Aranesp 60mcg/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
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's 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 vial, 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 materials. 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 for guidance on what to do next.
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 vial, 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 materials. 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 for guidance on what to do next.
Lifestyle & Tips
- Maintain adequate iron intake as advised by your doctor, as iron is crucial for Aranesp to work effectively.
- Monitor your blood pressure regularly as instructed by your healthcare provider, and report any significant changes.
- Attend all scheduled appointments for blood tests and follow-up care.
- Report any new or worsening symptoms immediately to 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. Typically administered subcutaneously (SC) or intravenously (IV).
Condition-Specific Dosing:
anemia_ckd_not_on_dialysis:
0.45 mcg/kg SC or IV once every 4 weeks, or 0.75 mcg/kg SC or IV once every 2 weeks, or 0.45 mcg/kg SC or IV once weekly. Target Hb 10-11 g/dL.
anemia_ckd_on_dialysis:
0.45 mcg/kg SC or IV once weekly, or 0.75 mcg/kg SC or IV once every 2 weeks, or 0.82 mcg/kg SC or IV once every 4 weeks. Target Hb 10-11 g/dL.
chemotherapy_induced_anemia:
2.25 mcg/kg SC once weekly, or 500 mcg SC once every 3 weeks. Discontinue when chemotherapy is completed or if Hb exceeds 12 g/dL.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Anemia associated with CKD: 0.45 mcg/kg SC or IV once weekly, or 0.75 mcg/kg SC or IV once every 2 weeks. Dosing for patients <18 years old on dialysis is 0.45 mcg/kg SC or IV once weekly. Dosing for patients <18 years old not on dialysis is 0.45 mcg/kg SC or IV once weekly or 0.75 mcg/kg SC or IV once every 2 weeks.
Adolescent:
Anemia associated with CKD: 0.45 mcg/kg SC or IV once weekly, or 0.75 mcg/kg SC or IV once every 2 weeks. Dosing for patients <18 years old on dialysis is 0.45 mcg/kg SC or IV once weekly. Dosing for patients <18 years old not on dialysis is 0.45 mcg/kg SC or IV once weekly or 0.75 mcg/kg SC or IV once every 2 weeks.
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.
Dialysis:
Dosing for CKD patients on dialysis is specified in adult/pediatric sections. Hemoglobin should be monitored closely.
Hepatic Impairment:
Mild:
No specific dose adjustment provided; use with caution.
Moderate:
No specific dose adjustment provided; use with caution.
Severe:
No specific dose adjustment provided; use with caution.
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 erythroid progenitor cells to stimulate red blood cell production. 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)
Tmax:
Approximately 48 hours (SC)
FoodEffect:
Not applicable (parenteral administration)
Distribution:
Vd:
Approximately 0.06 L/kg
ProteinBinding:
Not extensively protein bound
CnssPenetration:
Limited
Elimination:
HalfLife:
Approximately 21 hours (IV); Approximately 49 hours (SC)
Clearance:
Approximately 0.0024 L/hr/kg (IV)
ExcretionRoute:
Renal and hepatic clearance
Unchanged:
Minimal
Pharmacodynamics
OnsetOfAction:
Increase in reticulocytes typically observed within 7-10 days; increase in hemoglobin within 2-6 weeks.
PeakEffect:
Peak hemoglobin response typically seen after several weeks of therapy.
DurationOfAction:
Effects persist for several weeks after discontinuation due to long half-life.
