Erythropoiesis-stimulating AgentPrescription OnlyPregnancy Cat. Not classifiedFDA Yes
Aranesp
DARBEPOETIN ALFA
1 INDICATIONS AND USAGE Aranesp 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 i...
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Brand names:ARANESP
Quick Reference
Medicine ClassErythropoiesis-stimulating Agent
FDA ApprovedYes
PregnancyCategory Not classified
Quick Facts
- Active ingredient
- DARBEPOETIN ALFA
- Medicine class
- Erythropoiesis-stimulating Agent
- Brand names
- ARANESP
- Availability
- Prescription only (Rx)
- Pregnancy category
- Not classified
- Half-life
- half-life of approximately 1
- FDA approved
- Yes
What Is Aranesp?
1 INDICATIONS AND USAGE Aranesp 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 i...
Aranesp (DARBEPOETIN ALFA) belongs to the Erythropoiesis-stimulating Agent class of medications. It was first approved by the FDA in Yes. This medication requires a prescription from a licensed healthcare provider.
Key Safety Information
- •Always follow the dose recommended by your healthcare professional. Taking more than prescribed increases the risk of side effects including serious complications.
- •Seek emergency care if you experience signs of an allergic reaction — hives, swelling, difficulty breathing, or rash. Stop the medication and call your doctor immediately.
- •Some medications can increase the risk of cardiovascular events. Tell your doctor if you have high blood pressure, a history of heart attack or stroke, or any pre-existing health condition.
- •Avoid or limit alcohol while taking Aranesp. Do not drink alcohol without first discussing it with your healthcare provider as it may increase adverse effects.
- •Take Aranesp with food or a full glass of water if stomach upset occurs. Stop use and talk to your doctor if you experience persistent stomach pain or GI symptoms.
- •Tell your doctor about all medications, supplements, and vitamins you take. Some combinations significantly increase the risk of harm.
This is a summary only. Always read the full prescribing information and consult your healthcare provider for personalized medical advice.
Uses & Indications
Aranesp is prescribed for the following conditions. Some uses are FDA-approved indications; others may be evidence-based off-label uses. Consult your healthcare provider for personalized guidance.
1 INDICATIONS AND USAGE Aranesp 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 ).
In patients with cancer receiving myelosuppressive chemotherapy when the anticipated outcome is cure ( 1.3 ).
In patients with cancer receiving myelosuppressive chemotherapy in whom the anemia can be managed by transfusion ( 1.3 ).
As a substitute for RBC transfusions in patients who require immediate correction of anemia ( 1.3 ).
1.1 Anemia Due to Chronic Kidney Disease Aranesp is indicated for the treatment of anemia due to chronic kidney disease (CKD), including patients on dialysis and patients not on dialysis.
Dosage Guide
The following are general dosing guidelines only. Your actual dose should be determined by your healthcare provider based on your condition, renal/hepatic function, and other medications.
AD
Adult Dosage
2 DOSAGE AND ADMINISTRATION Recommended starting dose for patients with CKD on dialysis ( 2.2 ): - 0.45 mcg/kg intravenously or subcutaneously weekly, or - 0.75 mcg/kg intravenously or subcutaneously every 2 weeks - Intravenous route is recommended for patients on hemodialysis Recommended starting dose for patients with CKD not on dialysis ( 2.2 ): - 0.45 mcg/kg intravenously or subcutaneously at 4 week intervals Recommended starting dose for pediatric patients with CKD: - 0.45 mcg/kg intravenously or subcutaneously weekly - patients with CKD not on dialysis may also be initiated at 0.75 mcg/kg every 2 weeks Recommended starting dose for patients with cancer on chemotherapy ( 2.3 ): - 2.25 mcg/kg subcutaneously weekly, or - 500 mcg subcutaneously every 3 weeks 2.1 Important Dosing Information Evaluation of Iron Stores and Nutritional Factors Evaluate the iron status in all patients before and during treatment. Administer supplemental iron therapy when serum ferritin is less than 100 mc
Available Forms
Available Strengths
Side Effects
Common
- 6 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 )] Patients with CKD: Adverse reactions in ≥ 10% of Aranesp-treated patients in clinical studies were hypertension, dyspnea, peripheral edema, cough, and procedural hypotension ( 6.1 ).
