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Aranesp 40mcg/ml Vl Albumin Free

Manufacturer AMGEN Active Ingredient Darbepoetin Alfa Vials(dar be POE e tin AL fa) Pronunciation dar-be-POE-e-tin AL-fa
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.
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Drug Class
Erythropoiesis-Stimulating Agent (ESA)
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Pharmacologic Class
Recombinant Human Erythropoietin Analog
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Pregnancy Category
Category C
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FDA Approved
Nov 2001
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DEA Schedule
Not Controlled

Overview

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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. It works like a natural substance in your body called erythropoietin.
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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, and 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 container 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 for guidance on what to do next.
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Lifestyle & Tips

  • Take exactly as prescribed; do not miss doses.
  • Keep all appointments for blood tests and blood pressure checks.
  • Report any new or worsening symptoms immediately to your doctor.
  • Maintain adequate iron intake as advised by your doctor (often requires iron supplements).
  • Monitor blood pressure regularly at home if advised by your doctor.
  • Do not shake the vial/syringe; shaking can damage the protein.
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Available Forms & Alternatives

Available Strengths:

Dosing & Administration

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Adult Dosing

Standard Dose: Varies significantly by indication and patient response.

Condition-Specific Dosing:

CKD-related anemia (non-dialysis): 0.45 mcg/kg IV or SC once every 4 weeks, or 0.75 mcg/kg IV or SC once every 2 weeks. Titrate to maintain Hb between 10-11 g/dL.
CKD-related anemia (dialysis): 0.45 mcg/kg IV or SC once weekly, or 0.75 mcg/kg IV or SC once every 2 weeks, or 1.5 mcg/kg IV or SC once every 3 weeks, or 2.25 mcg/kg IV or SC once every 4 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 course is completed.
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Pediatric Dosing

Neonatal: Not established
Infant: Not established
Child: CKD-related anemia (1 month to <18 years): 0.45 mcg/kg IV or SC once weekly, or 0.75 mcg/kg IV or SC once every 2 weeks. Titrate to maintain Hb between 10-12 g/dL.
Adolescent: CKD-related anemia (1 month to <18 years): 0.45 mcg/kg IV or SC once weekly, or 0.75 mcg/kg IV or SC once every 2 weeks. Titrate to maintain Hb between 10-12 g/dL.
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Dose Adjustments

Renal Impairment:

Mild: No specific dose adjustment; dose based on hemoglobin response.
Moderate: No specific dose adjustment; dose based on hemoglobin response.
Severe: No specific dose adjustment; dose based on hemoglobin response (primary indication for use).
Dialysis: Dosing adjusted based on hemoglobin response and target range (see adult dosing).

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

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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.
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Pharmacokinetics

Absorption:

Bioavailability: Approximately 37% (SC) to 54% (SC) in healthy subjects; higher in CKD patients (SC bioavailability 49-62%).
Tmax: Approximately 48 hours (SC) to 72 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) to 49 hours (SC) in CKD patients; 73 hours (SC) in healthy subjects.
Clearance: Approximately 0.03 L/hr/kg (IV) in CKD patients.
ExcretionRoute: Primarily catabolism; minimal renal excretion of intact drug.
Unchanged: Less than 10% (renal excretion)
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Pharmacodynamics

OnsetOfAction: Increase in reticulocytes typically observed within 7-10 days.
PeakEffect: Peak hemoglobin response typically seen within 2-6 weeks.
DurationOfAction: Effects on erythropoiesis persist for several weeks after the last dose due to the long half-life and the lifespan of red blood cells.

Safety & Warnings

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BLACK BOX WARNING

Increased risk of death, myocardial infarction, stroke, venous thromboembolism, and tumor progression or recurrence. Use the lowest dose sufficient to avoid red blood cell transfusions. For patients with chronic kidney disease (CKD), the target hemoglobin should not exceed 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. Aranesp is not indicated for patients with cancer receiving hormonal agents, biologic products, or radiotherapy, unless also receiving concomitant myelosuppressive chemotherapy.
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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
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
Feeling confused
 Cool or pale arm or leg
Trouble walking
 Dizziness or passing out
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, change of color, or pain in a leg or arm
Trouble speaking or swallowing

Severe Skin Reaction: Stevens-Johnson Syndrome/Toxic Epidermal Necrolysis

In rare cases, this medication may cause a severe skin reaction, which can lead to serious health problems and even death. Seek medical help immediately if you experience:

 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

Most people do not experience severe side effects, and some may have only minor side effects. However, if you notice any of the following side effects or any other unusual symptoms, contact your doctor or seek medical attention:

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.
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Seek Immediate Medical Attention If You Experience:

  • Chest pain, shortness of breath, sudden numbness or weakness on one side of the body, problems with vision or speech (signs of blood clots or stroke)
  • Severe headache, confusion, seizures, blurred vision (signs of severe high blood pressure)
  • Swelling of the face, lips, tongue, or throat, difficulty breathing, rash, hives (signs of severe allergic reaction)
  • Unusual tiredness, dizziness, pale skin, worsening shortness of breath (signs of worsening anemia or pure red cell aplasia)
  • Pain or swelling in your leg (signs of deep vein thrombosis)
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Before Using This Medicine

Before Taking This Medication: Important Information to Share with Your Doctor

It is essential to inform your doctor about the following conditions before starting this medication:

If you have a known allergy to darbepoetin alfa or any component of this drug. Describe the allergic reaction and symptoms you experienced.
 If you have high blood pressure.
If you have been diagnosed with Pure Red Cell Aplasia (PRCA), a specific type of anemia.
 If you have cancer, discuss this with your doctor to determine the best course of action.

