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Aranesp (darbepoetin alfa) is a man-made form of a protein that helps your body produce red blood cells. This protein may be reduced when you have kidney failure or use certain medications. When fewer red blood cells are produced, you can develop a condition called anemia.
Aranesp is used to treat anemia caused by chemotherapy or chronic kidney disease.
Aranesp can increase your risk of life-threatening heart or circulation problems, including heart attack or stroke. Seek emergency medical help if you have: chest pain, shortness of breath, sudden numbness or weakness, confusion, problems with vision or balance, trouble speaking or understanding, or pain or coldness in an arm or leg.
Aranesp may also shorten remission time or survival time in some people with certain types of cancer. Talk with your doctor about the risks and benefits of using darbepoetin alfa.
Before using Aranesp, tell your doctor if you have heart disease, congestive heart failure, high blood pressure, kidney disease, a blood cell or clotting disorder, cancer, a seizure disorder, a latex allergy, or a history of stroke, heart attack, or blood clots.
You should not use this medicine if you have uncontrolled high blood pressure, or if you have ever had pure red cell aplasia (PRCA, a type of anemia) caused by using darbepoetin alfa or epoetin alfa (Epogen or Procrit).
To be sure Aranesp is helping your condition, your blood may need to be tested often. Your blood pressure will also need to be checked. Visit your doctor regularly.
Contact your doctor if you feel light-headed or unusually weak or tired. These may be signs that your body has stopped responding to Aranesp.
You should not use Aranesp if you are allergic to darbepoetin alfa, or if you have:
untreated or uncontrolled high blood pressure; or
if you have ever had pure red cell aplasia (PRCA, a type of anemia) caused by using Aranesp or epoetin alfa.
Aranesp may shorten remission time in some people with head and neck cancer who are also being treated with radiation. Darbepoetin alfa may also shorten survival time in certain people with breast cancer, non-small cell lung cancer, head and neck cancer, cervical cancer, or lymphoid cancer. Talk with your doctor about the risks and benefits of using this medicine.
Tell your doctor if you have ever had:
heart disease, high blood pressure;
kidney disease (or if you are on dialysis);
a stroke, heart attack, or blood clot;
a seizure; or
a latex allergy.
Tell your doctor if you are pregnant or breast-feeding.
Use Aranesp exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose.
Aranesp is given every 1 to 4 weeks, depending on the condition you are treating. You may also need to take blood pressure medication. Follow your doctor's instructions very carefully.
Aranesp is injected under the skin, or given as an infusion into a vein. A healthcare provider will give your first dose and may teach you how to properly use the medication by yourself.
Read and carefully follow any Instructions for Use provided with your medicine. You must know how to properly measure a full or partial dose of this medicine. Ask your doctor or pharmacist if you don't understand all instructions.
Do not shake the medicine. Prepare an injection only when you are ready to give it. Do not use if the medicine has changed colors or has particles in it. Call your pharmacist for new medicine.
You may need frequent medical tests to be sure this medicine is not causing harmful effects. Your injections may be delayed based on the results of these tests.
Call your doctor if you feel weak, tired, light-headed, or short of breath, or if your skin looks pale. These may be signs that your body has stopped responding to Aranesp.
If you need surgery, tell the surgeon ahead of time that you are using this medicine.
Store in the refrigerator and protect from light. Do not freeze Aranesp, and throw away the medicine if it has become frozen.
Each vial (bottle) or prefilled syringe is for one use only. Throw it away after one use, even if there is still medicine left inside.
Use a needle and syringe only once and then place them in a puncture-proof "sharps" container. Follow state or local laws about how to dispose of this container. Keep it out of the reach of children and pets.
Usual Adult Dose of Aranesp for Anemia Associated with Chronic Renal Failure:
Chronic Kidney Disease (CKD) Patients Not on Dialysis:
Initial dose: 0.45 mcg/kg IV or subcutaneously once every 4 weeks as appropriate
Comments:
-Initiate treatment only when hemoglobin is less than 10 g/dL, rate of hemoglobin decline indicates likelihood of requiring RBC transfusion, and reducing risk of alloimmunization and/or other RBC transfusion-related risks is a goal.
