Aranesp 60mcg Inj, 1ml
WARNING: This drug may raise the chance of heart attack, stroke, heart failure, blood clots, and death. Talk with the doctor.People with some types of cancer have died sooner when using this drug. This drug also raised the chance of tumor growth and the tumor happening again in these people. Talk with the doctor.Your doctor will need to watch your blood cell counts and follow you closely to change the dose to match your body's needs. Talk with your doctor. @ COMMON USES: It is used to treat anemia.
Drug Class
Erythropoiesis-stimulating agent (ESA)
Pharmacologic Class
Recombinant human erythropoietin analog
Pregnancy Category
Category C
FDA Approved
Oct 2001
DEA Schedule
Not Controlled
Overview
What is this medicine?
Aranesp is a medicine that helps your body make more red blood cells. It is used to treat anemia (low red blood cell count) in people with kidney disease or certain types of cancer who are receiving chemotherapy. It works like a natural substance in your body called erythropoietin.
How to Use This Medicine
Proper Use of This Medication
To use this medication correctly, follow your doctor's instructions and read all the information provided. This medication is administered via injection into the fatty tissue under the skin or into a vein during dialysis. If you are self-administering the injection, your doctor or nurse will provide guidance on the proper technique.
Continue using this medication as directed by your doctor or healthcare provider, even if you are feeling well. It is essential to handle the medication correctly: do not shake the container, and do not use it if it has been shaken or frozen. Before and after use, wash your hands thoroughly.
Inspect the solution before use; do not administer it if it appears cloudy, is leaking, contains particles, or has changed color. Avoid injecting into skin that is red or irritated. After administering the dose, discard any remaining medication and dispose of the needle in a designated sharps container. Do not reuse needles or other equipment. When the container is full, follow local regulations for disposal. If you have any questions or concerns, consult your doctor or pharmacist.
Storage and Disposal
Store this medication in the refrigerator, but do not freeze it.
Missed Dose
If you miss a dose, contact your doctor to determine the best course of action.
To use this medication correctly, follow your doctor's instructions and read all the information provided. This medication is administered via injection into the fatty tissue under the skin or into a vein during dialysis. If you are self-administering the injection, your doctor or nurse will provide guidance on the proper technique.
Continue using this medication as directed by your doctor or healthcare provider, even if you are feeling well. It is essential to handle the medication correctly: do not shake the container, and do not use it if it has been shaken or frozen. Before and after use, wash your hands thoroughly.
Inspect the solution before use; do not administer it if it appears cloudy, is leaking, contains particles, or has changed color. Avoid injecting into skin that is red or irritated. After administering the dose, discard any remaining medication and dispose of the needle in a designated sharps container. Do not reuse needles or other equipment. When the container is full, follow local regulations for disposal. If you have any questions or concerns, consult your doctor or pharmacist.
Storage and Disposal
Store this medication in the refrigerator, but do not freeze it.
Missed Dose
If you miss a dose, contact your doctor to determine the best course of action.
Lifestyle & Tips
- Maintain a healthy diet, especially ensuring adequate iron intake as advised by your doctor.
- Monitor your blood pressure regularly as instructed by your healthcare provider.
- Report any unusual symptoms immediately to your doctor.
- Do not stop taking Aranesp without consulting your doctor.
Available Forms & Alternatives
Available Strengths:
- Aranesp 500mcg/ml Inj Alb Free
- Aranesp 300mcg/0.6ml Inj Alb Free
- Aranesp 200mcg/0.4ml Inj Alb Free
- Aranesp 40mcg/0.4ml Inj Alb Free
- Aranesp 100mcg/ml Vl Albumin Free
- Aranesp 150mcg/0.3ml Inj Alb Free
- Aranesp 200mcg/ml Vl Albumin Free
- Aranesp 25mcg/ml Vl Albumin Free
- Aranesp 40mcg/ml Vl Albumin Free
- Aranesp 60mcg/ml Vl Albumin Free
- Aranesp 25mcg/ml Inj, 1ml
- Aranesp 40mcg/ml Inj Srclk Alb Free
- Aranesp 60mcg Inj, 1ml
- Aranesp 100mcg Inj , 1ml
- Aranesp 100mcg/0.5ml Sgjct Alb Free
- Aranesp 60mcg/0.3ml Sgjct Alb Free
- Aranesp 25mcg Inj, 0.42ml
- Aranesp 100mcg Albumin-Free Inj
- Aranesp 10mcg/0.4ml Singleject Syr
- Aranesp 60mcg/0.3ml Singleject Syr
Dosing & Administration
Adult Dosing
Standard Dose:
Varies significantly by indication and patient response. For CKD patients not on dialysis: Initial 0.45 mcg/kg IV or SC once weekly. For CKD patients on dialysis: Initial 0.45 mcg/kg IV or SC once weekly or 0.75 mcg/kg IV or SC once every 2 weeks. For chemotherapy-induced anemia: Initial 2.25 mcg/kg SC once weekly or 500 mcg SC once every 3 weeks.
