Aranesp 100mcg Albumin-Free Inj
WARNING: This drug may raise the chance of heart attack, stroke, heart failure, blood clots, and death. Talk with the doctor.People with some types of cancer have died sooner when using this drug. This drug also raised the chance of tumor growth and the tumor happening again in these people. Talk with the doctor.Your doctor will need to watch your blood cell counts and follow you closely to change the dose to match your body's needs. Talk with your doctor. @ COMMON USES: It is used to treat anemia.
Drug Class
Hematopoietic Agent; Erythropoiesis-Stimulating Agent (ESA)
Pharmacologic Class
Recombinant Human Erythropoietin Analog
Pregnancy Category
C
FDA Approved
Sep 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 like a man-made version of a natural substance in your body called erythropoietin. It's used to treat anemia (low red blood cell count) in people with kidney disease or in some cancer patients receiving chemotherapy.
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 to determine the best course of action.
To use this medication correctly, follow your doctor's instructions and read all the information provided. This medication is administered via injection into the fatty tissue under the skin or into a vein during dialysis. If you are self-administering the injection, your doctor or nurse will provide guidance on the proper technique.
Continue using this medication as directed by your doctor or healthcare provider, even if you are feeling well. It is essential to handle the medication correctly: do not shake the container, and do not use it if it has been shaken or frozen. Before and after use, wash your hands thoroughly.
Inspect the solution before use; do not administer it if it appears cloudy, is leaking, contains particles, or has changed color. Avoid injecting into skin that is red or irritated. After administering the dose, discard any remaining medication and dispose of the needle in a designated sharps container. Do not reuse needles or other materials. When the sharps container is full, follow local regulations for disposal. If you have any questions or concerns, consult your doctor or pharmacist.
Storage and Disposal
Store this medication in the refrigerator, but do not freeze it.
Missed Dose
If you miss a dose, contact your doctor to determine the best course of action.
Lifestyle & Tips
- Maintain adequate iron intake as advised by your doctor, as iron is needed for darbepoetin alfa to work effectively.
- Monitor your blood pressure regularly at home as instructed by your doctor, and report any significant changes.
- Follow your doctor's instructions for diet and fluid intake, especially if you have kidney disease.
- Do not stop taking darbepoetin alfa without consulting your doctor, even if you feel better.
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 by indication and route (IV/SC). For CKD patients not on dialysis: Initial 0.45 mcg/kg IV or SC once every 4 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 2 weeks. For chemotherapy-induced anemia: Initial 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_not_on_dialysis:
Initial 0.45 mcg/kg IV or SC once every 4 weeks. Adjust dose to maintain hemoglobin between 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 2 weeks. Adjust dose to maintain hemoglobin between 10-11 g/dL.
Chemotherapy_induced_anemia:
Initial 2.25 mcg/kg SC once weekly or 500 mcg SC once every 3 weeks. Adjust dose to maintain hemoglobin at the lowest level sufficient to avoid red blood cell transfusion.
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. Adjust dose to maintain hemoglobin between 10-12 g/dL.
Adolescent:
CKD patients (1 month to 16 years): Initial 0.45 mcg/kg IV or SC once weekly. Adjust dose to maintain hemoglobin between 10-12 g/dL.
Dose Adjustments
Renal Impairment:
Mild:
No specific initial dose adjustment; dose titrated based on hemoglobin response.
Moderate:
No specific initial dose adjustment; dose titrated based on hemoglobin response.
Severe:
No specific initial dose adjustment; dose titrated based on hemoglobin response.
Dialysis:
Dosing for CKD patients on dialysis is specified in adult dosing. No additional adjustment beyond standard CKD dosing.
Hepatic Impairment:
Mild:
No specific dose adjustment recommended.
Moderate:
No specific dose adjustment recommended.
Severe:
No specific dose adjustment recommended. Use with caution; pharmacokinetics not well studied in severe hepatic impairment.
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 erythroid progenitor cells 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)
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 0.03 L/hr/kg (IV)
ExcretionRoute:
Primarily renal elimination of intact drug and metabolites.
Unchanged:
Minimal unchanged drug excreted in urine.
