Aranesp 100mcg 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
Hematopoietic agent
Pharmacologic Class
Erythropoiesis-stimulating agent (ESA)
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 to treat anemia (low red blood cell count) in people with kidney disease or certain types of cancer who are getting 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, and 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 sharps 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, and 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 sharps 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 adequate iron intake as prescribed by your doctor (often requires iron supplements).
- Monitor blood pressure regularly as instructed by your healthcare provider.
- Report any new or worsening symptoms immediately.
- Do not stop taking Aranesp without consulting your doctor.
- Keep all appointments for blood tests and doctor visits.
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 every four 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 two weeks. For chemotherapy-induced anemia: Initial 2.25 mcg/kg SC once weekly or 500 mcg SC once every three weeks.
Dose Range:
0.45 - 0.75 mg
Condition-Specific Dosing:
CKD_not_on_dialysis_initial:
0.45 mcg/kg IV or SC once every four weeks
CKD_on_dialysis_initial:
0.45 mcg/kg IV or SC once weekly or 0.75 mcg/kg IV or SC once every two weeks
Chemotherapy_induced_anemia_initial:
2.25 mcg/kg SC once weekly or 500 mcg SC once every three weeks
Hemoglobin_maintenance:
Adjust dose to maintain hemoglobin levels between 10-11 g/dL. Do not exceed 11 g/dL.
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. For chemotherapy-induced anemia: Not established.
Adolescent:
For CKD patients 1 month to 16 years: Initial 0.45 mcg/kg IV or SC once weekly. For chemotherapy-induced anemia: Not established.
Dose Adjustments
Renal Impairment:
Mild:
No specific dose adjustment required.
Moderate:
No specific dose adjustment required.
Severe:
Dosing as per standard CKD guidelines (on or not on dialysis).
Dialysis:
Dosing as per standard CKD on dialysis guidelines. Administer after dialysis session.
Hepatic Impairment:
Mild:
No specific dose adjustment required.
Moderate:
No specific dose adjustment required.
Severe:
No specific dose adjustment required, but 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 a longer circulating half-life and allows for less frequent dosing.
Pharmacokinetics
Absorption:
Bioavailability:
Approximately 37% (SC), 100% (IV)
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), 49 hours (SC) in CKD patients; approximately 27 hours (IV), 46 hours (SC) in cancer patients.
Clearance:
Approximately 0.02 ml/min/kg (IV)
ExcretionRoute:
Renal and hepatic
Unchanged:
Minimal renal excretion of unchanged drug
Pharmacodynamics
OnsetOfAction:
Increase in reticulocyte count typically within 7-10 days; increase in hemoglobin levels 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, and tumor progression or recurrence. To decrease these risks, use the lowest dose of Aranesp sufficient to avoid red blood cell transfusions. Do not exceed a hemoglobin level of 11 g/dL. For patients with cancer, ESAs shortened overall survival and/or increased the risk of tumor progression or recurrence in clinical studies. Aranesp is not indicated for patients with cancer receiving myelosuppressive chemotherapy when the anticipated outcome is cure.
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
+ 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 can cause side effects. While many people may not experience any side effects or only minor ones, it's 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
+ 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 can cause side effects. While many people may not experience any side effects or only minor ones, it's 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 chest pain or shortness of breath
- Sudden numbness or weakness on one side of your body
- Sudden severe headache or problems with vision or speech
- Swelling, pain, or redness in an arm or leg (signs of a blood clot)
- Uncontrolled high blood pressure
- Signs of an allergic reaction (rash, itching, hives, swelling of face/lips/tongue, difficulty breathing)
- Unusual tiredness or weakness (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 conditions before starting this medication:
If you have a known allergy to darbepoetin alfa or any component of this medication. Describe the allergic reaction and 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 this with your doctor to determine the best course of treatment.
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
* Existing health problems or medical conditions
Your doctor will assess this information to ensure it is safe for you to take this medication with your other drugs and health conditions. Do not initiate, stop, or modify the dose of any medication without first consulting 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 and 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 this with your doctor to determine the best course of treatment.
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
* Existing health problems or medical conditions
Your doctor will assess this information to ensure it is safe for you to take this medication with your other drugs and health conditions. Do not initiate, stop, or modify the dose of any medication without first consulting your doctor.
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 have surgery, consult with your doctor, as you may need to take an additional medication to prevent blood clots while using this drug.
Regular blood pressure monitoring is crucial, as this medication can cause high blood pressure. Follow your doctor's instructions for checking your blood pressure. Additionally, adhere to the schedule recommended by your doctor 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, plan to become pregnant, or are breastfeeding, inform your doctor. It is crucial to discuss the potential benefits and risks of this medication to both you and your baby to make an informed decision.