Dose Range:
0.45 - 500 mg
Condition-Specific Dosing:
CKD_not_on_dialysis:
Initial 0.45 mcg/kg IV or SC once weekly. Target Hb 10-11 g/dL. Adjust dose by 25% increments/decrements.
CKD_on_dialysis:
Initial 0.45 mcg/kg IV or SC once weekly or 0.75 mcg/kg IV or SC once every 2 weeks. Target Hb 10-11 g/dL. Adjust dose by 25% increments/decrements.
Chemotherapy_induced_anemia:
Initial 2.25 mcg/kg SC once weekly or 500 mcg SC once every 3 weeks. Target Hb to avoid transfusions, not to exceed 12 g/dL. Discontinue after chemotherapy completion.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
For CKD patients 1 month to 16 years: Initial 0.45 mcg/kg IV or SC once weekly. Adjust dose by 25% increments/decrements to maintain Hb 10-12 g/dL.
Adolescent:
For CKD patients 1 month to 16 years: Initial 0.45 mcg/kg IV or SC once weekly. Adjust dose by 25% increments/decrements to maintain Hb 10-12 g/dL.
Dose Adjustments
Renal Impairment:
Mild:
No specific dose adjustment required, but dose should be individualized based on hemoglobin response.
Moderate:
No specific dose adjustment required, but dose should be individualized based on hemoglobin response.
Severe:
No specific dose adjustment required, but dose should be individualized based on hemoglobin response. Dose adjustments are based on hemoglobin levels and rate of rise.
Dialysis:
Darbepoetin alfa can be administered to patients on dialysis. Dosing is based on body weight and hemoglobin response, typically 0.45 mcg/kg IV or SC once weekly or 0.75 mcg/kg IV or SC once every 2 weeks.
Hepatic Impairment:
Mild:
No specific dose adjustment provided.
Moderate:
No specific dose adjustment provided.
Severe:
No specific dose adjustment provided. Use with caution due to limited data.
Pharmacology
Mechanism of Action
Darbepoetin alfa is an erythropoiesis-stimulating agent (ESA) that stimulates erythropoiesis by the same mechanism as endogenous erythropoietin. It interacts with the erythropoietin receptor on progenitor cells in the bone marrow to stimulate red blood cell production and differentiation. Darbepoetin alfa has a longer half-life than epoetin alfa due to its increased glycosylation, which results in more sialic acid residues.
Pharmacokinetics
Absorption:
Bioavailability:
Approximately 37% (SC), 100% (IV)
Tmax:
Approximately 48 hours (SC)
FoodEffect:
Not applicable (injectable)
Distribution:
Vd:
Approximately 0.06 L/kg (IV)
ProteinBinding:
Not available
CnssPenetration:
Limited
Elimination:
HalfLife:
Approximately 49 hours (SC), 21 hours (IV) in CKD patients; longer in healthy subjects.
Clearance:
Approximately 0.6 mL/hr/kg (IV)
ExcretionRoute:
Primarily renal and hepatic clearance.
Unchanged:
Minimal unchanged drug excreted in urine.
Pharmacodynamics
OnsetOfAction:
Increase in reticulocyte count typically seen within 7-10 days.
PeakEffect:
Hemoglobin levels begin to rise within 2-6 weeks.
DurationOfAction:
Effects persist for several days to weeks after last dose due to long half-life.
Safety & Warnings
BLACK BOX WARNING
Increased risk of death, myocardial infarction, stroke, venous thromboembolism, and tumor progression or recurrence. To decrease these risks, use the lowest dose of Aranesp sufficient to reduce the need for red blood cell transfusions. For patients with chronic kidney disease (CKD), Aranesp is not indicated for patients requiring immediate correction of anemia. For patients with cancer, Aranesp is not indicated for patients receiving myelosuppressive chemotherapy when the anticipated outcome is cure. Discontinue Aranesp when chemotherapy is completed.