- Patients with Cancer Receiving Chemotherapy: Adverse reactions in ≥ 1% of Aranesp-treated patients in clinical studies were abdominal pain, edema, and thrombovascular events ( 6.1 ).
- To report SUSPECTED ADVERSE REACTIONS, contact Amgen Medical Information at 1-800-77-AMGEN (1-800-772-6436) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
- 6.1 Clinical Trial Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of other drugs and may not reflect the rates observed in practice.
- Patients with Chronic Kidney Disease Adult Patients Adverse reactions were determined based on pooled data from 5 randomized, active-controlled studies of Aranesp with a total of 1357 patients (Aranesp 766, epoetin alfa 591).
- The median duration of exposure for patients receiving Aranesp was 340 days, with 580 patients exposed for greater than 6 months and 360 patients exposed for greater than 1 year.
- The median (25 th , 75 th percentiles) weight-adjusted dose of Aranesp was 0.50 mcg/kg (0.32, 0.81).
Serious
- 5 WARNINGS AND PRECAUTIONS Increased Mortality, Myocardial Infarction, Stroke, and Thromboembolism: Using Aranesp 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 ( 5.1 and 14.1 ).
- Use caution in patients with coexistent cardiovascular disease and stroke ( 5.1 ).
- Increased Mortality and/or Increased Risk of Tumor Progression or Recurrence in Patients with Cancer ( 5.2 ).
- Hypertension: Control hypertension prior to initiating and during treatment with Aranesp ( 5.3 ).
- Seizures: Aranesp increases the risk for seizures in patients with CKD ( 5.4 ).
Rare
Medicine Interactions
Always inform your healthcare provider and pharmacist about ALL medications you take, including prescriptions, OTC medicines, vitamins, and supplements.
MajorModerateMinor
Warnings & Contraindications
5 WARNINGS AND PRECAUTIONS Increased Mortality, Myocardial Infarction, Stroke, and Thromboembolism: Using Aranesp 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 ( 5.1 and 14.1 ). Use caution in patients with coexistent cardiovascular disease and stroke ( 5.1 ). Increased Mortal
How Aranesp Works
12.1 Mechanism of Action Aranesp stimulates erythropoiesis by the same mechanism as endogenous erythropoietin.
Pharmacokinetics
Absorption
absorption was slow and C max occurred at 48 hours (range: 12 to 72 hours)
Half-Life
half-life of approximately 1
Pregnancy & Breastfeeding Safety
Not classified
Breastfeeding
Many medications pass into breast milk in varying amounts. Before using Aranespwhile breastfeeding, discuss the benefits and risks with your healthcare provider or pharmacist — they can weigh your dose, your infant's age, and available lactation safety data to find the safest option for you and your baby.
Storage & Handling
Store at room temperature. Keep away from moisture and heat. Keep out of reach of children.
Frequently Asked Questions
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Adult, pediatric, renal, and hepatic dosing for Aranesp
- Detail
Aranesp side effects
Complete adverse effect profile including common, serious, and rare reactions
Sources & References
- • FDA Prescribing Information — Official labeling and package insert for Aranesp
- • U.S. National Library of Medicine — MedlinePlus drug information
- • American Hospital Formulary Service (AHFS) — Clinical pharmacology monograph
- • PubMed / MEDLINE — View clinical studies
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Medical Disclaimer
The information on this page is for educational purposes only and is not intended as medical advice, diagnosis, or treatment. Always consult your doctor, pharmacist, or qualified healthcare provider before starting, stopping, or changing any medication.