Aranesp 40mcg/ml Inj Srclk 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
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 long-term 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 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; 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 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 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; 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 for guidance on what to do next.
Lifestyle & Tips
- Keep all appointments for blood tests and doctor visits to monitor your hemoglobin and blood pressure.
- Take your blood pressure regularly at home as instructed by your doctor.
- Maintain adequate iron intake, as prescribed by your doctor, as iron is essential for red blood cell production.
- Report any new or worsening symptoms immediately to your healthcare provider.
- Do not stop taking Aranesp without consulting 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:
For Chronic Kidney Disease (CKD) patients on dialysis: Initial dose 0.45 mcg/kg IV or SC once weekly, or 0.75 mcg/kg IV or SC once every 2 weeks. For CKD patients not on dialysis: Initial dose 0.45 mcg/kg IV or SC once every 4 weeks. For Chemotherapy-Induced Anemia (CIA): Initial dose 2.25 mcg/kg SC once weekly, or 500 mcg SC once every 3 weeks.
Dose Range:
0.45 - 500 mg
Condition-Specific Dosing:
CKD (on dialysis):
Target hemoglobin 10-11 g/dL. Adjust dose to maintain hemoglobin within this range. Do not exceed 11 g/dL.
CKD (not on dialysis):
Target hemoglobin 10-11 g/dL. Adjust dose to maintain hemoglobin within this range. Do not exceed 11 g/dL.
Chemotherapy-Induced Anemia:
Target hemoglobin to avoid red blood cell transfusions. Do not exceed 12 g/dL. Discontinue if chemotherapy is completed or if no response after 8 weeks of therapy.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
For CKD patients (1 month to 16 years): Initial dose 0.45 mcg/kg IV or SC once weekly, or 0.75 mcg/kg IV or SC once every 2 weeks. Target hemoglobin 10-12 g/dL.
Adolescent:
Same as adult dosing for CKD patients (17 years and older).
Dose Adjustments
Renal Impairment:
Mild:
No specific dose adjustment required; dosing is based on hemoglobin response and target range.
Moderate:
No specific dose adjustment required; dosing is based on hemoglobin response and target range.
Severe:
No specific dose adjustment required; dosing is based on hemoglobin response and target range. Darbepoetin alfa is indicated for anemia associated with CKD.
Dialysis:
Dosing is specifically provided 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. Darbepoetin alfa is primarily catabolized, not extensively metabolized by the liver.
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 additional N-linked carbohydrate chains, allowing for less frequent dosing.
Pharmacokinetics
Absorption:
Bioavailability:
37% (SC, range 28-56%)
Tmax:
48 hours (SC)
FoodEffect:
Not applicable (administered parenterally)
Distribution:
Vd:
Approximately 0.06 L/kg
ProteinBinding:
Not extensively protein bound
CnssPenetration:
Limited
Elimination:
HalfLife:
IV: Approximately 21 hours; SC: Approximately 49 hours
Clearance:
Approximately 0.02 mL/min/kg (IV)
ExcretionRoute:
Primarily catabolism; minimal renal excretion of intact drug
Unchanged:
Less than 10% (renal)
Pharmacodynamics
OnsetOfAction:
Increase in reticulocyte count typically 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 and continued erythropoiesis.
Safety & Warnings
BLACK BOX WARNING
Increased risk of death, myocardial infarction, stroke, venous thromboembolism, thrombosis of vascular access, and tumor progression or recurrence. ESAs shorten overall survival and/or increase the risk of tumor progression or recurrence in patients with cancer. In patients with chronic kidney disease (CKD), ESAs increase the risk of death, serious cardiovascular events, and stroke. In patients with CKD, ESAs increase the risk of death, serious cardiovascular events, and stroke when administered to achieve hemoglobin levels greater than 11 g/dL. In patients with cancer receiving chemotherapy, ESAs increase the risk of death 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.
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: 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, or swelling of the mouth, face, lips, tongue, or throat
Signs of high blood pressure: severe headache, dizziness, fainting, or changes in vision
Rapid heartbeat
Shortness of breath, sudden weight gain, or swelling in the arms or legs
Weakness on one side of the body, difficulty speaking or thinking, balance problems, 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, color change, or pain in a leg or arm
Difficulty 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 even death. 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, 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 immediately or seek emergency medical attention:
Signs of an allergic reaction: 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, or swelling of the mouth, face, lips, tongue, or throat
Signs of high blood pressure: severe headache, dizziness, fainting, or changes in vision
Rapid heartbeat
Shortness of breath, sudden weight gain, or swelling in the arms or legs
Weakness on one side of the body, difficulty speaking or thinking, balance problems, 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, color change, or pain in a leg or arm
Difficulty 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 even death. 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, 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 (signs of heart attack or blood clot)
- Sudden numbness or weakness on one side of your body, sudden severe headache, or problems with vision or speech (signs of stroke)
- Swelling, pain, or redness in your arm or leg (signs of a blood clot)
- Unusual tiredness or dizziness, or worsening of anemia symptoms (may indicate lack of response or other issues)
- Headache, dizziness, or blurred vision (signs of high blood pressure)
- Signs of an allergic reaction (rash, itching, hives, swelling of face/lips/tongue, difficulty breathing)
Before Using This Medicine
Before Taking This Medication: Important Information to Share with Your Doctor
It is essential to inform your doctor about the following conditions before starting this medication:
If you have a known allergy to darbepoetin alfa or any component of this drug. Describe the allergic reaction and its symptoms to your doctor.
