Aranesp 25mcg Inj, 0.42ml
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 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 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 items. 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 items. 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 adequate iron intake as prescribed by your doctor (often requires iron supplements).
- Monitor blood pressure regularly as instructed.
- Report any unusual symptoms immediately, especially chest pain, shortness of breath, sudden weakness or numbness, vision changes, or signs of a blood clot (e.g., pain, swelling, redness in a leg).
- Do not shake the syringe, as this can damage the medicine.
- Store in the refrigerator, protect from light, and do not freeze.
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 or 0.75 mcg/kg IV or SC once every two 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 3 weeks.
Condition-Specific Dosing:
CKD (not on dialysis):
Initial 0.45 mcg/kg IV or SC once every four weeks or 0.75 mcg/kg IV or SC once every two weeks. Target Hb 10-11 g/dL.
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. Target Hb 10-11 g/dL.
Chemotherapy-induced anemia:
Initial 2.25 mcg/kg SC once weekly or 500 mcg SC once every 3 weeks. Discontinue when chemotherapy course is completed.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
For CKD patients (≥1 month of age): Initial 0.45 mcg/kg IV or SC once weekly or 0.75 mcg/kg IV or SC once every two weeks. Dosing adjustments based on hemoglobin response.
Adolescent:
Same as adult dosing for CKD patients.
Dose Adjustments
Renal Impairment:
Mild:
No specific adjustment needed, but dose is based on weight and hemoglobin response.
Moderate:
No specific adjustment needed, but dose is based on weight and hemoglobin response.
Severe:
No specific adjustment needed, but dose is based on weight and hemoglobin response. Used to treat anemia in severe CKD.
Dialysis:
Used to treat anemia in dialysis patients. Dosing is adjusted based on hemoglobin response and iron status.
Hepatic Impairment:
Mild:
No specific adjustment recommended.
Moderate:
No specific adjustment recommended.
Severe:
No specific adjustment recommended.
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 (IV)
ProteinBinding:
Not extensively protein bound
CnssPenetration:
Limited
Elimination:
HalfLife:
Approximately 21 hours (IV), 49 hours (SC) in CKD patients; longer in healthy subjects.
Clearance:
Approximately 0.0024 L/hr/kg (IV)
ExcretionRoute:
Renal and hepatic clearance
Unchanged:
Minimal
Pharmacodynamics
OnsetOfAction:
Increase in reticulocyte count typically within 7-10 days; increase in hemoglobin within 2-6 weeks.
PeakEffect:
Peak hemoglobin effect typically observed after several weeks of therapy.
DurationOfAction:
Due to its long half-life, effects persist for several weeks after discontinuation, allowing for less frequent dosing (weekly, bi-weekly, or monthly).
Safety & Warnings
BLACK BOX WARNING
Increased mortality, myocardial infarction, stroke, and thromboembolism: ESAs increase the risk of death, myocardial infarction, stroke, venous thromboembolism, and thrombosis of vascular access. Use the lowest dose sufficient to avoid red blood cell transfusions. Cancer: ESAs shortened overall survival and/or increased the risk of tumor progression or recurrence in clinical studies of patients with breast, non-small cell lung, head and neck, lymphoid, and cervical cancers. To decrease these risks, as well as the risk of serious cardiovascular and thromboembolic reactions, use the lowest dose needed to avoid red blood cell transfusions. Discontinue Aranesp when chemotherapy is completed. Perisurgery: Aranesp is not approved for reduction of red blood cell transfusions in patients undergoing surgery.
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 immediately or seek emergency 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
Difficulty walking
Dizziness or passing out
Excessive sweating
Seizures
Feeling extremely tired or weak
Pale skin
Blood Clots: Seek Medical Help Right Away
If you experience any of the following symptoms, which may indicate a blood clot, contact your doctor immediately:
Chest pain or pressure
Coughing up blood
Shortness of breath
Swelling, warmth, numbness, changes in color, or pain in a leg or arm
Trouble speaking or swallowing
Severe Skin Reaction: Seek Medical Help Right Away
A severe skin reaction, known as Stevens-Johnson syndrome or toxic epidermal necrolysis, may occur. This condition can cause severe health problems and may be life-threatening. If you experience any of the following symptoms, seek medical help immediately:
Red, swollen, blistered, or peeling skin (with or without fever)
Red or irritated eyes
Sores in your mouth, throat, nose, or eyes
Other Side Effects
Like all medications, this drug may cause side effects. Many people experience no side effects or only mild ones. However, if you notice any of the following side effects or any other unusual symptoms, 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 immediately or seek emergency 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
Difficulty walking
Dizziness or passing out
Excessive sweating
Seizures
Feeling extremely tired or weak
Pale skin
Blood Clots: Seek Medical Help Right Away
If you experience any of the following symptoms, which may indicate a blood clot, contact your doctor immediately:
Chest pain or pressure
Coughing up blood
Shortness of breath
Swelling, warmth, numbness, changes in color, or pain in a leg or arm
Trouble speaking or swallowing
Severe Skin Reaction: Seek Medical Help Right Away
A severe skin reaction, known as Stevens-Johnson syndrome or toxic epidermal necrolysis, may occur. This condition can cause severe health problems and may be life-threatening. If you experience any of the following symptoms, seek medical help immediately:
Red, swollen, blistered, or peeling skin (with or without fever)
Red or irritated eyes
Sores in your mouth, throat, nose, or eyes
Other Side Effects
Like all medications, this drug may cause side effects. Many people experience no side effects or only mild ones. However, if you notice any of the following side effects or any other unusual symptoms, 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 chest pain or discomfort
- Shortness of breath
- Sudden weakness or numbness on one side of the body
- Sudden severe headache
- Problems with vision, speech, or balance
- Pain, swelling, warmth, or redness in an arm or leg (signs of a blood clot)
- Unusual tiredness or weakness (could indicate PRCA)
- Signs of an allergic reaction (e.g., rash, hives, swelling of face/lips/tongue, difficulty breathing)
- Worsening high blood pressure (e.g., severe headache, blurred vision)
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 as a result of the allergy.
