Aranesp 60mcg/0.3ml Sgjct 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 when your body isn't making enough red blood cells on its own, often due to kidney disease or certain cancer treatments. It works like a natural substance in your body called erythropoietin.
How to Use This Medicine
Proper Use of This Medication
To use this medication correctly, follow your doctor's instructions and read all the information provided. This medication is administered via injection into the fatty tissue under the skin or into a vein during dialysis. If you are self-administering the injection, your doctor or nurse will provide guidance on the proper technique.
Continue using this medication as directed by your doctor or healthcare provider, even if you are feeling well. It is essential to handle the medication correctly: do not shake the vial, and do not use it if it has been shaken or frozen. Before and after use, wash your hands thoroughly.
Inspect the solution before use; do not use it if it appears cloudy, is leaking, contains particles, or has changed color. Avoid injecting into skin that is red or irritated. After administering the dose, discard any remaining medication and dispose of the needle in a designated sharps container. Do not reuse needles or other materials. When the container is full, follow local regulations for disposal. If you have any questions or concerns, consult your doctor or pharmacist.
Storage and Disposal
Store this medication in the refrigerator, but do not freeze it.
Missed Dose
If you miss a dose, contact your doctor 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 vial, and do not use it if it has been shaken or frozen. Before and after use, wash your hands thoroughly.
Inspect the solution before use; do not use it if it appears cloudy, is leaking, contains particles, or has changed color. Avoid injecting into skin that is red or irritated. After administering the dose, discard any remaining medication and dispose of the needle in a designated sharps container. Do not reuse needles or other materials. When the container is full, follow local regulations for disposal. If you have any questions or concerns, consult your doctor or pharmacist.
Storage and Disposal
Store this medication in the refrigerator, but do not freeze it.
Missed Dose
If you miss a dose, contact your doctor 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 at home, as this medication can increase blood pressure.
- Follow a healthy diet as recommended by 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 Anemia of Chronic Kidney Disease (CKD): Initial 0.45 mcg/kg IV or SC once weekly, or 0.75 mcg/kg SC once every 2 weeks. For Anemia of Chemotherapy-Induced Anemia (CIA): Initial 2.25 mcg/kg SC once weekly or 500 mcg SC once every 3 weeks. The 60mcg/0.3ml strength is a specific prefilled syringe dose that would be used as part of a titrated regimen.
Dose Range:
0.45 - 2.25 mg
Condition-Specific Dosing:
CKD (not on dialysis):
0.45 mcg/kg IV or SC once weekly, or 0.75 mcg/kg SC once every 2 weeks. Titrate to maintain hemoglobin (Hb) between 10-11 g/dL.
CKD (on dialysis):
0.45 mcg/kg IV or SC once weekly, or 0.75 mcg/kg SC once every 2 weeks. Titrate to maintain Hb between 10-11 g/dL.
Chemotherapy-Induced Anemia:
2.25 mcg/kg SC once weekly or 500 mcg SC once every 3 weeks. Discontinue when chemotherapy is completed.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
For Anemia of CKD (1 month to 17 years): Initial 0.45 mcg/kg IV or SC once weekly, or 0.75 mcg/kg SC once every 2 weeks. Titrate to maintain Hb between 10-12 g/dL.
Adolescent:
For Anemia of CKD (1 month to 17 years): Initial 0.45 mcg/kg IV or SC once weekly, or 0.75 mcg/kg SC once every 2 weeks. Titrate to maintain Hb between 10-12 g/dL.
Dose Adjustments
Renal Impairment:
Mild:
No specific dose adjustment needed, as the drug is used to treat anemia associated with CKD. Dosing is based on Hb response.
Moderate:
No specific dose adjustment needed, as the drug is used to treat anemia associated with CKD. Dosing is based on Hb response.
Severe:
No specific dose adjustment needed, as the drug is used to treat anemia associated with CKD. Dosing is based on Hb response.
Dialysis:
No specific dose adjustment needed for patients on dialysis; dosing is based on Hb response and route of administration (IV or SC).
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 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 increased glycosylation, allowing for less frequent dosing.
Pharmacokinetics
Absorption:
Bioavailability:
Subcutaneous: Approximately 37% (CKD patients), 54% (cancer patients)
Tmax:
Subcutaneous: Approximately 48 hours (CKD patients), 71 hours (cancer patients)
FoodEffect:
Not applicable (parenteral administration)
Distribution:
Vd:
Not extensively distributed into tissues; primarily confined to the vascular space.
ProteinBinding:
Not extensively protein bound.
