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Aranesp 25mcg/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
C
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FDA Approved
Oct 2001
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DEA Schedule
Not Controlled

Overview

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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) caused by kidney disease or certain types of cancer 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 use it if it appears cloudy, is leaking, contains particles, or 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, and follow local regulations for disposing of the full box.

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. If you have any questions or concerns about using this medication, consult with your doctor or pharmacist.
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Lifestyle & Tips

  • Maintain a healthy diet, especially ensuring adequate iron intake (as advised by your doctor).
  • Monitor blood pressure regularly at home as instructed by your healthcare provider.
  • Report any unusual symptoms immediately to your doctor.
  • Do not stop taking Aranesp 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 (IV/SC). For CKD patients not on dialysis: 0.45 mcg/kg IV or SC once every 4 weeks. For CKD patients on dialysis: 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: 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: 0.45 mcg/kg IV or SC once every 4 weeks. Initial dose for patients currently on epoetin alfa: convert to darbepoetin alfa once weekly or once every 2 weeks.
CKD_on_dialysis: 0.45 mcg/kg IV or SC once weekly or 0.75 mcg/kg IV or SC once every 2 weeks. Initial dose for patients currently on epoetin alfa: convert to darbepoetin alfa once weekly or once every 2 weeks.
Chemotherapy_induced_anemia: 2.25 mcg/kg SC once weekly or 500 mcg SC once every 3 weeks. Discontinue when chemotherapy is completed.
Perioperative_blood_transfusion_reduction: 6.75 mcg/kg SC as a single dose 3 weeks prior to surgery, or 3.375 mcg/kg SC once weekly for 2 doses (10 and 3 days prior to surgery).
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Pediatric Dosing

Neonatal: Not established
Infant: Not established
Child: CKD patients (1 month to 17 years): Initial dose 0.45 mcg/kg IV or SC once weekly. Titrate to maintain Hb between 10-12 g/dL.
Adolescent: CKD patients (1 month to 17 years): Initial dose 0.45 mcg/kg IV or SC once weekly. Titrate to maintain Hb between 10-12 g/dL.
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Dose Adjustments

Renal Impairment:

Mild: No specific dose adjustment required, but close monitoring of hemoglobin is essential.
Moderate: No specific dose adjustment required, but close monitoring of hemoglobin is essential.
Severe: No specific dose adjustment required, but close monitoring of hemoglobin is essential. Dosage is based on body weight and hemoglobin response.
Dialysis: Dosing is adjusted based on whether the patient is on dialysis or not, as specified in adult dosing. IV route is preferred for patients on hemodialysis.

Hepatic Impairment:

Mild: No specific dose adjustment provided in labeling.
Moderate: No specific dose adjustment provided in labeling.
Severe: No specific dose adjustment provided in labeling.

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 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 its increased glycosylation, which results in a longer circulating half-life and allows for less frequent dosing.
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Pharmacokinetics

Absorption:

Bioavailability: Approximately 37% (SC administration)
Tmax: Approximately 48 hours (SC administration)
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 in CKD patients); Approximately 49 hours (SC in CKD patients); Approximately 70 hours (SC in cancer patients)
Clearance: Approximately 0.03 L/hr/kg (IV in CKD patients)
ExcretionRoute: Renal and hepatic clearance
Unchanged: Minimal
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Pharmacodynamics

OnsetOfAction: Increase in reticulocyte count typically observed within 7-10 days; increase in hemoglobin within 2-6 weeks.
PeakEffect: Peak hemoglobin response typically observed within 2-6 weeks of initiation or dose adjustment.
DurationOfAction: Due to its long half-life, effects persist for several days to weeks after the last dose, allowing for weekly or bi-weekly dosing.

Safety & Warnings

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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 reduce the need for red blood cell transfusions. For patients with chronic kidney disease (CKD), ESAs increase the risk of death, serious cardiovascular events, and stroke when administered to target hemoglobin levels of greater than 11 g/dL. For patients with cancer, ESAs shorten overall survival and/or increase the risk of tumor progression or recurrence in patients with breast, non-small cell lung, head and neck, lymphoid, and cervical cancers. The risks of Aranesp therapy may outweigh the benefits in patients with cancer who are not receiving myelosuppressive chemotherapy when the anticipated outcome is cure.
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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 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 Reaction: Seek Medical Help Right Away

A severe skin reaction, known as Stevens-Johnson syndrome or toxic epidermal necrolysis, may occur. This condition can cause severe health problems and may be life-threatening. 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

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 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)
  • Uncontrolled high blood pressure (e.g., severe headache, blurred vision)
  • Signs of an allergic reaction (e.g., rash, hives, itching, swelling of face/lips/tongue, difficulty breathing)
  • Unusual tiredness, dizziness, or pale skin (signs of worsening anemia or PRCA)
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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 medications you are currently taking
 Any natural products or vitamins you are using
* Existing health problems or medical conditions

Your doctor will assess the safety of taking this medication with your other drugs and health conditions. Do not initiate, stop, or modify the dose of any medication without first consulting your doctor to ensure your safety.
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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, 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 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), which can lead to increased blood viscosity and thrombotic events (e.g., stroke, heart attack, blood clots).