Regular blood pressure monitoring is crucial, as this medication can cause high blood pressure. Follow your doctor's instructions for checking your blood pressure. Additionally, adhere to the schedule recommended by your doctor 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, plan to become pregnant, or are breastfeeding, inform your doctor. It is crucial to discuss the potential benefits and risks of this medication to both you and your baby to make an informed decision.
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:
Call 1-800-222-1222 (Poison Control). Management typically involves phlebotomy to reduce hemoglobin levels and supportive care. Discontinuation of Aranesp until hemoglobin levels normalize.
Drug Interactions
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. 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.
Renal function (eGFR, BUN, creatinine)
Rationale: To assess kidney disease progression and guide dosing in CKD.
Timing: Prior to initiation and periodically.
Complete blood count (CBC) with differential
Rationale: To rule out other causes of anemia and monitor overall hematologic status.
Timing: Prior to initiation.
Routine Monitoring
Hemoglobin (Hb)
Frequency: Weekly until stable, then every 2-4 weeks.
Target: 10-11 g/dL (do not exceed 11 g/dL)
Action Threshold: If Hb increases by >1 g/dL in a 2-week period or approaches 11 g/dL, reduce dose by 25%. If Hb exceeds 11 g/dL, interrupt therapy until Hb falls below 10 g/dL, then restart at a reduced dose (25% less than previous dose).
Iron status (serum ferritin, TSAT)
Frequency: Monthly or quarterly, as clinically indicated.
Target: Ferritin >100 ng/mL (CKD), TSAT >20%
Action Threshold: Supplement iron if levels are below target.
Blood pressure
Frequency: Regularly (e.g., weekly to monthly).
Target: Individualized, controlled
Action Threshold: Manage hypertension aggressively; dose reduction or discontinuation may be necessary if hypertension is difficult to control.
Signs/symptoms of thrombotic events
Frequency: Ongoing
Target: N/A
Action Threshold: Prompt evaluation and management if symptoms occur.
Symptom Monitoring
- Fatigue
- Shortness of breath
- Dizziness
- Chest pain
- Swelling in legs or arms
- Sudden numbness or weakness on one side of the body
- Sudden severe headache
- Vision changes
- Signs of allergic reaction (rash, itching, hives, swelling, difficulty 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 on fetal development at doses higher than human therapeutic doses.
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 Aranesp is administered to a nursing woman. The decision to discontinue nursing or discontinue the drug should take into account the importance of the drug to the mother.
Infant Risk:
L3 (Moderate risk - no human data, but molecular weight suggests limited transfer; potential for adverse effects on infant erythropoiesis is theoretical).
Pediatric Use
Approved for anemia associated with CKD in pediatric patients 1 month to 16 years of age. Safety and efficacy for chemotherapy-induced anemia in pediatric patients have not been established. Dosing is weight-based.
Geriatric Use
No overall differences in safety or effectiveness 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.
Clinical Information
Clinical Pearls
- Always ensure adequate iron stores before and during Aranesp therapy, as iron deficiency is the most common cause of ESA hyporesponsiveness.
- Strictly adhere to the hemoglobin target of 10-11 g/dL. Doses should be reduced or held if hemoglobin approaches or exceeds 11 g/dL to mitigate serious cardiovascular and thrombotic risks.
- Monitor blood pressure closely, as hypertension is a common side effect and may require aggressive management.
- Administer Aranesp subcutaneously for most indications due to convenience and similar efficacy to IV, but IV is preferred for dialysis patients to ensure full dose delivery.
- Educate patients on the signs and symptoms of serious adverse events, especially blood clots and stroke, and to seek immediate medical attention if they occur.
- Pure red cell aplasia (PRCA) with neutralizing antibodies to erythropoietin has been reported, though rare. If PRCA is suspected, discontinue Aranesp and investigate for other causes.
Alternative Therapies
- Epoetin alfa (Epogen, Procrit, Retacrit)
- Methoxy polyethylene glycol-epoetin beta (Mircera)
- Iron supplementation (oral or IV)
- Red blood cell transfusions (for acute, severe anemia or when ESAs are contraindicated/ineffective)
Cost & Coverage
Average Cost:
Highly variable, typically several hundred to thousands of dollars per dose depending on strength and frequency. per 100mcg/1ml vial
Insurance Coverage:
Tier 3 or Specialty Tier (requires prior authorization, often subject to strict criteria)
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 important information for patients. Please read this guide carefully and review it again each time 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 amount, and the time it occurred.