Aranesp 200mcg/ml Vl Albumin Free
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
Nov 2001
DEA Schedule
Not Controlled
Overview
What is this medicine?
Aranesp is a medicine that helps your body make more red blood cells. It's used when your kidneys aren't making enough of a natural substance called erythropoietin, which can lead to anemia (low red blood cell count). By increasing red blood cells, it helps reduce the need for blood transfusions.
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 medication.
Do not use the medication if it has been shaken.
Do not use the medication if it has been frozen.
Wash your hands before and after handling the medication.
Inspect the solution before use; do not use if it is cloudy, leaking, or contains particles.
Do not use the medication if the solution has changed color.
* Avoid injecting into red or irritated skin.
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 medication.
Do not use the medication if it has been shaken.
Do not use the medication if it has been frozen.
Wash your hands before and after handling the medication.
Inspect the solution before use; do not use if it is cloudy, leaking, or contains particles.
Do not use the medication if the solution has changed color.
* Avoid injecting into red or irritated skin.
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
- Adhere strictly to the prescribed dosing schedule and administration route (IV or SC).
- Monitor blood pressure regularly at home as instructed by your doctor.
- Maintain adequate iron intake, often requiring iron supplements, as directed by your doctor.
- Report any new or worsening symptoms immediately to your healthcare provider.
- Do not shake the vial/syringe, as this can damage the protein.
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:
CKD Patients on Dialysis: Initial dose 0.45 mcg/kg IV or SC once weekly. CKD Patients Not on Dialysis: Initial dose 0.45 mcg/kg IV or SC once weekly, or 0.75 mcg/kg SC once every 2 weeks. Adjust dose to maintain hemoglobin levels between 10-11 g/dL.
Dose Range:
0.45 - 0.75 mg
Condition-Specific Dosing:
CKD (Dialysis):
Initial: 0.45 mcg/kg IV or SC once weekly. Maintenance: Adjust to maintain Hb 10-11 g/dL. May convert to once every 2 weeks (0.82 mcg/kg) or once monthly (1.6 mcg/kg) after stable.
CKD (Non-Dialysis):
Initial: 0.45 mcg/kg IV or SC once weekly, or 0.75 mcg/kg SC once every 2 weeks. Maintenance: Adjust to maintain Hb 10-11 g/dL. May convert to once monthly (2.25 mcg/kg) after stable.
Chemotherapy-Induced Anemia:
Initial: 2.25 mcg/kg SC once weekly, or 500 mcg SC once every 3 weeks. Adjust dose to maintain Hb 10-11 g/dL.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
CKD Patients (1 month to 17 years): Initial dose 0.45 mcg/kg IV or SC once weekly. Adjust dose to maintain hemoglobin levels between 10-11 g/dL.
Adolescent:
CKD Patients (1 month to 17 years): Initial dose 0.45 mcg/kg IV or SC once weekly. Adjust dose to maintain hemoglobin levels between 10-11 g/dL.
Dose Adjustments
Renal Impairment:
Mild:
No specific adjustment needed beyond standard CKD dosing protocols.
Moderate:
No specific adjustment needed beyond standard CKD dosing protocols.
Severe:
No specific adjustment needed beyond standard CKD dosing protocols (primary indication).
Dialysis:
Dosing specifically established for patients on dialysis (see adult/pediatric dosing).
Hepatic Impairment:
Mild:
No specific adjustment recommended.
Moderate:
No specific adjustment recommended.
Severe:
No specific adjustment recommended; 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 binds to erythropoietin receptors on erythroid progenitor cells, stimulating their proliferation and differentiation into mature red blood cells. Darbepoetin alfa has a longer half-life than epoetin alfa due to additional N-linked carbohydrate chains, allowing for less frequent dosing.
Pharmacokinetics
Absorption:
Bioavailability:
Approximately 37% (SC)
Tmax:
Approximately 48 hours (SC)
FoodEffect:
Not applicable (parenteral administration)
Distribution:
Vd:
Approximately 0.06 L/kg
ProteinBinding:
Limited
CnssPenetration:
Limited
Elimination:
HalfLife:
Approximately 49 hours (SC) in CKD patients; 21 hours (IV) in CKD patients.
Clearance:
Approximately 0.0015 L/hr/kg (IV)
ExcretionRoute:
Primarily catabolism; minimal renal excretion of intact drug.
Unchanged:
Less than 10% (renal)
Pharmacodynamics
OnsetOfAction:
Erythroid response typically observed within 2-6 weeks.
PeakEffect:
Hemoglobin levels typically begin to rise within 2-6 weeks, reaching target levels over several weeks to months with dose adjustments.
DurationOfAction:
Due to its long half-life, effects persist for several days to weeks, allowing for weekly, bi-weekly, or monthly dosing.