Safety & Warnings
BLACK BOX WARNING
ESAs increase the risk of death, myocardial infarction, stroke, venous thromboembolism, thrombosis of vascular access, and tumor progression or recurrence. Use the lowest dose sufficient to avoid red blood cell transfusions. In patients with chronic kidney disease (CKD), ESAs increase the risk of death, serious cardiovascular events, and stroke. In patients with cancer, ESAs shorten overall survival and/or increase the risk of tumor progression or recurrence in some clinical studies. To decrease these risks, use the lowest dose needed 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
Confusion
Cool or pale arm or leg
Difficulty walking
Dizziness or fainting
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, changes in color, or pain in a leg or arm
Trouble speaking or swallowing
Severe Skin Reactions: Get Medical Help Right Away
In rare cases, this medication can cause a severe skin reaction known as Stevens-Johnson syndrome or toxic epidermal necrolysis. This condition can lead to severe health problems and even death. Seek immediate medical attention 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 Possible Side Effects
Like all medications, this drug can cause side effects. While many people may not experience any side effects or only minor ones, it's essential to contact your doctor or seek medical help if you notice any of the following:
Stomach pain
Cough
If you experience any side effects that bother you or do not go away, contact your doctor for advice. 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
Confusion
Cool or pale arm or leg
Difficulty walking
Dizziness or fainting
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, changes in color, or pain in a leg or arm
Trouble speaking or swallowing
Severe Skin Reactions: Get Medical Help Right Away
In rare cases, this medication can cause a severe skin reaction known as Stevens-Johnson syndrome or toxic epidermal necrolysis. This condition can lead to severe health problems and even death. Seek immediate medical attention 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 Possible Side Effects
Like all medications, this drug can cause side effects. While many people may not experience any side effects or only minor ones, it's essential to contact your doctor or seek medical help if you notice any of the following:
Stomach pain
Cough
If you experience any side effects that bother you or do not go away, contact your doctor for advice. 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 chest pain or shortness of breath
- Pain, swelling, warmth, or redness in an arm or leg (signs of a blood clot)
- Sudden numbness or weakness, especially on one side of the body
- Sudden severe headache, confusion, or problems with vision or speech (signs of stroke)
- Uncontrolled high blood pressure
- Seizures
- Severe allergic reaction (e.g., rash, hives, swelling of face/lips/tongue, difficulty breathing)
- Unusual tiredness or weakness, dizziness, or pale skin (signs of worsening anemia or PRCA)
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 medication. Describe the allergic reaction you experienced, including any symptoms.
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 this with your doctor to determine the best course of action.
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 currently taking
Any natural products or vitamins you are using
* Your complete medical history, including any health problems
Do not initiate, discontinue, or modify 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 medication. Describe the allergic reaction you experienced, including any symptoms.
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 this with your doctor to determine the best course of action.
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 currently taking
Any natural products or vitamins you are using
* Your complete medical history, including any health problems
Do not initiate, discontinue, or modify 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 additional 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 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 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 increased blood viscosity and thrombotic events (e.g., stroke, heart attack, blood clots).
What to Do:
Seek immediate medical attention. Management typically involves phlebotomy to reduce hemoglobin levels and supportive care. Call 1-800-222-1222 (Poison Control).
Drug Interactions
Monitoring
Baseline Monitoring
Hemoglobin (Hb)
Rationale: To establish baseline and guide initial dosing.
Timing: Prior to initiation of therapy.
Iron status (TSAT, ferritin)
Rationale: Adequate iron stores are essential for optimal response to ESAs. Iron supplementation may be required.
Timing: Prior to and during therapy.
Blood pressure
Rationale: ESAs can cause or exacerbate hypertension.
Timing: Prior to initiation and regularly during therapy.
Complete Blood Count (CBC) with differential
Rationale: To assess overall hematologic status and rule out other causes of anemia.
Timing: Prior to initiation.
Routine Monitoring
Hemoglobin (Hb)
Frequency: Weekly or bi-weekly until stable, then every 2-4 weeks.
Target: 10-11 g/dL (CKD); <12 g/dL (CIA)
Action Threshold: Adjust dose if Hb increases by >1 g/dL in 2 weeks, or if Hb exceeds target range. Withhold dose if Hb exceeds 11 g/dL (CKD) or 12 g/dL (CIA).
Blood pressure
Frequency: Regularly, especially during the initial phase of therapy.