Side Effects
Urgent Side Effects: Seek Medical Help Right Away
While rare, some people may experience severe and potentially life-threatening side effects when taking this medication. If you notice any of the following symptoms, contact your doctor or seek immediate medical attention:
Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin (with or without fever)
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of high blood pressure, including:
+ Severe headache or dizziness
+ Passing out
+ Changes in eyesight
Fast heartbeat
Shortness of breath
Sudden weight gain or swelling in the arms or legs
Weakness on one side of the body
Trouble speaking or thinking
Changes in balance
Drooping on one side of the face
Blurred eyesight
Feeling confused
Cool or pale arm or leg
Trouble walking
Dizziness or passing out
Excessive sweating
Seizures
Feeling extremely tired or weak
Pale skin
Blood Clots: Seek Medical Help Right Away
If you experience any of the following symptoms, which may indicate a blood clot, contact your doctor immediately:
Chest pain or pressure
Coughing up blood
Shortness of breath
Swelling, warmth, numbness, change of color, or pain in a leg or arm
Trouble speaking or swallowing
Severe Skin Reaction: Seek Medical Help Right Away
In rare cases, a severe skin reaction called Stevens-Johnson syndrome/toxic epidermal necrolysis may occur. This condition can cause severe health problems and may be life-threatening. If you notice any of the following symptoms, seek medical help immediately:
Red, swollen, blistered, or peeling skin (with or without fever)
Red or irritated eyes
Sores in your mouth, throat, nose, or eyes
Other Side Effects
Like all medications, this drug may cause side effects. While many people experience no side effects or only minor ones, some may encounter more bothersome symptoms. If you experience any of the following side effects or any other symptoms that concern you, contact your doctor:
Stomach pain
Cough
Reporting Side Effects
If you have questions about side effects or would like to report any adverse reactions, contact your doctor or the FDA at 1-800-332-1088. You can also report side effects online at https://www.fda.gov/medwatch.
While rare, some people may experience severe and potentially life-threatening side effects when taking this medication. If you notice any of the following symptoms, contact your doctor or seek immediate medical attention:
Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin (with or without fever)
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of high blood pressure, including:
+ Severe headache or dizziness
+ Passing out
+ Changes in eyesight
Fast heartbeat
Shortness of breath
Sudden weight gain or swelling in the arms or legs
Weakness on one side of the body
Trouble speaking or thinking
Changes in balance
Drooping on one side of the face
Blurred eyesight
Feeling confused
Cool or pale arm or leg
Trouble walking
Dizziness or passing out
Excessive sweating
Seizures
Feeling extremely tired or weak
Pale skin
Blood Clots: Seek Medical Help Right Away
If you experience any of the following symptoms, which may indicate a blood clot, contact your doctor immediately:
Chest pain or pressure
Coughing up blood
Shortness of breath
Swelling, warmth, numbness, change of color, or pain in a leg or arm
Trouble speaking or swallowing
Severe Skin Reaction: Seek Medical Help Right Away
In rare cases, a severe skin reaction called Stevens-Johnson syndrome/toxic epidermal necrolysis may occur. This condition can cause severe health problems and may be life-threatening. If you notice any of the following symptoms, seek medical help immediately:
Red, swollen, blistered, or peeling skin (with or without fever)
Red or irritated eyes
Sores in your mouth, throat, nose, or eyes
Other Side Effects
Like all medications, this drug may cause side effects. While many people experience no side effects or only minor ones, some may encounter more bothersome symptoms. If you experience any of the following side effects or any other symptoms that concern you, contact your doctor:
Stomach pain
Cough
Reporting Side Effects
If you have questions about side effects or would like to report any adverse reactions, contact your doctor or the FDA at 1-800-332-1088. You can also report side effects online at https://www.fda.gov/medwatch.
Seek Immediate Medical Attention If You Experience:
- Signs of a blood clot: chest pain, shortness of breath, pain/swelling in your leg or arm, sudden numbness or weakness on one side of your body, sudden severe headache, problems with vision or speech.
- Signs of high blood pressure: severe headache, blurred vision, dizziness, confusion, nausea, vomiting.
- Signs of an allergic reaction: rash, itching, hives, swelling of the face/lips/tongue/throat, difficulty breathing.
- Signs of pure red cell aplasia (PRCA): unusual tiredness, pale skin, shortness of breath, rapid heart rate, worsening anemia.
