Aranesp 100mcg/0.5ml 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
Hematopoietic Agent
Pharmacologic Class
Erythropoiesis-Stimulating Agent (ESA)
Pregnancy Category
C
FDA Approved
Sep 2001
DEA Schedule
Not Controlled
Overview
What is this medicine?
Aranesp is a medicine that helps your body make more red blood cells. It's used to treat anemia (low red blood cell count) in people with kidney disease or certain types of cancer who are receiving chemotherapy. It works like a natural substance in your body called erythropoietin.
How to Use This Medicine
Proper Use of This Medication
To use this medication correctly, follow your doctor's instructions and read all provided information carefully. This medication is administered via injection into the fatty tissue under the skin or into a vein during dialysis. If you are self-administering the injection, your doctor or nurse will provide guidance on the proper technique.
Continue using this medication as directed by your doctor or healthcare provider, even if you are feeling well. It is essential to handle the medication correctly:
Do not shake the medication.
Do not use the medication if it has been shaken.
Do not use the medication if it has been frozen.
Wash your hands before and after handling the medication.
Inspect the solution before use; do not use if it is cloudy, leaking, or contains particles.
Do not use the medication if the solution has changed color.
* Avoid injecting into red or irritated skin.
After administering the dose, discard any remaining medication and dispose of the needle in a designated sharps container. Do not reuse needles or other 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 at all times. Do not freeze.
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 provided information carefully. This medication is administered via injection into the fatty tissue under the skin or into a vein during dialysis. If you are self-administering the injection, your doctor or nurse will provide guidance on the proper technique.
Continue using this medication as directed by your doctor or healthcare provider, even if you are feeling well. It is essential to handle the medication correctly:
Do not shake the medication.
Do not use the medication if it has been shaken.
Do not use the medication if it has been frozen.
Wash your hands before and after handling the medication.
Inspect the solution before use; do not use if it is cloudy, leaking, or contains particles.
Do not use the medication if the solution has changed color.
* Avoid injecting into red or irritated skin.
After administering the dose, discard any remaining medication and dispose of the needle in a designated sharps container. Do not reuse needles or other 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 at all times. Do not freeze.
Missed Dose
If you miss a dose, contact your doctor to determine the best course of action.
Lifestyle & Tips
- Maintain a healthy diet, especially ensuring adequate iron intake (as advised by your doctor).
- Monitor blood pressure regularly as instructed by your healthcare provider.
- Report any new or worsening symptoms immediately to your doctor.
- 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:
Varies by indication and route (SC or IV)
Condition-Specific Dosing:
anemia_ckd_not_on_dialysis:
0.45 mcg/kg SC or IV once every 4 weeks, or 0.75 mcg/kg SC or IV once every 2 weeks. Initial dose may be 0.45 mcg/kg SC or IV once weekly.
anemia_ckd_on_dialysis:
0.45 mcg/kg SC or IV once weekly, or 0.75 mcg/kg SC or IV once every 2 weeks, or 0.82 mcg/kg SC or IV once every 4 weeks. Initial dose may be 0.45 mcg/kg SC or IV once weekly.
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:
CKD (1 month to 17 years): 0.45 mcg/kg SC or IV once weekly, or 0.75 mcg/kg SC or IV once every 2 weeks. Initial dose may be 0.45 mcg/kg SC or IV once weekly.
Adolescent:
CKD (1 month to 17 years): 0.45 mcg/kg SC or IV once weekly, or 0.75 mcg/kg SC or IV once every 2 weeks. Initial dose may be 0.45 mcg/kg SC or IV once weekly.
Dose Adjustments
Renal Impairment:
Mild:
No specific dose adjustment needed, but monitor hemoglobin and adjust dose as per target range.
Moderate:
No specific dose adjustment needed, but monitor hemoglobin and adjust dose as per target range.
Severe:
No specific dose adjustment needed, but monitor hemoglobin and adjust dose as per target range.
Dialysis:
Dosing for CKD patients on dialysis is specified in adult/pediatric dosing. Monitor hemoglobin and iron status closely.
Hepatic Impairment:
Mild:
No specific dose adjustment needed.
Moderate:
No specific dose adjustment needed.
Severe:
No specific dose adjustment needed. Limited data available, use with caution.
Pharmacology
Mechanism of Action
Darbepoetin alfa is an erythropoiesis-stimulating agent (ESA). It is a recombinant human erythropoietin analog 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:
Approximately 37% (SC), 100% (IV)
Tmax:
Approximately 48 hours (SC)
FoodEffect:
Not applicable (parenteral administration)
Distribution:
Vd:
Approximately 0.06 L/kg
ProteinBinding:
Not extensively protein bound
CnssPenetration:
Limited
Elimination:
HalfLife:
Approximately 21 hours (IV), 49 hours (SC) in CKD patients; approximately 27 hours (IV), 46 hours (SC) in cancer patients.
Clearance:
Approximately 0.03 L/hr/kg (IV)
ExcretionRoute:
Primarily renal clearance, with some hepatic metabolism.