CnssPenetration:
Limited
Elimination:
HalfLife:
Intravenous: Approximately 21 hours (CKD patients). Subcutaneous: Approximately 49 hours (CKD patients), 46 hours (cancer patients).
Clearance:
Clearance is primarily via receptor-mediated uptake and degradation.
ExcretionRoute:
Primarily catabolism; minimal renal excretion of intact drug.
Unchanged:
Less than 10% (renal excretion)
Pharmacodynamics
OnsetOfAction:
Increase in reticulocytes typically seen within 7-10 days; significant increase in hemoglobin usually within 2-6 weeks.
PeakEffect:
Peak hemoglobin effect is typically observed several weeks after initiation of therapy and dose stabilization.
DurationOfAction:
Due to its long half-life, effects persist for several days to weeks, allowing for weekly or bi-weekly dosing.
Safety & Warnings
BLACK BOX WARNING
Increased risk of death, serious cardiovascular and thromboembolic events, and stroke in patients with chronic kidney disease (CKD) when ESAs are administered to target hemoglobin levels of greater than 11 g/dL. Increased risk of tumor progression or recurrence in patients with cancer. Use the lowest dose sufficient to avoid red blood cell transfusions.
Side Effects
Urgent Side Effects: Seek Medical Help Immediately
While rare, some people may experience severe and potentially life-threatening side effects when 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 eyesight
Confusion
Cool or pale arm or leg
Difficulty walking
Dizziness or passing out
Excessive sweating
Seizures
Feeling extremely tired or weak
Pale skin
Signs of a blood clot, such as:
+ 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 (Stevens-Johnson syndrome/toxic epidermal necrolysis), which can cause:
+ Red, swollen, blistered, or peeling skin (with or without fever)
+ Red or irritated eyes
+ Sores in the mouth, throat, nose, or eyes
Other Possible Side Effects
Most people experience no side effects or only mild side effects when taking this medication. However, if you notice any of the following symptoms or any other unusual effects, contact your doctor or seek medical attention:
Stomach pain
* Cough
This is not an exhaustive list of possible side effects. If you have concerns or questions 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.
While rare, some people may experience severe and potentially life-threatening side effects when 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 eyesight
Confusion
Cool or pale arm or leg
Difficulty walking
Dizziness or passing out
Excessive sweating
Seizures
Feeling extremely tired or weak
Pale skin
Signs of a blood clot, such as:
+ 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 (Stevens-Johnson syndrome/toxic epidermal necrolysis), which can cause:
+ Red, swollen, blistered, or peeling skin (with or without fever)
+ Red or irritated eyes
+ Sores in the mouth, throat, nose, or eyes
Other Possible Side Effects
Most people experience no side effects or only mild side effects when taking this medication. However, if you notice any of the following symptoms or any other unusual effects, contact your doctor or seek medical attention:
Stomach pain
* Cough
This is not an exhaustive list of possible side effects. If you have concerns or questions 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 (signs of blood clot)
- Pain, swelling, warmth, or redness in an arm or leg (signs of blood clot)
- Sudden numbness or weakness, especially on one side of the body (signs of stroke)
- Sudden severe headache, confusion, or problems with vision or speech (signs of stroke or severe hypertension)
- Unusual tiredness or weakness, dizziness, or fainting (could indicate worsening anemia or other issues)
- Signs of an allergic reaction (rash, itching, hives, swelling of the face/lips/tongue/throat, difficulty breathing)
- Signs of pure red cell aplasia (PRCA), such as sudden worsening of anemia or no response to treatment.
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 allergic reaction you experienced, including any symptoms that occurred.
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 are experiencing. Your doctor and pharmacist need this information to ensure that it is safe for you to take this medication in conjunction with your other treatments. Never start, stop, or modify the dosage of any medication without first consulting your doctor to confirm that 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 allergic reaction you experienced, including any symptoms that occurred.
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 are experiencing. Your doctor and pharmacist need this information to ensure that it is safe for you to take this medication in conjunction with your other treatments. Never start, stop, or modify the dosage of any medication without first consulting your doctor to confirm that 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 have surgery, discuss this 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, have your blood work checked as directed by your doctor and discuss the results with them.
If you have a latex allergy, be sure to inform your doctor. It is also important to adhere to the prescribed dosage and not exceed it, as taking more than the recommended amount can increase the risk of severe side effects. If you accidentally take more of this medication than prescribed, 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 issues, including stroke, heart attack, and blood clots. If you have any questions or concerns, discuss them with your doctor.