Confidence:
High
Safety & Warnings
BLACK BOX WARNING
ESAs increase the risk of death, myocardial infarction, stroke, venous thromboembolism, and thrombosis of vascular access. Target hemoglobin should not exceed 11 g/dL. In patients with cancer, ESAs shorten overall survival and/or increase the risk of tumor progression or recurrence in clinical studies. Use the lowest dose necessary to avoid red blood cell transfusions.
Side Effects
Urgent Side Effects: Seek Medical Help Right Away
Although rare, some people may experience severe and potentially life-threatening side effects while 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 Immediate Medical Attention
If you experience any of the following symptoms, which may indicate a blood clot, contact your doctor right away:
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: Stevens-Johnson Syndrome/Toxic Epidermal Necrolysis
This medication may cause a severe skin reaction, which can lead to serious health problems and even death. Seek immediate medical help if you notice:
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. Many people experience no side effects or only mild ones. However, if you notice any of the following side effects or any other symptoms that bother you or do not go away, contact your doctor:
Stomach pain
Cough
This is not an exhaustive list of possible side effects. If you have questions or concerns about side effects, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Although rare, some people may experience severe and potentially life-threatening side effects while 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 Immediate Medical Attention
If you experience any of the following symptoms, which may indicate a blood clot, contact your doctor right away:
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: Stevens-Johnson Syndrome/Toxic Epidermal Necrolysis
This medication may cause a severe skin reaction, which can lead to serious health problems and even death. Seek immediate medical help if you notice:
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. Many people experience no side effects or only mild ones. However, if you notice any of the following side effects or any other symptoms that bother you or do not go away, contact your doctor:
Stomach pain
Cough
This is not an exhaustive list of possible side effects. If you have questions or concerns about side effects, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Seek Immediate Medical Attention If You Experience:
- Sudden numbness or weakness, especially on one side of the body (signs of stroke)
- Sudden severe headache, confusion, problems with vision, speech, or balance (signs of stroke)
- Chest pain, shortness of breath, discomfort in the upper body (signs of heart attack)
- Swelling, pain, or redness in an arm or leg (signs of blood clot)
- Sudden increase in blood pressure, severe headache, blurred vision
- Signs of allergic reaction: rash, itching, hives, swelling of the face/lips/tongue, difficulty breathing
Before Using This Medicine
Before Taking This Medication: Important Information to Share with Your Doctor
It is essential to inform your doctor about the following conditions before starting this medication:
If you have a known allergy to darbepoetin alfa or any component of this drug. Describe your allergic reaction, including any symptoms you experienced.
If you have high blood pressure.
If you have been diagnosed with Pure Red Cell Aplasia (PRCA), a specific type of anemia.
If you have cancer, discuss your condition with your doctor.
Additionally, this medication may interact with other drugs or health conditions. Therefore, it is crucial to provide your doctor and pharmacist with a comprehensive list of:
All prescription and over-the-counter medications you are taking
Any natural products or vitamins you are using
* Your complete medical history, including any health problems
Do not start, stop, or adjust the dosage of any medication without first consulting your doctor to ensure safe use and minimize potential interactions.
It is essential to inform your doctor about the following conditions before starting this medication:
If you have a known allergy to darbepoetin alfa or any component of this drug. Describe your allergic reaction, including any symptoms you experienced.
If you have high blood pressure.
If you have been diagnosed with Pure Red Cell Aplasia (PRCA), a specific type of anemia.
If you have cancer, discuss your condition with your doctor.
Additionally, this medication may interact with other drugs or health conditions. Therefore, it is crucial to provide your doctor and pharmacist with a comprehensive list of:
All prescription and over-the-counter medications you are taking
Any natural products or vitamins you are using
* Your complete medical history, including any health problems
Do not start, stop, or adjust the dosage of any medication without first consulting your doctor to ensure safe use and minimize potential interactions.
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 checking your blood pressure. Additionally, follow your doctor's guidance for undergoing blood tests, 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 checking your blood pressure. Additionally, follow your doctor's guidance for undergoing blood tests, 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)
- Increased blood viscosity
- Increased risk of thrombotic events (e.g., stroke, heart attack, blood clots)
What to Do:
Seek immediate medical attention. Management typically involves phlebotomy to reduce red blood cell mass and supportive care. Call 1-800-222-1222 (Poison Control).
Drug Interactions
Monitoring
Baseline Monitoring
Hemoglobin (Hb)
Rationale: To establish baseline anemia severity and guide initial dosing.
Timing: Prior to initiation of therapy.
Iron Status (Ferritin, Transferrin Saturation (TSAT))
Rationale: To ensure adequate iron stores for optimal erythropoiesis; iron deficiency will limit response.