Before Using This Medicine
Before taking this medication, it is essential to inform your doctor about the following:
Any allergy to darbepoetin alfa or any other component of this medication. If you have an allergy, provide details about the allergic reaction and the symptoms you experienced.
A history of high blood pressure.
A diagnosis of Pure Red Cell Aplasia (PRCA), a specific type of anemia.
If you have cancer, discuss this with your doctor to determine the best course of action.
This list is not exhaustive, and it is crucial to disclose all your medications, including prescription and over-the-counter drugs, natural products, and vitamins, as well as any existing health problems, to your doctor and pharmacist. This will enable them to assess potential interactions and ensure safe use of this medication. Never start, stop, or modify the dose of any medication without consulting your doctor first.
Any allergy to darbepoetin alfa or any other component of this medication. If you have an allergy, provide details about the allergic reaction and the symptoms you experienced.
A history of high blood pressure.
A diagnosis of Pure Red Cell Aplasia (PRCA), a specific type of anemia.
If you have cancer, discuss this with your doctor to determine the best course of action.
This list is not exhaustive, and it is crucial to disclose all your medications, including prescription and over-the-counter drugs, natural products, and vitamins, as well as any existing health problems, to your doctor and pharmacist. This will enable them to assess potential interactions and ensure safe use of this medication. Never start, stop, or modify the dose of any medication without consulting your doctor first.
Precautions & Cautions
It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. If you are scheduled to undergo surgery, consult with your doctor, as you may require an alternative medication to prevent blood clots while taking this drug.
Regular blood pressure monitoring is crucial, as this medication can cause high blood pressure. Adhere to your doctor's instructions for blood pressure checks. Additionally, follow your doctor's guidance for regular blood work checks and discuss any concerns or questions with your doctor.
To minimize the risk of severe side effects, do not exceed the dosage prescribed by your doctor. If you accidentally take more than the recommended dose, contact your doctor immediately.
This medication increases red blood cell production in the blood. Be aware that misuse or abuse of this type of medication can lead to severe health complications, including stroke, heart attack, and blood clots. If you have any questions or concerns, consult with your doctor.
If you are pregnant, planning to become pregnant, or breastfeeding, inform your doctor. It is crucial to discuss the potential benefits and risks of this medication to both you and your baby.
Regular blood pressure monitoring is crucial, as this medication can cause high blood pressure. Adhere to your doctor's instructions for blood pressure checks. Additionally, follow your doctor's guidance for regular blood work checks and discuss any concerns or questions with your doctor.
To minimize the risk of severe side effects, do not exceed the dosage prescribed by your doctor. If you accidentally take more than the recommended dose, contact your doctor immediately.
This medication increases red blood cell production in the blood. Be aware that misuse or abuse of this type of medication can lead to severe health complications, including stroke, heart attack, and blood clots. If you have any questions or concerns, consult with your doctor.
If you are pregnant, planning to become pregnant, or breastfeeding, inform your doctor. It is crucial to discuss the potential benefits and risks of this medication to both you and your baby.
Overdose Information
Overdose Symptoms:
- Polycythemia (excessively high red blood cell count), which can lead to serious cardiovascular events like stroke, heart attack, or blood clots.
What to Do:
Seek immediate medical attention. Management typically involves phlebotomy (blood removal) to reduce red blood cell mass. Call 1-800-222-1222 (Poison Control) for advice.
Drug Interactions
Moderate Interactions
- No significant drug-drug interactions have been identified with darbepoetin alfa. However, drugs that affect erythropoiesis or iron metabolism may indirectly affect its efficacy.
Monitoring
Baseline Monitoring
Hemoglobin (Hb)
Rationale: To establish baseline and guide initial dosing.
Timing: Prior to initiation of therapy.
Iron status (serum ferritin, transferrin saturation [TSAT])
Rationale: Iron deficiency limits response to ESAs. Ensure adequate iron stores before and during therapy.
Timing: Prior to initiation of therapy.
Blood Pressure (BP)
Rationale: ESAs can cause or exacerbate hypertension.
Timing: Prior to initiation of therapy.
Complete Blood Count (CBC) with differential and platelet count
Rationale: To assess overall hematologic status and rule out other causes of anemia.
Timing: Prior to initiation of therapy.
Routine Monitoring
Hemoglobin (Hb)
Frequency: Weekly or bi-weekly until stable, then every 2-4 weeks.
