 mL syring
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 53,587 through July 30, 2026
What is darbepoetin alfa used for?
From the label: indications and usageAranesp 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 ). […]
Conditions named in the indications of darbepoetin alfa's FDA labels, with every medicine labeled for each:
FDA pharmacologic class: Erythropoiesis-stimulating Agent.
Source: FDA drug label (ARANESP), Amgen, Inc, effective July 7, 2026 (SPL set 0fd36cb9-c4f6-4167-93c9-8530865db3f9), via openFDA; the full label on DailyMed
What does the patient leaflet for darbepoetin alfa say first?
The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.
From the patient leaflet: What is the most important information I should know about Aranesp?Aranesp may cause serious side effects that can lead to death, including: For people with cancer: Your tumor may grow faster and you may die sooner if you choose to take Aranesp. Your healthcare provider will talk with you about these risks. For all people who take Aranesp, including people with cancer or chronic kidney disease: Serious heart problems, such as heart attack or heart failure, and stroke. You may die sooner if you are treated with Aranesp to increase red blood cells (RBCs) to near the same level found in healthy people. Blood clots. Blood clots may happen at any time while taking Aranesp. If you are receiving Aranesp for any reason and you are going to have surgery, talk to your healthcare provider about whether or not you need to take a blood thinner to lessen the chance of blood clots during or following surgery. Blood clots can form in blood vessels (veins), especially in your leg (deep venous thrombosis or DVT). Pieces of a blood clot may travel to the lungs and block the blood circulation in the lungs (pulmonary embolus). Call your healthcare provider or get medical help right away if you have any of these symptoms: Chest pain Trouble breathing or shortness of breath Pain in your legs, with or without swelling A cool or pale arm or leg Sudden confusion, trouble speaking, or trouble understanding others' speech Sudden numbness or weakness in your face, arm, or leg, especially on one side of your body Sudden trouble seeing Sudden trouble walking, dizziness, loss of balance or coordination Loss of consciousness (fainting) Hemodialysis vascular access stops working See “ What are the possible side effects of Aranesp? ” below for more information. […]
From the patient leaflet: How should I store Aranesp?Do not shake Aranesp. Store Aranesp in the carton it comes in to protect it from light. Store Aranesp in the refrigerator between 36°F to 46°F (2°C to 8°C). Do not freeze Aranesp. Do not use Aranesp that has been frozen. Throw away the Aranesp vial or prefilled syringe after one use. Do not re-use even if there is medicine left. Keep Aranesp and all medicines out of the reach of children.
Source: FDA drug label (ARANESP), Amgen, Inc, effective July 7, 2026 (SPL set 0fd36cb9-c4f6-4167-93c9-8530865db3f9), via openFDA; the full label on DailyMed
Is there a generic for darbepoetin alfa (Aranesp)?
No generic darbepoetin alfa is approved (Drugs@FDA, October 8, 2026).
- 2001 earliest approval on file
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for darbepoetin alfa (Aranesp)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $446.58 per mL (Aranesp 25 mcg/0.42 mL syring), about the same as a year earlier. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.
- Aranesp 25 mcg/0.42 mL syring (brand)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Aranesp 25 mcg/0.42 mL syring | Brand | $446.58 per mL | n/a | +0.1% |
| Aranesp 40 mcg/0.4 mL syringe | Brand | $752.44 per mL | $300.97 per single-dose syringe | +1% |
| Aranesp 60 mcg/0.3 mL syringe | Brand | $1,500.15 per mL | $450.04 per single-dose syringe | n/a |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
What does the darbepoetin alfa label say about other medicines?
The darbepoetin alfa label names 2 other medicines in its interaction, contraindication or warning sections. The labels of 3 other medicines name darbepoetin alfa. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Epoetin | warnings and precautions | Normal Hematocrit Study (NHS) (N = 12 65): Population; CHOIR (N = 1432): Adult patients with CKD on hemodialysis with coexisting CHF or CAD, hematocrit 30 ± 3% on epoetin alfa; TREAT (N = 4038): Adult patients with CKD not on dialysis with hemoglobin < 11 g/dL not previously administered epoetin alfa; … |
| Heparin | warnings and precautions | Patients receiving Aranesp may require increased anticoagulation with heparin to prevent clotting of the extracorporeal circuit during hemodialysis. |
Other labels that name darbepoetin alfa
Source: FDA drug label (ARANESP), Amgen, Inc, effective July 7, 2026 (SPL set 0fd36cb9-c4f6-4167-93c9-8530865db3f9), via openFDA; the full label on DailyMed
What do FAERS reports show for darbepoetin alfa?
The FDA Adverse Event Reporting System holds 53,587 reports that list darbepoetin alfa among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 19,851 are coded as a death and 23,976 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Reports rose sharply in 2017 (7,062, against a median of 1,680 a year): FAERS counts follow reporting, which news, litigation and label changes can drive, not how often a reaction happens.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What next?
- Other erythropoiesis-stimulating agents
- the pharmacologic class, with prices and generics
- Darbepoetin alfa side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other