Pharmacodynamics
OnsetOfAction:
Increase in reticulocyte count typically seen within 7-10 days.
PeakEffect:
Hemoglobin levels typically begin to rise within 2-6 weeks, with peak effect varying based on individual response and dosing schedule.
DurationOfAction:
Due to its long half-life, effects persist for several weeks after the last dose, allowing for less frequent administration (e.g., once weekly, biweekly, or monthly).
Safety & Warnings
BLACK BOX WARNING
ESAs increase the risk of death, myocardial infarction, stroke, venous thromboembolism, and tumor progression or recurrence. To decrease these risks, use the lowest dose of Aranesp sufficient to avoid red blood cell transfusions. For patients with chronic kidney disease (CKD), do not exceed a hemoglobin level of 11 g/dL. For patients with cancer, Aranesp is not indicated for patients receiving myelosuppressive chemotherapy when the anticipated outcome is cure. Discontinue Aranesp 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
Blood Clots: Seek Immediate Medical Attention
If you experience any of the following symptoms, which may indicate a blood clot, contact your doctor right away:
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 Reactions: Seek Medical Help Right Away
In rare cases, this medication can cause a severe skin reaction known as Stevens-Johnson syndrome or toxic epidermal necrolysis. This condition can lead to severe health problems and even death. If you notice any of the following symptoms, seek immediate medical attention:
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 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, contact your doctor or seek medical help if they bother you or persist:
Stomach pain
Cough
Reporting 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
Blood Clots: Seek Immediate Medical Attention
If you experience any of the following symptoms, which may indicate a blood clot, contact your doctor right away:
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 Reactions: Seek Medical Help Right Away
In rare cases, this medication can cause a severe skin reaction known as Stevens-Johnson syndrome or toxic epidermal necrolysis. This condition can lead to severe health problems and even death. If you notice any of the following symptoms, seek immediate medical attention:
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 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, contact your doctor or seek medical help if they bother you or persist:
Stomach pain
Cough
Reporting 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 numbness or weakness on one side of the body
- Sudden severe headache
- Trouble speaking or understanding speech
- Vision changes
- Pain, swelling, warmth, or redness in an arm or leg (signs of a blood clot)
- Unusual tiredness or weakness
- Dizziness or lightheadedness
- Signs of an allergic reaction (rash, itching, hives, swelling of face/lips/tongue/throat, trouble 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:
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 cancer diagnosis 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 may have. Your doctor and pharmacist need this information to ensure safe treatment. Never start, stop, or change the dose 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 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 cancer diagnosis 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 may have. Your doctor and pharmacist need this information to ensure safe treatment. Never start, stop, or change the dose 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 regular blood work checks and discuss any concerns or questions with your doctor.
If you have a latex allergy, notify your doctor to ensure necessary precautions are taken. It is vital to take this medication only as directed by your doctor, as exceeding the prescribed dose may increase the risk of severe side effects. If you accidentally take more than the prescribed amount, 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 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. Adhere to your doctor's instructions for blood pressure checks. Additionally, follow your doctor's guidance for regular blood work checks and discuss any concerns or questions with your doctor.
If you have a latex allergy, notify your doctor to ensure necessary precautions are taken. It is vital to take this medication only as directed by your doctor, as exceeding the prescribed dose may increase the risk of severe side effects. If you accidentally take more than the prescribed amount, 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 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)
- Increased blood viscosity
- Increased risk of thrombotic events (e.g., stroke, myocardial infarction, deep vein thrombosis)
What to Do:
In case of overdose, contact a poison control center or emergency medical services immediately. Management typically involves phlebotomy to reduce hemoglobin and hematocrit levels, and supportive care for any associated complications (e.g., thrombotic events). 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 (Ferritin, Transferrin Saturation (TSAT))
Rationale: Adequate iron stores are essential for optimal response to ESAs. Iron supplementation may be required.
Timing: Prior to initiation of therapy.
Blood Pressure (BP)
Rationale: ESAs can cause or exacerbate hypertension.
Timing: Prior to initiation of therapy.
Complete Blood Count (CBC) with differential
Rationale: To rule out other causes of anemia and assess overall hematologic status.
