Aranesp 300mcg/0.6ml Inj Alb Free
WARNING: This drug may raise the chance of heart attack, stroke, heart failure, blood clots, and death. Talk with the doctor.People with some types of cancer have died sooner when using this drug. This drug also raised the chance of tumor growth and the tumor happening again in these people. Talk with the doctor.Your doctor will need to watch your blood cell counts and follow you closely to change the dose to match your body's needs. Talk with your doctor. @ COMMON USES: It is used to treat anemia.
Drug Class
Erythropoiesis-stimulating agent (ESA)
Pharmacologic Class
Recombinant human erythropoietin analog
Pregnancy Category
Category C
FDA Approved
Nov 2001
DEA Schedule
Not Controlled
Overview
What is this medicine?
Darbepoetin alfa is a medicine that helps your body make more red blood cells. It's used when your body isn't making enough red blood cells, often due to kidney disease or certain cancer treatments. Having enough red blood cells helps carry oxygen throughout your body, reducing symptoms like tiredness and shortness of breath.
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 properly:
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 needle/sharp disposal box. Do not reuse needles or other items. When the disposal box is full, follow local regulations for proper 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 properly:
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 needle/sharp disposal box. Do not reuse needles or other items. When the disposal box is full, follow local regulations for proper 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
- It is very important to monitor your blood pressure regularly, as this medication can cause or worsen high blood pressure.
- Maintain adequate iron intake, as iron is essential for this medication to work effectively. Your doctor may prescribe iron supplements.
- Report any new or worsening symptoms immediately, especially severe headaches, vision changes, sudden numbness or weakness, chest pain, or shortness of breath.
- Do not shake the syringe, as this can damage the medication.
- 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:
CKD patients not on dialysis: Initial 0.45 mcg/kg IV or SC once every four weeks. 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. 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):
0.45 mcg/kg IV or SC once every four weeks
CKD (on dialysis):
0.45 mcg/kg IV or SC once weekly or 0.75 mcg/kg IV or SC once every two weeks
Chemotherapy-induced anemia:
2.25 mcg/kg SC once weekly or 500 mcg SC once every three weeks
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
CKD patients (1 month to 16 years): Initial 0.45 mcg/kg IV or SC once weekly or 0.75 mcg/kg IV or SC once every two weeks. Dose adjusted to maintain hemoglobin.
Adolescent:
CKD patients (1 month to 16 years): Initial 0.45 mcg/kg IV or SC once weekly or 0.75 mcg/kg IV or SC once every two weeks. Dose adjusted to maintain hemoglobin.
Dose Adjustments
Renal Impairment:
Mild:
No specific dose adjustment, dose titrated to hemoglobin target.
Moderate:
No specific dose adjustment, dose titrated to hemoglobin target.
Severe:
No specific dose adjustment, dose titrated to hemoglobin target.
Dialysis:
Dosing specified for patients on dialysis (0.45 mcg/kg IV or SC once weekly or 0.75 mcg/kg IV or SC once every two weeks). Hemoglobin target and iron status monitoring are critical.
Hepatic Impairment:
Mild:
No specific dose adjustment recommended.
Moderate:
No specific dose adjustment recommended.
Severe:
No specific dose adjustment recommended. Use with caution due to limited data.
Pharmacology
Mechanism of Action
Darbepoetin alfa is an erythropoiesis-stimulating agent (ESA) that stimulates erythropoiesis by the same mechanism as endogenous erythropoietin. It binds to erythropoietin receptors on erythroid progenitor cells, stimulating their proliferation and differentiation into mature red blood cells. Darbepoetin alfa has a longer half-life than epoetin alfa due to additional N-linked carbohydrate chains, which results in increased molecular weight and reduced renal clearance.
Pharmacokinetics
Absorption:
Bioavailability:
Approximately 37% (SC) to 54% (SC) in CKD patients; 49% (SC) in cancer patients.
Tmax:
Approximately 48 hours (SC) to 72 hours (SC).
FoodEffect:
Not applicable (administered parenterally).
Distribution:
Vd:
Approximately 0.06 L/kg (IV) to 0.07 L/kg (IV).
ProteinBinding:
Not extensively protein bound.