Additionally, this medication may interact with other drugs or health conditions. Therefore, it is crucial to provide your doctor and pharmacist with a comprehensive list of:

All prescription and over-the-counter (OTC) medications you are currently taking.
 Any natural products or vitamins you are using.
* Your complete medical history, including any health problems.

Do not initiate, discontinue, or modify the dosage of any medication without first consulting your doctor to ensure safe use and minimize potential interactions.
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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, discuss this with your doctor, as you may need to take 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 checking your blood pressure. Additionally, follow your doctor's guidance for having blood work checked and discuss any concerns or questions with your doctor.

To minimize the risk of severe side effects, do not exceed the dosage prescribed by your doctor. If you accidentally take more than the recommended dose, contact your doctor immediately.

This medication increases red blood cell production in the blood. Be aware that misuse or abuse of this type of medication can lead to severe health complications, including stroke, heart attack, and blood clots. If you have any questions or concerns, consult your doctor.

If you are pregnant, plan to become pregnant, or are breastfeeding, inform your doctor. It is crucial to discuss the potential benefits and risks of this medication to both you and your baby.
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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:

Seek immediate medical attention. Management typically involves phlebotomy to reduce red blood cell mass and supportive care. Call 1-800-222-1222 (Poison Control).

Drug Interactions

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Moderate Interactions

  • Iron supplements (may be needed to support erythropoiesis, but not a direct interaction)
  • Blood pressure medications (monitor blood pressure closely, as ESAs can cause or worsen hypertension)

Monitoring

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Baseline Monitoring

Hemoglobin (Hb)

Rationale: To establish baseline anemia severity and guide initial dosing.

Timing: Prior to initiation of therapy.

Iron status (TSAT, ferritin)

Rationale: To ensure adequate iron stores for optimal erythropoiesis; iron deficiency can lead to resistance to ESA therapy.

Timing: Prior to initiation of 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.

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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.

Action Threshold: If Hb rises rapidly (>1 g/dL in 2 weeks) or exceeds target range, reduce dose or interrupt therapy.

Blood pressure

Frequency: Regularly, especially during the initial phase of therapy and dose adjustments.

Target: Individualized, based on patient's clinical status.

Action Threshold: If significant increase or uncontrolled hypertension, manage aggressively.

Iron status (TSAT, ferritin)

Frequency: Monthly or every 3 months, or as clinically indicated.

Target: TSAT ≥20%, Ferritin ≥100 ng/mL (CKD).

Action Threshold: If iron deficiency, initiate or increase iron supplementation.

Renal function (BUN, creatinine)

Frequency: Periodically, as clinically indicated.

Target: Not applicable (monitoring for underlying disease progression).

Action Threshold: Monitor for changes in renal function, especially in CKD patients.

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Symptom Monitoring

  • Symptoms of blood clots (e.g., chest pain, shortness of breath, pain/swelling in leg, sudden numbness/weakness)
  • Symptoms of severe allergic reaction (e.g., rash, hives, swelling of face/lips/tongue, difficulty breathing)
  • Symptoms of worsening hypertension (e.g., severe headache, blurred vision, confusion, seizures)
  • Symptoms of pure red cell aplasia (PRCA) (e.g., sudden worsening anemia, fatigue, pallor)
  • Symptoms of tumor progression (in cancer patients)

Special Patient Groups

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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 observed in animal studies.
Second Trimester: Potential for adverse developmental effects observed in animal studies.
Third Trimester: Potential for adverse developmental effects observed in animal studies.
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Lactation

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 Aranesp and any potential adverse effects on the breastfed infant from Aranesp or from the underlying maternal condition. Generally considered low risk due to large molecular weight.

Infant Risk: Low (due to large molecular weight, unlikely to pass into milk in significant amounts or be orally absorbed by infant).
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Pediatric Use

Dosing established for CKD-related anemia in pediatric patients (1 month to <18 years). Safety and efficacy in pediatric patients with chemotherapy-induced anemia have not been established.

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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 selection should be cautious, generally starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. Monitor closely for adverse events, particularly cardiovascular events.

Clinical Information

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Clinical Pearls

  • Always ensure adequate iron stores (TSAT >20%, ferritin >100 ng/mL) before and during darbepoetin alfa therapy to optimize response and avoid ESA resistance.
  • Closely monitor hemoglobin levels and adjust dose to avoid exceeding the target range (especially 11 g/dL in CKD patients) due to increased risks of cardiovascular events and mortality.
  • Blood pressure must be well-controlled before initiating and throughout darbepoetin alfa therapy, as it can cause or worsen hypertension.
  • Patients should be educated on the signs and symptoms of thrombotic events and instructed to seek immediate medical attention if they occur.
  • Darbepoetin alfa vials/syringes should not be shaken, as this can denature the protein and reduce its effectiveness.
  • For patients with cancer, darbepoetin alfa is only indicated for chemotherapy-induced anemia and should be discontinued once chemotherapy is completed.
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Alternative Therapies

  • Epoetin alfa (Epogen, Procrit, Retacrit)
  • Methoxy polyethylene glycol-epoetin beta (Mircera)
  • Iron supplementation (oral or IV)
  • Blood transfusions
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Cost & Coverage

Average Cost: Highly variable, typically several hundred to thousands of dollars per dose depending on strength and frequency. per vial/syringe
Insurance Coverage: Specialty Tier (requires prior authorization, often subject to strict criteria).
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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 is a valuable resource that provides important information about your treatment. 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 your medication, don't hesitate to discuss them with your doctor, pharmacist, or other healthcare provider.

In the event of a suspected overdose, it's crucial to seek immediate medical attention or contact your local poison control center. When reporting the incident, be prepared to provide detailed information, including the name of the medication taken, the amount, and the time it occurred.