Target: Individualized based on patient's clinical status.
Action Threshold: Manage hypertension aggressively; dose reduction or discontinuation may be necessary if hypertension is difficult to control.
Iron status (TSAT, ferritin)
Frequency: Monthly or quarterly, or as clinically indicated.
Target: TSAT >20%, Ferritin >100 ng/mL (CKD)
Action Threshold: Initiate or adjust iron supplementation if iron stores are inadequate.
Signs/symptoms of thrombotic events
Frequency: Ongoing
Target: N/A
Action Threshold: Prompt medical evaluation if symptoms occur.
Symptom Monitoring
- Headache
- Hypertension (new or worsening)
- Seizures
- Symptoms of blood clots (e.g., chest pain, shortness of breath, pain/swelling in leg, sudden numbness/weakness)
- Symptoms of allergic reaction (e.g., rash, hives, swelling, difficulty breathing)
- Symptoms of pure red cell aplasia (PRCA) (e.g., sudden worsening of anemia, fatigue, pallor)
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 observed in animal studies at high doses.
Second Trimester:
Potential for adverse developmental effects observed in animal studies at high doses.
Third Trimester:
Potential for adverse developmental effects observed in animal studies at high doses.
Lactation
It is not known whether darbepoetin alfa is excreted in human milk. Caution should be exercised when Aranesp is 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 concern - no human data, but large molecular weight suggests low transfer; potential for adverse effects on infant erythropoiesis is theoretical).
Pediatric Use
Approved for anemia associated with CKD in pediatric patients aged 1 month and older. Safety and efficacy in pediatric patients with chemotherapy-induced anemia have not been established. Dosing is weight-based and requires careful titration.
Geriatric Use
No overall differences in safety or effectiveness have been observed between elderly and younger patients. However, elderly patients may be more susceptible to cardiovascular events, and dose selection should be cautious, generally starting at the low end of the dosing range.
Clinical Information
Clinical Pearls
- Always ensure adequate iron stores (TSAT >20%, ferritin >100 ng/mL for CKD patients) before and during darbepoetin alfa therapy, as iron deficiency is the most common cause of ESA hyporesponsiveness.
- Do not exceed a hemoglobin level of 11 g/dL in CKD patients or 12 g/dL in CIA patients due to increased risks of serious adverse cardiovascular events and mortality.
- Monitor hemoglobin levels frequently (weekly or bi-weekly initially) and adjust dose no more frequently than once every 4 weeks.
- Aggressively manage hypertension, which is a common side effect and can be exacerbated by ESA therapy.
- Educate patients on the signs and symptoms of thrombotic events (e.g., DVT, PE, stroke, MI) and the importance of immediate medical attention if they occur.
- Pure Red Cell Aplasia (PRCA) with neutralizing antibodies to erythropoietin has been reported rarely. If PRCA is suspected, discontinue Aranesp and evaluate for anti-erythropoietin antibodies.
Alternative Therapies
- Epoetin alfa (Procrit, Epogen, Retacrit)
- Methoxy polyethylene glycol-epoetin beta (Mircera)
- Red blood cell transfusions (for acute, severe anemia or when ESAs are contraindicated/ineffective)
- Iron supplementation (oral or IV) for iron deficiency anemia
- Other agents for specific causes of anemia (e.g., vitamin B12, folate)
Cost & Coverage
Average Cost:
Varies widely based on dosage and quantity (e.g., $500 - $2000+) per vial/syringe
Insurance Coverage:
Tier 3 or Specialty Tier (requires prior authorization, step therapy)
General Drug Facts
If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. To ensure safe use, do not share your medication with others or take someone else's medication. This medication is accompanied by a Medication Guide, which provides crucial information for patients. Please read this guide carefully and review it again whenever you receive a refill of this medication. If you have any questions or concerns about this medication, consult 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. When reporting the incident, be prepared to provide details about the medication taken, the quantity, and the time it occurred.