CKD Patients on Dialysis:
Initial dose: 0.45 mcg/kg IV or subcutaneously once a week or 0.75 mcg/kg once every 2 weeks as appropriate
Comments:
-Initiate treatment when hemoglobin is less than 10 g/dL.
-IV route is recommended for patients on hemodialysis.
Usual Adult Dose of Aranesp for Anemia Associated with Chemotherapy:
Initial dose: 2.25 mcg/kg subcutaneously once a week or 500 mcg subcutaneously once every 3 weeks
Duration of therapy: Until completion of chemotherapy course
Comments:
-Initiate treatment if hemoglobin is less than 10 g/dL and a minimum of 2 additional months of chemotherapy is planned.
-Use the lowest dose necessary to avoid RBC transfusions.
Use: Treatment of anemia in patients with non-myeloid malignancies where anemia is due to the effect of concomitant myelosuppressive chemotherapy.
Usual Pediatric Dose of Aranesp for Anemia Associated with Chronic Renal Failure:
Less than 18 Years:
Initial dose:
-Chronic Kidney Disease (CKD) Patients Not on Dialysis: 0.45 mcg/kg IV or subcutaneously once a week or 0.75 mcg/kg once every 2 weeks
-CKD Patients on Dialysis: 0.45 mcg/kg IV or subcutaneously once a week
Comments: Initiate treatment when hemoglobin is less than 10 g/dL.
Call your doctor for instructions if you miss a dose of Aranesp.
Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.
Follow your doctor's instructions about any restrictions on food, beverages, or activity.
Get emergency medical help if you have signs of an allergic reaction to Aranesp (hives, wheezing, difficult breathing, severe dizziness or fainting, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning in your eyes, skin pain, red or purple skin rash that spreads and causes blistering and peeling).
Darbepoetin alfa can increase your risk of life-threatening heart or circulation problems, including heart attack or stroke. This risk will increase the longer you use Aranesp. Seek emergency medical help if you have:
heart attack symptoms - chest pain or pressure, shortness of breath, pain spreading to your jaw or shoulder, nausea, sweating;
signs of a stroke - sudden numbness or weakness (especially on one side of the body), confusion, sudden severe headache, slurred speech, problems with vision or balance;
signs of a blood clot - pain, swelling, warmth, redness, cold feeling, or pale appearance of an arm or leg; or
increased blood pressure - severe headache, blurred vision, pounding in your neck or ears, anxiety, nosebleed.
Call your doctor at once if you have:
a light-headed feeling, like you might pass out;
unusual weakness or tiredness;
a seizure (convulsions); or
shortness of breath (even with mild exertion), swelling, rapid weight gain.
Common Aranesp side effects may include:
low blood pressure during dialysis;
cough, trouble breathing;
stomach pain; or
swelling in your arms or legs.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Other drugs may interact with Aranesp, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.
Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use Aranesp only for the indication prescribed.
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
Medically reviewed by USARx EDITORIAL TEAM Last updated on 1/1/2020.
Source: Drugs.com Aranesp Albumin Free (www.drugs.com/aranesp.html).
Note: This document contains side effect information about darbepoetin alfa. Some of the dosage forms listed on this page may not apply to the brand name Aranesp.
Common side effects of Aranesp include: hypertension and peripheral edema. Other side effects include: congestive heart failure and hypervolemia. See below for a comprehensive list of adverse effects.
