Aranesp 500mcg/ml Inj Alb 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
Oct 2001
DEA Schedule
Not Controlled
Overview
What is this medicine?
Darbepoetin alfa 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 chronic kidney disease or in some cancer patients 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 carefully:
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 carefully:
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
- Maintain a healthy diet, especially ensuring adequate iron intake (often requires iron supplements as prescribed by your doctor).
- Monitor your blood pressure regularly at home as instructed by your doctor.
- Report any unusual symptoms immediately, especially severe headaches, vision changes, chest pain, shortness of breath, or pain/swelling in your legs.
- Do not stop using this medication without talking 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 status. For CKD patients not on dialysis: Initial 0.45 mcg/kg IV or SC once every 4 weeks, or 0.75 mcg/kg IV or SC once every 2 weeks. 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, or 1.5 mcg/kg IV or SC once every 3 weeks, or 2.25 mcg/kg IV or SC once every 4 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 - 2.25 mg
Condition-Specific Dosing:
CKD (non-dialysis):
Initial 0.45 mcg/kg IV or SC once every 4 weeks, or 0.75 mcg/kg IV or SC once every 2 weeks. Adjust dose to maintain hemoglobin between 10-11 g/dL.
CKD (dialysis):
Initial 0.45 mcg/kg IV or SC once weekly, or 0.75 mcg/kg IV or SC once every 2 weeks, or 1.5 mcg/kg IV or SC once every 3 weeks, or 2.25 mcg/kg IV or SC once every 4 weeks. Adjust dose to maintain hemoglobin between 10-11 g/dL.
Chemotherapy-induced anemia:
Initial 2.25 mcg/kg SC once weekly, or 500 mcg SC once every 3 weeks. Discontinue if no response after 8 weeks of therapy or if chemotherapy is completed. Target hemoglobin should not exceed 10 g/dL.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
For CKD patients 1 month to 17 years: Initial 0.45 mcg/kg IV or SC once weekly, or 0.75 mcg/kg IV or SC once every 2 weeks. Adjust dose to maintain hemoglobin between 10-12 g/dL.
Adolescent:
For CKD patients 1 month to 17 years: Initial 0.45 mcg/kg IV or SC once weekly, or 0.75 mcg/kg IV or SC once every 2 weeks. Adjust dose to maintain hemoglobin between 10-12 g/dL.
Dose Adjustments
Renal Impairment:
Mild:
No specific dose adjustment; dosing is based on hemoglobin response in CKD patients.
Moderate:
No specific dose adjustment; dosing is based on hemoglobin response in CKD patients.
Severe:
No specific dose adjustment; dosing is based on hemoglobin response in CKD patients.
Dialysis:
Dosing regimens are specifically established for patients on dialysis (see adult dosing).
Hepatic Impairment:
Mild:
No specific dose adjustment recommended.
Moderate:
No specific dose adjustment recommended.
Severe:
No specific dose 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 its increased glycosylation, which results in more sialic acid residues.
Pharmacokinetics
Absorption:
Bioavailability:
Approximately 37% (SC in CKD patients), 49% (SC in cancer patients)
Tmax:
Subcutaneous: 48-72 hours (CKD), 71 hours (cancer)
FoodEffect:
Not applicable (parenteral administration)
Distribution:
Vd:
Approximately 0.06 L/kg (intravenous)
ProteinBinding:
Not extensively protein bound
CnssPenetration:
Limited
Elimination:
HalfLife:
Intravenous: Approximately 21 hours (CKD). Subcutaneous: Approximately 49 hours (CKD), 70 hours (cancer).
Clearance:
Approximately 0.0015 L/hr/kg (IV in CKD patients)
ExcretionRoute:
Primarily renal (small amount of intact drug), but mainly via cellular uptake and degradation.
Unchanged:
<10% (renal excretion of intact drug)
Pharmacodynamics
OnsetOfAction:
Increase in reticulocytes typically seen within 7-10 days.
PeakEffect:
Hemoglobin increase typically observed within 2-6 weeks.
DurationOfAction:
Due to its long half-life, effects persist for several weeks after the last dose, allowing for less frequent administration.
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. Aranesp is not indicated for patients with cancer receiving myelosuppressive chemotherapy when the anticipated outcome is cure. Discontinue Aranesp when chemotherapy is completed. Aranesp is not indicated for patients with cancer receiving myelosuppressive chemotherapy when the anticipated outcome is cure. Discontinue Aranesp when chemotherapy is completed.