CnssPenetration:
Limited
Elimination:
HalfLife:
Approximately 21 hours (IV) to 49 hours (SC) in CKD patients; 27 hours (IV) to 70 hours (SC) in cancer patients.
Clearance:
Approximately 0.0015 L/hr/kg (IV) in CKD patients.
ExcretionRoute:
Primarily catabolism; minimal renal excretion of intact drug.
Unchanged:
Less than 10% (renal excretion of intact drug).
Pharmacodynamics
OnsetOfAction:
Increase in reticulocyte count typically observed within 7-10 days.
PeakEffect:
Hemoglobin levels typically begin to rise within 2-6 weeks, with peak effect varying based on dosing frequency.
DurationOfAction:
Due to its longer half-life, effects persist for several days to weeks, allowing for less frequent dosing (weekly, bi-weekly, or monthly).
Safety & Warnings
BLACK BOX WARNING
Increased Risk of Death, Serious Cardiovascular Events, Thromboembolic Events, and Stroke: 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. Increased Mortality and/or Tumor Progression in Cancer Patients: 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. The use of ESAs is not indicated for cancer patients receiving myelosuppressive chemotherapy when the anticipated outcome is cure. In cancer patients, discontinue darbepoetin alfa when the chemotherapy course is completed.
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 or seek immediate 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
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 called Stevens-Johnson syndrome or toxic epidermal necrolysis may occur. If you notice any of the following symptoms, seek medical help right away:
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. However, many people do not experience any side effects or only have mild ones. If you notice any of the following side effects or any other symptoms that bother you or do not go away, contact your doctor or seek medical help:
Stomach pain
Cough
This is not a comprehensive list of all 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 or seek immediate 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
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 called Stevens-Johnson syndrome or toxic epidermal necrolysis may occur. If you notice any of the following symptoms, seek medical help right away:
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. However, many people do not experience any side effects or only have mild ones. If you notice any of the following side effects or any other symptoms that bother you or do not go away, contact your doctor or seek medical help:
Stomach pain
Cough
This is not a comprehensive list of all 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 severe headache, confusion, problems with vision, speech, or balance (signs of stroke)
- Chest pain, shortness of breath, pain in arm or jaw (signs of heart attack)
- Swelling, pain, or redness in a leg (signs of blood clot)
- Sudden worsening of anemia (e.g., extreme fatigue, pallor, shortness of breath) that doesn't respond to treatment (possible pure red cell aplasia)
- Severe allergic reaction (rash, itching, hives, swelling of face/lips/tongue, difficulty breathing)
- Uncontrolled high blood pressure (severe headache, blurred vision, dizziness)
Before Using This Medicine
Before Taking This Medication: Important Information to Share with Your Doctor
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the symptoms you experienced.
If you have high blood pressure, as this may affect your treatment.
If you have been diagnosed with Pure Red Cell Aplasia (PRCA), a specific type of anemia.
If you have cancer, as this may impact your treatment plan. Discuss your condition with your doctor to determine the best course of action.
This list is not exhaustive, and it is crucial to disclose all your medications, including prescription and over-the-counter drugs, natural products, and vitamins, as well as any health problems you are experiencing. Your doctor and pharmacist need this information to ensure safe treatment. Never start, stop, or adjust the dosage of any medication without consulting your doctor first.
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the symptoms you experienced.
If you have high blood pressure, as this may affect your treatment.
If you have been diagnosed with Pure Red Cell Aplasia (PRCA), a specific type of anemia.
If you have cancer, as this may impact your treatment plan. Discuss your condition with your doctor to determine the best course of action.
This list is not exhaustive, and it is crucial to disclose all your medications, including prescription and over-the-counter drugs, natural products, and vitamins, as well as any health problems you are experiencing. Your doctor and pharmacist need this information to ensure safe treatment. Never start, stop, or adjust the dosage of any medication without consulting your doctor first.
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. 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 the amount recommended by your doctor, as this can increase the risk of severe side effects. If you accidentally take more than the prescribed 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, discuss them with your doctor.
If you are pregnant, planning to become pregnant, or breastfeeding, 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 the amount recommended by your doctor, as this can increase the risk of severe side effects. If you accidentally take more than the prescribed 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, discuss them with your doctor.