Target: CKD: 10-11 g/dL; CIA: lowest Hb to avoid transfusions, not to exceed 12 g/dL.
Action Threshold: If Hb rises rapidly (>1 g/dL in 2 weeks) or exceeds target range, reduce dose. If Hb falls or does not respond, increase dose after ruling out other causes.
Iron status (serum ferritin, TSAT)
Frequency: Monthly or every 3 months, or as clinically indicated.
Target: Ferritin >100 ng/mL (CKD), >30 ng/mL (CIA); TSAT >20%.
Action Threshold: Supplement iron if levels are below target.
Blood Pressure (BP)
Frequency: Regularly, especially during initial therapy.
Target: Individualized, within patient's target BP.
Action Threshold: Manage hypertension aggressively; dose reduction or discontinuation may be needed if BP is difficult to control.
Renal function (BUN, creatinine, GFR)
Frequency: Periodically, as clinically indicated for CKD patients.
Target: Not applicable (monitoring for disease progression).
Action Threshold: Not applicable (monitoring for disease progression).
Symptom Monitoring
- Signs of uncontrolled hypertension (headache, blurred vision)
- Symptoms of thrombotic events (chest pain, shortness of breath, pain/swelling in leg, sudden weakness/numbness)
- Symptoms of allergic reactions (rash, itching, swelling, dizziness, trouble breathing)
- Symptoms of pure red cell aplasia (sudden worsening of anemia, fatigue, pallor)
Special Patient Groups
Pregnancy
Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. Animal studies have shown adverse effects on fetal development at doses higher than clinical doses. There are no adequate and well-controlled studies in pregnant women.
Trimester-Specific Risks:
First Trimester:
Potential for adverse developmental effects based on animal data.
Second Trimester:
Potential for adverse developmental effects based on animal data.
Third Trimester:
Potential for adverse developmental effects based on animal data.
Lactation
It is unknown whether darbepoetin alfa is excreted in human milk. Consider the developmental and health benefits of breastfeeding along with the mother's clinical need for Aranesp and any potential adverse effects on the breastfed infant from Aranesp or from the underlying maternal condition. Caution should be exercised.
Infant Risk:
L3 (Moderately Safe - No human data, animal data suggest risk or no data available; potential risk to infant cannot be ruled out).
Pediatric Use
Approved for anemia associated with CKD in pediatric patients 1 month to 16 years of age. Safety and efficacy in pediatric patients with chemotherapy-induced anemia have not been established. Dosing is weight-based and requires careful monitoring.
Geriatric Use
No overall differences in safety or efficacy were observed between elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out. Dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.
Clinical Information
Clinical Pearls
- Always ensure adequate iron stores before and during darbepoetin alfa therapy, as iron deficiency is the most common cause of blunted response.
- Monitor hemoglobin levels closely and adjust dose to avoid exceeding target ranges, especially 11 g/dL for CKD patients and 12 g/dL for CIA patients, due to increased risks of adverse cardiovascular events and mortality.
- Aggressively manage hypertension, as ESAs can cause or worsen high blood pressure.
- Patients should be educated on the signs and symptoms of blood clots and instructed to seek immediate medical attention if they occur.
- Darbepoetin alfa has a longer half-life than epoetin alfa, allowing for less frequent dosing (e.g., weekly or every 2-3 weeks).
Alternative Therapies
- Epoetin alfa (Epogen, Procrit, Retacrit)
- Methoxy polyethylene glycol-epoetin beta (Mircera)
- Blood transfusions (for acute, severe anemia or when ESAs are contraindicated/ineffective)
- Iron supplementation (oral or IV) for iron deficiency anemia, which may be used in conjunction with ESAs.
Cost & Coverage
Average Cost:
Varies widely by dose and pharmacy. For 60mcg/1ml, typically hundreds of dollars per vial. per vial
Insurance Coverage:
Specialty Tier (requires prior authorization, often subject to step therapy)
General Drug Facts
If your symptoms or health issues persist or worsen, it's essential to contact your doctor promptly. To ensure your safety, never share your medication with others or take someone else's medication. When you receive this medication, you will also get a Medication Guide, which is a detailed patient fact sheet. Please read this guide carefully and review it again whenever you refill your prescription. If you have any questions or concerns about this medication, don't hesitate to discuss them with your doctor, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. Be prepared to provide information about the overdose, including the medication taken, the amount, and the time it occurred.