Side Effects
Urgent Side Effects: Seek Medical Help Immediately
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 medical attention right away:
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 or changes in eyesight
Fast heartbeat
Shortness of breath, significant 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, or blurred vision
Confusion
Cool or pale arm or leg
Difficulty walking
Dizziness or fainting
Excessive sweating
Seizures
Feeling extremely tired or weak
Pale skin
If you experience any of the following symptoms, which may indicate a blood clot, seek medical help immediately:
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
In rare cases, a severe skin reaction (Stevens-Johnson syndrome/toxic epidermal necrolysis) may occur, which can cause serious health problems and potentially be life-threatening. Seek medical help right away 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 may cause side effects. While many people do not experience any side effects or only have mild ones, it is essential to discuss any concerns with your doctor. If you experience 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, consult 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 medical attention right away:
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 or changes in eyesight
Fast heartbeat
Shortness of breath, significant 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, or blurred vision
Confusion
Cool or pale arm or leg
Difficulty walking
Dizziness or fainting
Excessive sweating
Seizures
Feeling extremely tired or weak
Pale skin
If you experience any of the following symptoms, which may indicate a blood clot, seek medical help immediately:
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
In rare cases, a severe skin reaction (Stevens-Johnson syndrome/toxic epidermal necrolysis) may occur, which can cause serious health problems and potentially be life-threatening. Seek medical help right away 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 may cause side effects. While many people do not experience any side effects or only have mild ones, it is essential to discuss any concerns with your doctor. If you experience 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, consult 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 severe headache or vision changes
- Chest pain, shortness of breath, or pain/swelling in your leg (signs of blood clot)
- Sudden numbness or weakness, especially on one side of the body (signs of stroke)
- Signs of an allergic reaction (rash, itching, hives, swelling of face/lips/tongue, difficulty breathing)
- Unusual tiredness or weakness, or worsening of anemia symptoms (could indicate pure red cell aplasia)
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:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the symptoms you experienced.
If you have high blood pressure, as this may affect your treatment.
If you have been diagnosed with Pure Red Cell Aplasia (PRCA), a specific type of anemia.
If you have cancer, as this may impact your treatment plan. Discuss your condition 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 health problems you may have. Your doctor and pharmacist need this information to ensure safe treatment. Never start, stop, or adjust the dosage of any medication without first consulting your doctor to confirm it is safe to do so.
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the symptoms you experienced.
If you have high blood pressure, as this may affect your treatment.
If you have been diagnosed with Pure Red Cell Aplasia (PRCA), a specific type of anemia.
If you have cancer, as this may impact your treatment plan. Discuss your condition 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 health problems you may have. Your doctor and pharmacist need this information to ensure safe treatment. Never start, stop, or adjust the dosage of any medication without first consulting your doctor to confirm it is safe to do so.
Precautions & Cautions
It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. Before undergoing 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.
If you have a latex allergy, notify your doctor to ensure necessary precautions are taken. It is vital to take this medication only as directed by your doctor, as exceeding the prescribed dose can increase the risk of severe side effects. If you accidentally take more than the prescribed amount, 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, plan to become pregnant, or are breastfeeding, inform your doctor to discuss the potential benefits and risks to 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.
If you have a latex allergy, notify your doctor to ensure necessary precautions are taken. It is vital to take this medication only as directed by your doctor, as exceeding the prescribed dose can increase the risk of severe side effects. If you accidentally take more than the prescribed amount, 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, plan to become pregnant, or are breastfeeding, inform your doctor to discuss the potential benefits and risks to you and your baby.
Overdose Information
Overdose Symptoms:
- Polycythemia (excessively high red blood cell count)
- Symptoms related to increased blood viscosity (e.g., headache, dizziness, visual disturbances, hypertension, thrombotic events)
What to Do:
In case of overdose, contact a poison control center (1-800-222-1222) or seek emergency medical attention. Management typically involves phlebotomy to reduce hemoglobin and hematocrit levels, and supportive care for any associated complications (e.g., hypertension, thrombotic events).
Drug Interactions
Moderate Interactions
- Iron supplements (concurrent administration is often necessary to ensure adequate iron stores for erythropoiesis, but iron deficiency can limit darbepoetin alfa's effectiveness).
- Other erythropoiesis-stimulating agents (concurrent use is not recommended).
Monitoring
Baseline Monitoring
Hemoglobin (Hb)
Rationale: To establish baseline anemia severity and guide initial dosing.
Timing: Prior to initiation of therapy.
Iron status (serum ferritin, transferrin saturation [TSAT])
Rationale: To ensure adequate iron stores are available for erythropoiesis; iron deficiency can limit response to darbepoetin alfa.
Timing: Prior to initiation of therapy.