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 level sufficient to avoid RBC transfusion (Chemotherapy-induced anemia).
Action Threshold: If Hb increases by >1 g/dL in 2 weeks or exceeds target range, reduce dose. If Hb does not increase by 1 g/dL after 4 weeks of therapy, increase dose. If Hb exceeds 11 g/dL (CKD) or 10 g/dL (Chemotherapy-induced anemia), hold or reduce dose.
Iron status (Ferritin, TSAT)
Frequency: Monthly or quarterly, or as clinically indicated.
Target: Ferritin >100 ng/mL (CKD), TSAT >20% (CKD).
Action Threshold: Supplement iron if levels are below target.
Blood Pressure (BP)
Frequency: Regularly, especially during the initial phase of therapy.
Target: Individualized, within normal limits.
Action Threshold: Manage hypertension aggressively; dose reduction or discontinuation of darbepoetin alfa may be necessary.
Renal function (SCr, eGFR)
Frequency: Periodically, as clinically indicated.
Target: Not applicable (monitoring for disease progression).
Action Threshold: Monitor for changes in renal function, though darbepoetin alfa is not known to directly worsen renal function.
Symptom Monitoring
- Signs of blood clot (e.g., chest pain, shortness of breath, pain/swelling in leg)
- Signs of stroke (e.g., sudden numbness/weakness, confusion, trouble speaking, vision changes)
- Signs of heart attack (e.g., chest pain, discomfort, shortness of breath, cold sweat)
- Signs of severe allergic reaction (e.g., rash, itching, swelling, severe dizziness, trouble breathing)
- Signs of worsening cancer (e.g., new lumps, unexplained weight loss, persistent pain)
- Symptoms of uncontrolled hypertension (e.g., severe headache, blurred vision, dizziness)
Special Patient Groups
Pregnancy
Category C. Use only if the potential benefit justifies the potential risk to the fetus. Animal studies have shown adverse effects on fetal development at doses higher than human therapeutic doses.
Trimester-Specific Risks:
First Trimester:
Potential for adverse developmental effects 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
L3 (Moderately safe). It is unknown whether darbepoetin alfa is excreted in human milk. Consider the developmental and health benefits of breastfeeding along with the mother’s clinical need for darbepoetin alfa and any potential adverse effects on the breastfed infant from darbepoetin alfa or from the underlying maternal condition.
Infant Risk:
Low to moderate risk. Due to its large molecular weight, absorption by the infant is unlikely. Monitor breastfed infants for adverse effects.
Pediatric Use
Approved for anemia associated with CKD in pediatric patients 1 month and older. Dosing is weight-based and adjusted to target hemoglobin levels. 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 be more sensitive to the effects of ESAs, particularly regarding cardiovascular events. Dose selection should be cautious, generally starting at the low end of the dosing range.
Clinical Information
Clinical Pearls
- Always assess iron status (ferritin and TSAT) before and during darbepoetin alfa therapy, as iron deficiency is the most common cause of ESA hyporesponsiveness.
- Darbepoetin alfa has a longer half-life than epoetin alfa, allowing for less frequent dosing (e.g., weekly, bi-weekly, or monthly).
- Strictly adhere to the hemoglobin target range (10-11 g/dL for CKD) to minimize the risk of serious adverse events, including cardiovascular events and stroke.
- Monitor blood pressure closely, especially at the initiation of therapy, as hypertension is a common side effect and may require aggressive management.
- Educate patients on the signs and symptoms of thrombotic events and the importance of reporting them immediately.
- For cancer patients, darbepoetin alfa is only indicated for chemotherapy-induced anemia when the anticipated outcome is not cure, and should be discontinued once chemotherapy is completed.
Alternative Therapies
- Epoetin alfa (Procrit, Epogen)
- Methoxy polyethylene glycol-epoetin beta (Mircera)
- Iron supplementation (oral or intravenous)
- Red blood cell transfusions (for acute, severe anemia or when ESA therapy is contraindicated/ineffective)
Cost & Coverage
Average Cost:
Not available per syringe
Insurance Coverage:
Tier 3 or 4 (Specialty drug), often requires 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 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 overdose, be prepared to provide details about the medication taken, the amount, and the time it occurred.