If you are pregnant, planning to become pregnant, or are breast-feeding, inform your doctor. It is necessary to discuss the potential benefits and risks of this medication to both you and your baby.
Regular blood pressure monitoring is crucial, as this medication can cause high blood pressure. Follow your doctor's instructions for checking your blood pressure. Additionally, have your blood work checked as directed by your doctor and discuss the results with them.
If you have a latex allergy, be sure to inform your doctor. It is also important to adhere to the prescribed dosage and not exceed it, as taking more than the recommended amount can increase the risk of severe side effects. If you accidentally take more of this medication than prescribed, 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 issues, including stroke, heart attack, and blood clots. If you have any questions or concerns, discuss them with your doctor.
If you are pregnant, planning to become pregnant, or are breast-feeding, inform your doctor. It is necessary to discuss the potential benefits and risks of this medication to both you and your baby.
Overdose Information
Overdose Symptoms:
- Polycythemia (excessively high red blood cell count), which can lead to increased blood viscosity and thrombotic events (e.g., stroke, heart attack, deep vein thrombosis).
What to Do:
There is no specific antidote. Management should consist of supportive therapy aimed at reducing red blood cell count (e.g., phlebotomy) and managing complications. Call 1-800-222-1222 (Poison Control) or seek immediate medical attention.
Drug Interactions
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 optimal erythropoiesis and response to darbepoetin alfa. Iron supplementation may be required.
Timing: Prior to initiation of therapy.
Blood Pressure (BP)
Rationale: To establish baseline and identify pre-existing hypertension, which can be exacerbated by ESA therapy.
Timing: Prior to initiation of 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 of therapy.
Routine Monitoring
Hemoglobin (Hb)
Frequency: Weekly or bi-weekly until stable, then every 2-4 weeks.
Target: 10-11 g/dL (CKD); lowest Hb level to avoid transfusions (CIA). Avoid exceeding 11 g/dL (CKD) or 10 g/dL (CIA).
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, increase dose.
Blood Pressure (BP)
Frequency: Regularly, especially during the initial phase of therapy and dose adjustments.
Target: Individualized, maintain within patient's target range.
Action Threshold: If BP significantly increases or becomes difficult to control, consider dose reduction or discontinuation.
Iron status (Ferritin, TSAT)
Frequency: Monthly or every 3 months, or as clinically indicated.
Target: Ferritin >100 ng/mL (CKD), >200 ng/mL (CIA); TSAT >20%.
Action Threshold: If iron stores are low, initiate or increase iron supplementation.
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 numbness/weakness)
- Symptoms of allergic reactions (rash, itching, swelling, severe dizziness, trouble breathing)
- Symptoms of pure red cell aplasia (PRCA) (sudden worsening of anemia, lack of response to therapy)
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.
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 unknown 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 (Moderately Safe) - Limited human data suggest that it is unlikely to be excreted into milk in clinically significant amounts. However, caution is advised.
Pediatric Use
Approved for anemia of CKD in pediatric patients aged 1 month and older. 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 elderly and younger patients. However, elderly patients may have a higher incidence of comorbidities (e.g., cardiovascular disease) that may increase the risk of adverse events associated with ESA therapy. Dose selection should be cautious, generally starting at the low end of the dosing range.
Clinical Information
Clinical Pearls
- Always ensure adequate iron stores (ferritin and TSAT) before and during darbepoetin alfa therapy, as iron deficiency is the most common cause of treatment failure.
- Monitor hemoglobin levels closely and adjust dose to avoid exceeding target ranges, especially 11 g/dL in CKD patients, due to increased risks of cardiovascular events and mortality.
- Blood pressure must be well-controlled before initiating therapy and monitored frequently during treatment, as hypertension is a common side effect.
- Educate patients on the signs and symptoms of serious adverse events, particularly thrombotic events and severe hypertension, and when to seek immediate medical attention.
- Darbepoetin alfa has a longer half-life than epoetin alfa, allowing for less frequent dosing (e.g., weekly or bi-weekly vs. thrice weekly for epoetin alfa).
Alternative Therapies
- Epoetin alfa (e.g., Epogen, Procrit, Retacrit - biosimilar)
- Methoxy polyethylene glycol-epoetin beta (Mircera - another long-acting ESA)
- 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. per prefilled syringe
Insurance Coverage:
Tier 3 or 4 (Specialty Drug), often requires prior authorization and step therapy.
General Drug Facts
If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. To ensure safe use, 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, we encourage you to discuss them with 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.