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Aranesp 100mcg/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 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.
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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; 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 for guidance on what to do next.
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Lifestyle & Tips

  • Maintain adequate iron intake as advised by your doctor, as iron is crucial for red blood cell production.
  • Monitor your blood pressure regularly at home, as this medication can increase blood pressure.
  • Report any unusual symptoms immediately to your healthcare provider.
  • Do not stop taking this medication without consulting your doctor.
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Available Forms & Alternatives

Available Strengths:

Dosing & Administration

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Adult Dosing

Standard Dose: Varies significantly by indication and route of administration (IV or SC).

Condition-Specific Dosing:

Anemia of Chronic Kidney Disease (CKD) - Not on Dialysis: Initial: 0.45 mcg/kg IV or SC once every 4 weeks, or 0.75 mcg/kg IV or SC once every 2 weeks. Adjust dose to maintain hemoglobin (Hb) between 10-11 g/dL.
Anemia of Chronic Kidney Disease (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 Hb between 10-11 g/dL.
Anemia in Cancer Patients on Myelosuppressive Chemotherapy: Initial: 2.25 mcg/kg SC once weekly, or 500 mcg SC once every 3 weeks. Discontinue if no response after 8 weeks of therapy. Do not exceed 12 g/dL Hb.
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Pediatric Dosing

Neonatal: Not established
Infant: Not established
Child: Anemia of CKD (1 month to <18 years): Initial 0.45 mcg/kg IV or SC once weekly. Adjust dose to maintain Hb between 10-12 g/dL.
Adolescent: Anemia of CKD: Initial 0.45 mcg/kg IV or SC once weekly. Adjust dose to maintain Hb between 10-12 g/dL.
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Dose Adjustments

Renal Impairment:

Mild: No specific dose adjustment required, but monitor hemoglobin and adjust dose as per target.
Moderate: No specific dose adjustment required, but monitor hemoglobin and adjust dose as per target.
Severe: No specific dose adjustment required, but monitor hemoglobin and adjust dose as per target.
Dialysis: Darbepoetin alfa is indicated for anemia in CKD patients on dialysis. Dosing is adjusted based on hemoglobin levels.

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, stimulating their proliferation and differentiation into mature red blood cells. Darbepoetin alfa has a longer half-life than epoetin alfa due to its increased glycosylation, which results in more sialic acid residues.
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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 available
CnssPenetration: Limited

Elimination:

HalfLife: Approximately 21 hours (IV); approximately 49 hours (SC) in CKD patients.
Clearance: Approximately 0.0024 L/hr/kg (IV)
ExcretionRoute: Primarily renal (small amount of unchanged drug), but also hepatic degradation.
Unchanged: <10% (renal)
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Pharmacodynamics

OnsetOfAction: Increased reticulocytes within 7-10 days; increased hemoglobin within 2-6 weeks.
PeakEffect: Peak hemoglobin effect typically seen after several weeks of therapy.
DurationOfAction: Effects persist for several weeks after discontinuation due to long half-life.

Safety & Warnings

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BLACK BOX WARNING

ESAs increase the risk of death, myocardial infarction, stroke, venous thromboembolism, thrombosis of vascular access, and tumor progression or recurrence. To decrease these risks, use the lowest dose of ESA sufficient to reduce the need for red blood cell transfusions. In patients with chronic kidney disease (CKD), ESAs increase the risk of death, serious cardiovascular events, and stroke. In patients with cancer, ESAs shorten overall survival and/or increase the risk of tumor progression or recurrence in clinical studies.
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Side Effects

Urgent Side Effects: Seek Medical Help Immediately

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 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
Difficulty 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 notice:

 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 may cause side effects. While many people do not experience any side effects or only have minor ones, it is 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.
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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
  • Problems with vision or speech
  • Swelling, pain, or redness in an arm or leg (signs of a blood clot)
  • Uncontrolled high blood pressure (e.g., severe headache, blurred vision)
  • Signs of an allergic reaction (e.g., rash, itching, hives, swelling of face/lips/tongue/throat, difficulty breathing)
  • Unusual tiredness or paleness (may indicate pure red cell aplasia)
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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 an allergy to darbepoetin alfa or any component of this drug. Be sure to discuss the specifics of your allergy, including any symptoms you have 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, it is crucial to consult with your doctor.