Blood Pressure (BP)
Rationale: To establish baseline and monitor for hypertension, a common adverse effect.
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 initially, then every 2-4 weeks once stable.
Target: CKD: 10-11 g/dL (do not exceed 11 g/dL). Chemotherapy-induced anemia: Do not exceed 10 g/dL.
Action Threshold: If Hb increases by >1 g/dL in any 2-week period or approaches target range, consider dose reduction. If Hb exceeds target, hold dose or reduce significantly.
Blood Pressure (BP)
Frequency: Regularly, especially during the initial phase of therapy.
Target: Individualized, within patient's target BP.
Action Threshold: If significant increase or new onset hypertension, manage aggressively with antihypertensives.
Iron status (serum ferritin, TSAT)
Frequency: Monthly or every 3 months, or as clinically indicated.
Target: Ferritin >100 ng/mL (CKD), TSAT >20% (CKD).
Action Threshold: If iron stores are low, initiate or increase iron supplementation.
Potassium
Frequency: Periodically, especially in CKD patients.
Target: Normal range.
Action Threshold: Monitor for hyperkalemia.
Symptom Monitoring
- Symptoms of anemia (fatigue, shortness of breath, pallor)
- Symptoms of hypertension (headache, dizziness, 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, severe dizziness, trouble breathing)
- Symptoms of pure red cell aplasia (sudden worsening of anemia, lack of response to darbepoetin alfa)
Special Patient Groups
Pregnancy
Category C. Animal studies have shown adverse effects on the fetus. Use only if the potential benefit justifies the potential risk to the fetus. It is not known if darbepoetin alfa can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity.
Trimester-Specific Risks:
First Trimester:
Potential for adverse effects based on animal data; human data limited.
Second Trimester:
Potential for adverse effects based on animal data; human data limited.
Third Trimester:
Potential for adverse effects based on animal data; human data limited.
Lactation
It is not known whether darbepoetin alfa is excreted in human milk. Caution should be exercised when darbepoetin alfa 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 risk - no human data, animal data suggest excretion into milk, potential for adverse effects on infant).
Pediatric Use
Approved for use in pediatric patients 1 month to 17 years with chronic kidney disease. Dosing is weight-based. Safety and efficacy in pediatric patients with chemotherapy-induced anemia have not been established.
Geriatric Use
No overall differences in safety or effectiveness were observed between patients ≥65 years of age and younger patients, but greater sensitivity of some older individuals cannot be ruled out. Older patients may be at higher risk for cardiovascular events and thrombotic events.
Clinical Information
Clinical Pearls
- Always assess iron status (ferritin and TSAT) before and during darbepoetin alfa therapy, as iron deficiency is the most common cause of ESA hyporesponsiveness. Iron supplementation is often required.
- Monitor hemoglobin closely. Do not exceed target hemoglobin levels (10-11 g/dL for CKD, 10 g/dL for CIA) due to increased risks of serious adverse events, including death, cardiovascular events, and tumor progression.
- Blood pressure must be well-controlled before initiating darbepoetin alfa and monitored closely during therapy, as hypertension is a common side effect.
- Patients should be educated on the signs and symptoms of thrombotic events and instructed to seek immediate medical attention if they occur.
- The 500 mcg/mL concentration is typically used for less frequent dosing regimens (e.g., once every 3 or 4 weeks) in patients who are stable on therapy.
Alternative Therapies
- Epoetin alfa (Epogen, Procrit, Retacrit)
- Methoxy polyethylene glycol-epoetin beta (Mircera)
- Iron supplementation (oral or intravenous)
- Red blood cell transfusions (for acute, severe anemia or when ESAs are contraindicated/ineffective)
Cost & Coverage
Average Cost:
Highly variable, typically several hundred to over a thousand USD per dose depending on strength and quantity. per prefilled syringe
Insurance Coverage:
Specialty Tier (requires prior authorization, often subject to step therapy and quantity limits)
General Drug Facts
If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. To ensure safe and effective treatment, never 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. It is vital to read this guide carefully and review it again whenever your prescription is refilled. If you have any questions or concerns about this medication, consult your doctor, pharmacist, or other healthcare provider for guidance.
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 detailed information, including the name of the medication taken, the quantity, and the time it occurred.
This medication is accompanied by a Medication Guide, which provides crucial information for patients. It is vital to read this guide carefully and review it again whenever your prescription is refilled. If you have any questions or concerns about this medication, consult your doctor, pharmacist, or other healthcare provider for guidance.
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 detailed information, including the name of the medication taken, the quantity, and the time it occurred.