What to Do:

Management involves phlebotomy to reduce hemoglobin levels and supportive care. Call 1-800-222-1222 (Poison Control) or seek immediate medical attention.

Drug Interactions

Monitoring

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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: Adequate iron stores are essential for optimal response to ESAs. Iron deficiency can lead to resistance.

Timing: Prior to and during therapy.

Blood Pressure (BP)

Rationale: Hypertension is a common adverse effect and can be exacerbated by ESA therapy.

Timing: Prior to initiation and regularly during therapy.

Complete Blood Count (CBC) with differential

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

Timing: Prior to initiation.

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Routine Monitoring

Hemoglobin (Hb)

Frequency: Weekly or bi-weekly until stable, then monthly.

Target: 10-11 g/dL (CKD patients); lowest Hb level necessary to avoid red blood cell transfusions (cancer patients). Avoid exceeding 11 g/dL.

Action Threshold: If Hb increases by >1 g/dL in any 2-week period or approaches 11 g/dL, consider dose reduction. If Hb exceeds 11 g/dL, hold dose or reduce significantly.

Iron status (serum ferritin, TSAT)

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

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

Action Threshold: If iron deficiency is present, administer supplemental iron.

Blood Pressure (BP)

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

Target: Individualized, typically <140/90 mmHg.

Action Threshold: If BP increases significantly or becomes difficult to control, consider dose reduction or discontinuation of darbepoetin alfa and/or initiation/adjustment of antihypertensive therapy.

Renal function (BUN, creatinine, GFR)

Frequency: Periodically, especially in CKD patients.

Target: Not applicable (monitoring for disease progression).

Action Threshold: Not applicable (monitoring for disease progression).

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Symptom Monitoring

  • Signs of thrombosis (e.g., chest pain, shortness of breath, sudden numbness or weakness, vision changes, swelling/pain in leg)
  • Signs of severe allergic reaction (e.g., rash, hives, itching, swelling of face/lips/tongue, difficulty breathing)
  • Symptoms of uncontrolled hypertension (e.g., severe headache, blurred vision, dizziness)
  • Symptoms of pure red cell aplasia (PRCA) (e.g., sudden worsening of anemia, fatigue, pallor)
  • Symptoms of tumor progression or recurrence (in cancer patients)

Special Patient Groups

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Pregnancy

Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. Animal studies show adverse effects, but human data are limited. Consider the risk of increased maternal blood pressure.

Trimester-Specific Risks:

First Trimester: Limited human data. Animal studies suggest potential for adverse developmental effects at high doses.
Second Trimester: Limited human data. Risk of hypertension in the mother may increase.
Third Trimester: Limited human data. Risk of hypertension in the mother may increase. Consider potential for increased risk of thrombosis.
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Lactation

It is not known 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. The molecular weight is high, suggesting limited transfer into milk, but caution is advised.

Infant Risk: L3 - Moderate concern. Potential for adverse effects on the infant is possible, but controlled studies are lacking. Monitor infant for adverse effects.
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Pediatric Use

Approved for anemia associated with CKD in pediatric patients 1 month and older. Dosing is weight-based. Safety and efficacy for chemotherapy-induced anemia in pediatric patients 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.

Clinical Information

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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.
  • Strictly adhere to the hemoglobin target of 10-11 g/dL for CKD patients and the lowest effective dose for cancer patients to minimize serious risks (thrombosis, cardiovascular events, tumor progression).
  • Monitor blood pressure closely, especially at the start of therapy and with dose increases, as hypertension is a common side effect.
  • Educate patients on the signs and symptoms of blood clots and uncontrolled hypertension, and instruct them to seek immediate medical attention if these occur.
  • For patients on hemodialysis, the IV route is generally preferred for convenience and to ensure full dose delivery.
  • Pure Red Cell Aplasia (PRCA) is a rare but serious adverse event associated with ESAs, characterized by sudden worsening anemia and absence of red cell precursors in bone marrow. If suspected, discontinue Aranesp and investigate for anti-erythropoietin antibodies.
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Alternative Therapies

  • Epoetin alfa (Epogen, Procrit, Retacrit)
  • Methoxy polyethylene glycol-epoetin beta (Mircera)
  • Iron supplementation (oral or IV)
  • Red blood cell transfusions (for acute, severe anemia or when ESA therapy is contraindicated/ineffective)
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Cost & Coverage

Average Cost: Varies widely by dosage and quantity (e.g., $100s to $1000s per vial/syringe) per vial/prefilled syringe
Insurance Coverage: Tier 3 or 4 (Specialty Drug) on most formularies, often requiring prior authorization and step therapy.
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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, do not share your medication with others or take someone else's medication. This medication is accompanied by a Medication Guide, which provides important 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 incident, be prepared to provide details about the medication taken, the amount, and the time it occurred.