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

All prescription and over-the-counter medications you are currently taking
 Any natural products or vitamins you are using
* Any existing health problems

Your doctor will assess this information to ensure it is safe for you to take this medication in conjunction with your other drugs and health conditions. Do not initiate, discontinue, or modify the dose of any medication without first consulting your doctor.
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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. Before undergoing 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.

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 with your doctor.

If you are pregnant, planning to become pregnant, or 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)
  • Increased blood viscosity
  • Increased risk of 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. Management typically involves phlebotomy to reduce hemoglobin and hematocrit levels, and supportive care for any complications.

Drug Interactions

Monitoring

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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: Adequate iron stores are essential for optimal response to ESAs. Iron supplementation may be required.

Timing: Before and during therapy

Blood pressure

Rationale: ESAs can cause or exacerbate hypertension.

Timing: Before initiation and regularly during therapy

Complete Blood Count (CBC) with differential

Rationale: To rule out other causes of anemia and assess overall hematologic status.

Timing: Before initiation

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Routine Monitoring

Hemoglobin (Hb)

Frequency: Weekly or bi-weekly initially, then every 2-4 weeks once stable.

Target: CKD: 10-11 g/dL; Cancer: Do not exceed 12 g/dL.

Action Threshold: Adjust dose if Hb rises rapidly (>1 g/dL in 2 weeks) or exceeds target range. Consider dose reduction or interruption if Hb approaches or exceeds 11 g/dL (CKD) or 12 g/dL (cancer).

Iron status (serum ferritin, TSAT)

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

Target: Ferritin >100 ng/mL (CKD non-dialysis), >200 ng/mL (CKD dialysis); TSAT >20%.

Action Threshold: Supplement iron if levels are below target.

Blood pressure

Frequency: Regularly (e.g., weekly or bi-weekly initially, then monthly).

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

Action Threshold: Manage hypertension aggressively; dose reduction or discontinuation of darbepoetin alfa may be necessary if hypertension is difficult to control.

Renal function (BUN, creatinine, GFR)

Frequency: Periodically, as clinically indicated.

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

Action Threshold: Not applicable (monitoring for underlying CKD progression).

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Symptom Monitoring

  • Signs of thrombosis (e.g., chest pain, shortness of breath, sudden numbness/weakness, swelling/pain in limb)
  • Signs of uncontrolled hypertension (e.g., severe headache, blurred vision, confusion)
  • Signs 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)
  • 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 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.
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Lactation

It is not known whether darbepoetin alfa is excreted in human milk. Caution should be exercised when 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 child from Aranesp or from the underlying maternal condition.

Infant Risk: L3 (Moderate risk - no human data, but molecular weight suggests limited transfer; potential for adverse effects on infant erythropoiesis is theoretical).
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Pediatric Use

Approved for anemia of CKD in pediatric patients (1 month to <18 years). Dosing is weight-based. Safety and efficacy in pediatric cancer patients receiving chemotherapy 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 for an elderly patient should be cautious, usually starting at the low end of the dosing range.

Clinical Information

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Clinical Pearls

  • Always ensure adequate iron stores before and during darbepoetin alfa therapy, as iron deficiency can lead to a poor response.
  • Monitor hemoglobin levels closely and adjust the dose to avoid exceeding target ranges, especially >11 g/dL in CKD patients and >12 g/dL in cancer patients, due to increased risks of adverse cardiovascular events and tumor progression.
  • Aggressively manage hypertension, as ESAs can cause or worsen high blood pressure.
  • Administer SC or IV; SC administration is generally preferred for convenience and has a longer absorption profile.
  • Do not shake the vial or syringe, as this can denature the glycoprotein.
  • Store refrigerated; protect from light. Do not freeze.
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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)
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Cost & Coverage

Average Cost: Varies widely by strength and quantity (e.g., $300 - $3000+) per vial/syringe
Insurance Coverage: Specialty Tier (often requires prior authorization and may have quantity limits)
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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 is a crucial patient fact sheet. Please read it carefully and review it again whenever you receive a refill. If you have any questions or concerns about this medication, consult 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. Be prepared to provide detailed information about the overdose, including the substance taken, the amount, and the time it occurred.