If you are pregnant, planning to become pregnant, or breastfeeding, 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, blood clots).
What to Do:
In case of overdose, contact a poison control center (1-800-222-1222) or seek emergency medical attention immediately. Management typically involves phlebotomy to reduce hemoglobin levels if polycythemia is severe, and supportive care for any associated complications.
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: To ensure adequate iron stores for optimal erythropoiesis. Iron deficiency is a common cause of resistance to ESAs.
Timing: Prior to and during therapy.
Blood pressure
Rationale: To establish baseline and identify pre-existing hypertension, which can be exacerbated by ESA therapy.
Timing: Prior to initiation of therapy.
Routine Monitoring
Hemoglobin (Hb)
Frequency: Weekly or bi-weekly until stable, then every 2-4 weeks.
Target: Individualized, generally 10-11 g/dL. Avoid exceeding 11 g/dL in CKD patients and 10 g/dL in cancer patients.
Action Threshold: If Hb increases by >1 g/dL in any 2-week period, or approaches/exceeds target range, reduce dose. If Hb falls below target, increase dose.
Blood pressure
Frequency: Regularly, especially during the initial phase of therapy.
Target: Individualized, maintain within patient's target range.
Action Threshold: If hypertension develops or worsens, initiate or intensify antihypertensive therapy. If BP remains uncontrolled, consider dose reduction or interruption of darbepoetin alfa.
Iron status (serum ferritin, TSAT)
Frequency: Monthly or quarterly, or as clinically indicated.
Target: Ferritin >100 ng/mL (CKD) or >200 ng/mL (CKD on dialysis); TSAT >20%.
Action Threshold: If iron deficiency is present, administer supplemental iron.
Renal function (BUN, creatinine)
Frequency: Periodically, as clinically indicated.
Target: Not applicable (monitor for changes).
Action Threshold: Monitor for any changes in renal function, especially in CKD patients.
Symptom Monitoring
- Symptoms of anemia (fatigue, shortness of breath, pallor)
- Symptoms of hypertension (headache, blurred vision, dizziness)
- Symptoms of thrombotic events (chest pain, shortness of breath, sudden numbness/weakness, vision changes, 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 (sudden worsening anemia, lack of response to therapy)
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 at doses higher than clinical 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 darbepoetin alfa 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 concern. Potential for adverse effects on the breastfed infant is possible; weigh benefits of drug to mother versus potential risks to infant.
Pediatric Use
Dosing for CKD-associated anemia is established for pediatric patients (1 month to 16 years). Safety and efficacy in pediatric patients with chemotherapy-induced anemia have not been established. Closely monitor hemoglobin and blood pressure.
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 adjustment is generally not required based on age alone, but careful monitoring for adverse events (e.g., cardiovascular events, hypertension) is prudent.
Clinical Information
Clinical Pearls
- Darbepoetin alfa has a longer half-life than epoetin alfa, allowing for less frequent dosing (weekly, bi-weekly, or monthly).
- 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 resistance.
- The primary goal of ESA therapy is to avoid red blood cell transfusions, not to normalize hemoglobin levels. Higher hemoglobin targets (above 11 g/dL in CKD or 10 g/dL in cancer) are associated with increased risks.
- Closely monitor blood pressure, as hypertension is a common side effect and can be severe.
- Patients should be educated on the signs and symptoms of thrombotic events (e.g., stroke, MI, DVT) and instructed 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 darbepoetin alfa and evaluate for anti-erythropoietin antibodies.
Alternative Therapies
- Epoetin alfa (Procrit, Epogen, Retacrit)
- Methoxy polyethylene glycol-epoetin beta (Mircera)
- Iron supplementation (oral or intravenous)
- Red blood cell transfusions (for acute, severe anemia)
Cost & Coverage
Average Cost:
$1,500 - $2,500+ per 300mcg/0.6ml prefilled syringe
Insurance Coverage:
Specialty Tier / Tier 4 (requires prior authorization, often subject to step therapy and quantity limits)
General Drug Facts
If your symptoms or health issues persist or worsen, it is essential to contact your doctor for further evaluation and guidance. 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 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 detailed information, including the name of the medication taken, the amount consumed, 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 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 detailed information, including the name of the medication taken, the amount consumed, and the time it occurred.