If you have high blood pressure, as this may be relevant to 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. It is crucial to discuss your cancer diagnosis with your doctor.
This list is not exhaustive, and it is vital 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 it is safe for you to take this medication in conjunction with your other treatments. 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 as a result of the allergy.
If you have high blood pressure, as this may be relevant to 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. It is crucial to discuss your cancer diagnosis with your doctor.
This list is not exhaustive, and it is vital 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 it is safe for you to take this medication in conjunction with your other treatments. 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. 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.
If you have a latex allergy, notify your doctor to ensure your safety. 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 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 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 your safety. 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 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 to discuss the potential benefits and risks to you and your baby.
Overdose Information
Overdose Symptoms:
- Polycythemia (excessively high red blood cell count), which can lead to increased blood viscosity and risk of thromboembolic 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 (serum ferritin, transferrin saturation [TSAT])
Rationale: Adequate iron stores are essential for optimal response to ESAs. Iron deficiency can lead to ESA hyporesponsiveness.
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 and platelet count
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 monthly or as clinically indicated.
Target: 10-11 g/dL (individualized, generally not to exceed 11 g/dL).
Action Threshold: If Hb increases by >1 g/dL in any 2-week period or approaches 11 g/dL, dose reduction may be needed. If Hb exceeds 11 g/dL, hold or reduce dose. If Hb does not increase by 1 g/dL after 4 weeks of therapy, consider dose increase or investigate other causes of anemia.
Iron status (serum ferritin, TSAT)
Frequency: Monthly or every 3 months, or as clinically indicated.
Target: Ferritin >100 ng/mL (non-dialysis CKD) or >200 ng/mL (dialysis CKD); TSAT >20%.
Action Threshold: If iron stores are low, initiate or increase iron supplementation.
Blood pressure
Frequency: Regularly, especially during the initial phase of therapy.
Target: Individualized, based on patient's clinical status.
Action Threshold: If hypertension develops or worsens, initiate or intensify antihypertensive therapy.
Potassium
Frequency: Periodically, especially in CKD patients.
Target: Normal range.
Action Threshold: ESAs can cause hyperkalemia.
Symptom Monitoring
- Signs and symptoms of cardiovascular events (e.g., chest pain, shortness of breath, weakness, numbness, vision changes, slurred speech)
- Signs and symptoms of tumor progression or recurrence (in cancer patients)
- Signs and symptoms of allergic reactions (e.g., rash, urticaria, anaphylaxis)
- Signs and symptoms of Pure Red Cell Aplasia (PRCA) (e.g., sudden worsening of anemia, fatigue, pallor)
- Symptoms of hypertension (e.g., headache, dizziness, blurred vision)
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 doses higher than clinical exposure.
Second Trimester:
Potential for adverse developmental effects observed in animal studies at doses higher than clinical exposure.
Third Trimester:
Potential for adverse developmental effects observed in animal studies at doses higher than clinical exposure.
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 infant from Aranesp or from the underlying maternal condition.
Infant Risk:
L3 - Moderate risk. Weigh benefits vs. risks. Consider monitoring infant for adverse effects.
Pediatric Use
Approved for anemia associated with CKD in pediatric patients 1 month of age and older. Safety and efficacy in pediatric patients with chemotherapy-induced anemia have not been established. Dosing is weight-based and adjusted to hemoglobin response.
Geriatric Use
No overall differences in safety or effectiveness were observed between elderly and younger patients. However, elderly patients may be more sensitive to the effects of ESAs, particularly the cardiovascular and thromboembolic risks. Dose selection should be cautious, generally starting at the low end of the dosing range.
Clinical Information
Clinical Pearls
- Darbepoetin alfa has a longer half-life than epoetin alfa, allowing for less frequent dosing (e.g., weekly, bi-weekly, or monthly).
- Always ensure adequate iron stores (ferritin and TSAT) before and during ESA therapy, as iron deficiency is a common cause of ESA hyporesponsiveness.
- Do NOT target hemoglobin levels above 11 g/dL due to increased risks of serious cardiovascular events, stroke, and mortality, especially in CKD patients.
- In cancer patients, discontinue Aranesp once the chemotherapy course is completed.
- Closely monitor blood pressure, as hypertension is a common side effect and can be severe.
- Educate patients on the signs and symptoms of blood clots and stroke, and to seek immediate medical attention if they occur.
Alternative Therapies
- Epoetin alfa (Epogen, Procrit, Retacrit, etc.)
- 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 prefilled syringe
Insurance Coverage:
Tier 3 or Specialty Tier (requires prior authorization and often 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 and effective treatment, never share your medication with others or take someone else's medication.
This medication is accompanied by a Medication Guide, a patient fact sheet that provides crucial information. 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.
In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. Be prepared to provide detailed information about the overdose, including the medication taken, the amount, and the time it occurred.
This medication is accompanied by a Medication Guide, a patient fact sheet that provides crucial information. 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.
In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. Be prepared to provide detailed information about the overdose, including the medication taken, the amount, and the time it occurred.