Unchanged:
Small amount excreted unchanged 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.
DurationOfAction:
Due to its long half-life, effects persist for several days to weeks after the last dose, allowing for less frequent administration.
Safety & Warnings
BLACK BOX WARNING
Increased risk of death, serious cardiovascular events, and stroke when ESAs are administered to target hemoglobin levels >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 Right Away
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor immediately or seek emergency medical attention:
Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin (with or without fever)
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of high blood pressure, including:
+ Severe headache or dizziness
+ Passing out
+ Changes in eyesight
Fast heartbeat
Shortness of breath
Sudden weight gain or swelling in the arms or legs
Weakness on one side of the body
Trouble speaking or thinking
Changes in balance
Drooping on one side of the face
Blurred eyesight
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 Medical Help Right Away
If you experience any of the following symptoms, which may indicate a blood clot, contact your doctor immediately:
Chest pain or pressure
Coughing up blood
Shortness of breath
Swelling, warmth, numbness, changes in color, or pain in a leg or arm
Trouble speaking or swallowing
Severe Skin 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. If you notice any of the following symptoms, seek medical attention immediately:
Red, swollen, blistered, or peeling skin (with or without fever)
Red or irritated eyes
Sores in your mouth, throat, nose, or eyes
Other Side Effects
Like all medications, this drug can cause side effects. While many people may not experience any side effects or only minor ones, it's essential to contact your doctor if you notice any of the following:
Stomach pain
Cough
If you experience any other side effects that bother you or do not go away, contact your doctor for advice. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor immediately or seek emergency medical attention:
Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin (with or without fever)
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of high blood pressure, including:
+ Severe headache or dizziness
+ Passing out
+ Changes in eyesight
Fast heartbeat
Shortness of breath
Sudden weight gain or swelling in the arms or legs
Weakness on one side of the body
Trouble speaking or thinking
Changes in balance
Drooping on one side of the face
Blurred eyesight
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 Medical Help Right Away
If you experience any of the following symptoms, which may indicate a blood clot, contact your doctor immediately:
Chest pain or pressure
Coughing up blood
Shortness of breath
Swelling, warmth, numbness, changes in color, or pain in a leg or arm
Trouble speaking or swallowing
Severe Skin 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. If you notice any of the following symptoms, seek medical attention immediately:
Red, swollen, blistered, or peeling skin (with or without fever)
Red or irritated eyes
Sores in your mouth, throat, nose, or eyes
Other Side Effects
Like all medications, this drug can cause side effects. While many people may not experience any side effects or only minor ones, it's essential to contact your doctor if you notice any of the following:
Stomach pain
Cough
If you experience any other side effects that bother you or do not go away, contact your doctor for advice. 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
- Sudden numbness or weakness on one side of the body
- Sudden severe headache or vision changes
- Swelling, pain, or redness in an arm or leg (signs of a blood clot)
- Unusual tiredness or weakness (could indicate worsening anemia or PRCA)
- Signs of an allergic reaction (rash, itching, hives, swelling of face/lips/tongue, difficulty breathing)
- Signs of 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 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 are experiencing. Your doctor and pharmacist need this information to ensure safe treatment. Never start, stop, or modify the dose of any medication without first consulting your doctor to confirm that it is safe to do so in conjunction with this medication.
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 are experiencing. Your doctor and pharmacist need this information to ensure safe treatment. Never start, stop, or modify the dose of any medication without first consulting your doctor to confirm that it is safe to do so in conjunction with this medication.
Precautions & Cautions
It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. Before undergoing surgery, consult with your doctor, as you may require an alternative medication to prevent blood clots while taking this drug.
Regular blood pressure checks are crucial, as this medication can cause high blood pressure. Adhere to your doctor's instructions for monitoring your blood pressure. Additionally, follow your doctor's guidance for scheduled blood work 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 can increase the risk of severe side effects. If you accidentally take more than the recommended dose, contact your doctor immediately.
This medication increases red blood cell production in the blood. Be aware that misuse or abuse of this type of medication can lead to severe health complications, including stroke, heart attack, and blood clots. If you have any questions or concerns, consult with your doctor.
If you are pregnant, plan to become pregnant, or are breastfeeding, inform your doctor to discuss the potential benefits and risks to you and your baby.
Regular blood pressure checks are crucial, as this medication can cause high blood pressure. Adhere to your doctor's instructions for monitoring your blood pressure. Additionally, follow your doctor's guidance for scheduled blood work 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 can increase the risk of severe side effects. If you accidentally take more than the recommended dose, contact your doctor immediately.
This medication increases red blood cell production in the blood. Be aware that misuse or abuse of this type of medication can lead to severe health complications, including stroke, heart attack, and blood clots. If you have any questions or concerns, consult with your doctor.
If you are pregnant, plan to become pregnant, or are breastfeeding, inform your doctor to discuss the potential benefits and risks to you and your baby.