Timing: Prior to initiation of therapy.
Blood Pressure
Rationale: To establish baseline and identify pre-existing hypertension, as ESAs can cause or worsen hypertension.
Timing: Prior to initiation of therapy.
Complete Blood Count (CBC) with differential
Rationale: To rule out other causes of anemia and assess overall hematologic status.
Timing: Prior to initiation of therapy.
Routine Monitoring
Hemoglobin (Hb)
Frequency: Weekly or bi-weekly until stable, then monthly.
Target: 10-11 g/dL (do not exceed 11 g/dL)
Action Threshold: If Hb rises rapidly (>1 g/dL in 2 weeks) or exceeds 11 g/dL, reduce or interrupt dose. If Hb does not increase by 1 g/dL after 4 weeks of therapy, consider dose increase or evaluate for other causes of anemia.
Blood Pressure
Frequency: Regularly, especially during the initial phase of therapy and with dose changes.
Target: Individualized, typically <140/90 mmHg
Action Threshold: If significant increase in blood pressure or new onset hypertension, manage aggressively with antihypertensives or dose reduction/interruption of darbepoetin alfa.
Iron Status (Ferritin, TSAT)
Frequency: Monthly or every 3 months, or as clinically indicated.
Target: Ferritin >100 ng/mL (CKD non-dialysis) or >200 ng/mL (CKD dialysis); TSAT >20%
Action Threshold: If iron deficiency develops, administer supplemental iron.
Potassium
Frequency: Periodically, especially in CKD patients.
Target: 3.5-5.0 mEq/L
Action Threshold: Monitor for hyperkalemia, which can occur with ESA therapy.
Symptom Monitoring
- Signs/symptoms of thrombotic events (e.g., chest pain, shortness of breath, sudden numbness/weakness, vision changes, severe headache, swelling/pain in leg)
- Signs/symptoms of uncontrolled hypertension (e.g., severe headache, blurred vision, dizziness)
- Symptoms of anemia (e.g., fatigue, pallor, shortness of breath) to assess treatment response
- Signs of allergic reaction (e.g., rash, itching, swelling, severe dizziness, trouble breathing)
Special Patient Groups
Pregnancy
Category C. There are no adequate and well-controlled studies in pregnant women. Use only if the potential benefit justifies the potential risk to the fetus. Animal studies have shown adverse effects.
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 not known whether darbepoetin alfa is excreted in human milk. Caution should be exercised when administered to a nursing woman. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for Aranesp and any potential adverse effects on the breastfed child from Aranesp or from the underlying maternal condition.
Infant Risk:
L3 (Moderate risk - limited human data, potential for minor, non-serious adverse effects or no data; weigh benefits vs. risks).
Pediatric Use
Approved for use in pediatric patients (1 month to 17 years) with CKD-related anemia. Dosing is weight-based. Safety and efficacy have not been established in pediatric patients with chemotherapy-induced anemia.
Geriatric Use
No overall differences in safety or effectiveness were observed between geriatric and younger patients, but greater sensitivity of some older individuals cannot be ruled out. Dose adjustment is not typically required based on age alone, but monitor closely due to higher prevalence of comorbidities and polypharmacy.
Clinical Information
Clinical Pearls
- Always ensure adequate iron stores (ferritin >100-200 ng/mL, TSAT >20%) before and during darbepoetin alfa therapy, as iron deficiency is the most common cause of ESA hyporesponsiveness.
- The goal hemoglobin range is 10-11 g/dL. Doses should be adjusted to avoid exceeding 11 g/dL due to increased risks of cardiovascular events and mortality.
- Patients should be educated on the signs and symptoms of thrombotic events (e.g., stroke, MI, DVT) and uncontrolled hypertension, 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 (weekly, bi-weekly, or monthly).
- Do not shake the vial or syringe, as this can denature the glycoprotein and reduce its activity.
Alternative Therapies
- Red blood cell transfusions (for acute, severe anemia or when ESAs are contraindicated/ineffective)
- Iron supplementation (oral or intravenous, often used adjunctively with ESAs)
- Correction of underlying causes of anemia (e.g., nutritional deficiencies, bleeding, inflammation)
Cost & Coverage
Average Cost:
Highly variable, typically several hundred to thousands of dollars per dose depending on strength and frequency. per vial/syringe
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 for further guidance. To ensure your safety, never share your medication with others or take someone else's medication. This medication is accompanied by a Medication Guide, which provides crucial information. Please read this guide carefully and review it again whenever you receive a refill. If you have any questions or concerns about this medication, don't hesitate to consult with your doctor, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek medical attention. Be prepared to provide detailed information about the overdose, including the medication taken, the amount, and the time it occurred.