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
* 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 drug. Describe the allergic reaction and its symptoms to your doctor.
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
* 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 undergo 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. Adhere to your doctor's instructions for checking your blood pressure. Additionally, follow your doctor's guidance for having blood work checked 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 to make an informed decision.
Regular blood pressure monitoring is crucial, as this medication can cause high blood pressure. Adhere to your doctor's instructions for checking your blood pressure. Additionally, follow your doctor's guidance for having blood work checked 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 to make an informed decision.
Overdose Information
Overdose Symptoms:
- Polycythemia (excessively high red blood cell count), which can lead to serious cardiovascular events like stroke, heart attack, or blood clots.
What to Do:
In case of suspected overdose, seek immediate medical attention. Management typically involves phlebotomy (blood removal) to reduce hemoglobin levels and supportive care. Call 911 or your local emergency number. You can also call a poison control center at 1-800-222-1222.
Drug Interactions
Moderate Interactions
- Iron supplements (concurrent iron supplementation is often necessary to support 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 and guide initial dosing.
Timing: Prior to initiation of therapy.
Iron status (Ferritin, Transferrin Saturation (TSAT))
Rationale: To ensure adequate iron stores for effective 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.
Routine Monitoring
Hemoglobin (Hb)
Frequency: Weekly or bi-weekly until stable, then monthly.
Target: 10-11 g/dL (CKD); lowest Hb level sufficient to avoid transfusions (CIA, not to exceed 12 g/dL).
Action Threshold: If Hb increases by >1 g/dL in any 2-week period, or exceeds target range, reduce dose. If Hb does not increase by 1 g/dL after 4 weeks of therapy, consider increasing dose.
Blood Pressure (BP)
Frequency: Regularly (e.g., weekly or bi-weekly initially, then monthly or as clinically indicated).
Target: Individualized, based on patient's clinical status.
Action Threshold: If significant increase in BP or new onset hypertension, initiate or intensify antihypertensive therapy.
Iron status (Ferritin, TSAT)
Frequency: Monthly or every 3 months, or as clinically indicated.
Target: Ferritin >100 ng/mL and TSAT >20% (CKD).
Action Threshold: If iron deficiency develops, administer supplemental iron.
Renal function (BUN, Creatinine)
Frequency: Periodically, as clinically indicated.
Target: Not applicable (monitoring for underlying CKD progression).
Action Threshold: Not applicable (monitoring for underlying CKD progression).
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, weakness on one side of body, sudden severe headache, swelling/pain in leg)
- Symptoms of allergic reactions (rash, itching, hives, swelling of face/lips/tongue, difficulty breathing)
- Symptoms of pure red cell aplasia (PRCA) (sudden worsening of anemia, requiring transfusions)
Special Patient Groups
Pregnancy
Category C. There are no adequate and well-controlled studies in pregnant women. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. Animal studies have shown adverse effects at doses higher than human therapeutic doses.
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. Consider the developmental and health benefits of breastfeeding 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 - no human data, but large protein, likely low excretion into milk; potential for gastrointestinal degradation if ingested).
Pediatric Use
Darbepoetin alfa is approved for the treatment of anemia associated with CKD in pediatric patients 1 month of age and older. Dosing is weight-based. Safety and efficacy in pediatric patients with CIA have not been established.
Geriatric Use
No overall differences in safety or effectiveness have been observed between elderly and younger patients. Dose adjustment is generally not required based on age alone, but careful monitoring for adverse effects (especially cardiovascular events) is important due to higher prevalence of comorbidities in this population.
Clinical Information
Clinical Pearls
- Always ensure adequate iron stores (ferritin >100 ng/mL, TSAT >20%) before and during darbepoetin alfa therapy, as iron deficiency is the most common cause of ESA hyporesponsiveness.
- Monitor hemoglobin levels closely and adjust dose to avoid exceeding target ranges (especially 11 g/dL in CKD and 12 g/dL in CIA) due to increased risks of serious adverse events.
- Blood pressure must be well-controlled before and during therapy, as hypertension is a common and potentially serious side effect.
- Patients should be educated on the signs and symptoms of thrombotic events (e.g., DVT, PE, stroke, MI) and instructed to seek immediate medical attention if they occur.
- Darbepoetin alfa has a longer half-life than epoetin alfa, allowing for less frequent dosing (e.g., weekly, bi-weekly, or monthly), which can improve patient convenience and adherence.
- Do not shake the vial/syringe, as this can denature the glycoprotein and render it inactive.
Alternative Therapies
- Epoetin alfa (e.g., Epogen, Procrit, Retacrit - a biosimilar)
- 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 thousands of dollars per dose depending on strength and frequency. per vial/syringe
Insurance Coverage:
Specialty Tier (Tier 4 or higher) on most insurance plans, often requiring prior authorization.
General Drug Facts
If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. To ensure safe use, 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. 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 amount, and the time it occurred.