Applies to darbepoetin alfa: injection solution
Injection route (Solution)
Erythropoiesis-stimulating agents (ESAs) increase the risk for death, myocardial infarction, stroke, and other serious cardiovascular events. Patients with chronic kidney disease (CKD) were at a greater risk for death, serious adverse cardiovascular reactions, and stroke when administered ESAs to target Hb levels of greater than 11 g/dL in clinical studies. No trial has identified a Hb target level, ESA dose, or dosing strategy that does not increase these risks. In CKD patients, use the lowest sufficient dose to reduce the need for RBC transfusions. In cancer patients with certain tumor types (ie, breast, non-small cell lung, head and neck, lymphoid, cervical), ESAs shortened overall survival and increased the risk of tumor progression or recurrence in clinical studies. In cancer patients, use the lowest dose needed to avoid RBC transfusions to reduce these risks and the risk of serious cardiovascular and thromboembolic reactions. Use ESAs only for treatment of anemia due to concomitant myelosuppressive chemotherapy, and discontinue following the completion of a chemotherapy course. Patients receiving myelosuppressive therapy when the anticipated outcome is cure should not be treated with ESAs.
Along with its needed effects, darbepoetin alfa (the active ingredient contained in Aranesp) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur while taking darbepoetin alfa:
More common
Less common
Rare
Incidence not known
Some side effects of darbepoetin alfa may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
More common
Applies to darbepoetin alfa: injectable solution
The most common adverse reactions in patients with chronic kidney disease (CKD) were hypertension, dyspnea, peripheral edema, cough, and procedural hypotension. The most common adverse reactions in cancer patients receiving chemotherapy were abdominal pain, edema, and thrombovascular events.
Very common (10% or more): Nausea (up to 38%), vomiting (up to 27%), diarrhea (up to 20%), constipation (up to 19%), abdominal pain (up to 16%)
Common (1% to 10%): Dyspepsia
Very common (10% or more): Fatigue (up to 32%), fever (up to 19%), peripheral edema (up to 17%), asthenia (up to 16%), edema (up to 12.8%), procedural hypotension (10%), chest pain (up to 10%)
Common (1% to 10%): Death, influenza-like symptoms, fluid overload, fall, contusion, pain, arteriovenous graft thrombosis
Very common (10% or more): Hypertension (up to 31%), hypotension (up to 22%)
Common (1% to 10%): Myocardial infarction, thrombotic events, angina pectoris
Frequency not reported: Arrhythmia, thromboembolism, thrombosis, thrombophlebitis
Very common (10% or more): Myalgia (up to 20%), back pain (14%), arthralgia (up to 13%), limb pain (up to 11%)
Common (1% to 10%): Skeletal pain
Very common (10% or more): Dyspnea (up to 20%), upper respiratory infection (up to 14%), cough (up to 12%), nasopharyngitis (11%)
Common (1% to 10%): Bronchitis, sinusitis, sore throat, pulmonary embolism
Frequency not reported: Epistaxis, allergic bronchospasm
Very common (10% or more): Headache (up to 16%), dizziness (up to 14%)
Common (1% to 10%): Cerebrovascular accident/transient ischemic attack, convulsions, paresthesia, hypoesthesia, cerebrovascular disorders, stroke
Frequency not reported: Somnolence
Very common (10% or more): Urinary tract infection (15%)
Very common (10% or more): Chronic renal failure (15%)
Very common (10% or more): Hypoglycemia (14%)
Very common (10% or more): Insomnia (11%)
Common (1% to 10%): Depression, anxiety
Common (1% to 10%): Pruritus, cellulitis, rash, skin ulcer, alopecia
Frequency not reported: Angioedema, urticaria
Postmarketing reports: Severe cutaneous reaction
Common (1% to 10%): Injection site pain, access hemorrhage, access infection, vascular access thrombosis, vascular access complications
Common (1% to 10%): Granulocytopenia
Frequency not reported: Anemia, pure red cell aplasia associated with neutralizing antibodies to erythropoietin
Common (1% to 10%): Metastatic neoplasm
Frequency not reported: Serious allergic reaction, hypersensitivity reaction, anaphylactic reaction
Medically reviewed by USARx EDITORIAL TEAM Last updated on 1/1/2020.
Source: Drugs.com Aranesp Albumin Free (www.drugs.com/aranesp.html).
August 6, 2020
August 6, 2020
August 6, 2020
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August 6, 2020