Overdose Information
Overdose Symptoms:
- Polycythemia (excessively high red blood cell count), which can lead to increased blood viscosity and thrombotic events (e.g., stroke, heart attack, blood clots).
What to Do:
Contact your doctor or emergency services immediately. Management typically involves phlebotomy (blood removal) to reduce red blood cell count and supportive care. Call 1-800-222-1222 (Poison Control).
Drug Interactions
Monitoring
Baseline Monitoring
Hemoglobin (Hb)
Rationale: To establish baseline and guide initial dosing.
Timing: Before initiation of therapy.
Iron status (serum ferritin, transferrin saturation [TSAT])
Rationale: Iron deficiency limits response to ESAs. Ensure adequate iron stores before and during therapy.
Timing: Before initiation of therapy.
Blood pressure
Rationale: ESAs can cause or exacerbate hypertension.
Timing: Before initiation of therapy.
Complete Blood Count (CBC) with differential
Rationale: To rule out other causes of anemia and assess overall hematologic status.
Timing: Before initiation of therapy.
Routine Monitoring
Hemoglobin (Hb)
Frequency: Weekly or bi-weekly until stable, then every 2-4 weeks.
Target: CKD: 10-11 g/dL; Chemotherapy-induced anemia: Avoid exceeding 10 g/dL.
Action Threshold: If Hb rises rapidly (>1 g/dL in 2 weeks) or exceeds target, reduce dose. If Hb does not increase or falls, investigate for other causes of anemia (e.g., iron deficiency, inflammation, bleeding).
Iron status (serum 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 low.
Blood pressure
Frequency: Regularly, especially during the initial phase of therapy.
Target: Individualized, maintain within patient's target range.
Action Threshold: Manage hypertension aggressively; dose reduction or discontinuation may be necessary if hypertension is uncontrolled.
Symptom Monitoring
- Signs of thrombosis (e.g., chest pain, shortness of breath, sudden numbness or weakness, vision changes, swelling/pain in a limb)
- Signs of uncontrolled hypertension (e.g., severe headache, blurred vision, confusion)
- Symptoms of allergic reaction (e.g., rash, itching, hives, swelling, dizziness, trouble breathing)
- Symptoms of pure red cell aplasia (PRCA) (e.g., sudden worsening of anemia, fatigue, pallor)
- Signs of tumor progression (in cancer patients)
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, but there are no adequate and well-controlled studies in pregnant women.
Trimester-Specific Risks:
First Trimester:
Potential for adverse developmental effects based on animal data.
Second Trimester:
Potential for adverse developmental effects based on animal data.
Third Trimester:
Potential for adverse developmental effects based on animal data.
Lactation
It is not known whether darbepoetin alfa is excreted in human milk. Caution should be exercised when Aranesp is administered to a nursing woman. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for Aranesp and any potential adverse effects on the breastfed infant from Aranesp or from the underlying maternal condition.
Infant Risk:
L3 - Moderate risk. Weigh benefits vs. risks.
Pediatric Use
Approved for anemia associated with CKD in pediatric patients 1 month of age and older. Safety and efficacy in pediatric patients with chemotherapy-induced anemia have not been established.
Geriatric Use
No overall differences in safety or effectiveness have been 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
- Darbepoetin alfa has a longer half-life than epoetin alfa, allowing for less frequent dosing (e.g., weekly, bi-weekly, or monthly).
- Always ensure adequate iron stores (ferritin and TSAT) before and during ESA therapy, as iron deficiency is the most common cause of ESA hyporesponsiveness.
- Monitor hemoglobin levels closely and adjust the dose to avoid exceeding target ranges, especially 11 g/dL, due to increased risks of serious adverse events.
- Aggressively manage hypertension, which can be a common side effect of ESA therapy.
- Do not shake the prefilled syringe, as this can denature the protein.
- Inspect the solution for particulate matter or discoloration before administration; it should be clear and colorless.
Alternative Therapies
- Epoetin alfa (Procrit, Epogen)
- Methoxy polyethylene glycol-epoetin beta (Mircera)
- Iron supplementation (oral or IV)
- Red blood cell transfusions (for acute, severe anemia)
Cost & Coverage
Average Cost:
Varies significantly by dose and quantity (e.g., $500 - $5000+) per prefilled syringe
Insurance Coverage:
Tier 4 (Specialty Drug) or higher, often requires prior authorization and step therapy.
General Drug Facts
If your symptoms or health issues persist or worsen, it's essential to contact your doctor for further guidance. To ensure your safety, never share your medication with others or take someone else's medication.
This medication is accompanied by a Medication Guide, which provides crucial information about its use. Please read this guide carefully and review it again whenever you receive a refill of your medication. If you have any questions or concerns about this medication, don't hesitate 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. This information will help healthcare professionals provide you with the most effective treatment.
This medication is accompanied by a Medication Guide, which provides crucial information about its use. Please read this guide carefully and review it again whenever you receive a refill of your medication. If you have any questions or concerns about this medication, don't hesitate 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. This information will help healthcare professionals provide you with the most effective treatment.