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Aranesp 150mcg/0.3ml Inj Alb Free

Manufacturer AMGEN Active Ingredient Darbepoetin Alfa Prefilled Syringes(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
Sep 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 chronic 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 carefully:

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 equipment. 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

  • Follow your doctor's instructions for diet, especially regarding iron intake.
  • Do not stop taking Aranesp without consulting your doctor.
  • Keep all appointments for blood tests and blood pressure checks.
  • Store the medication in the refrigerator, protect from light, and do not freeze. Do not shake the syringe.
  • Learn proper injection technique if administering at home.
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Available Forms & Alternatives

Available Strengths:

Dosing & Administration

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Adult Dosing

Standard Dose: Individualized based on hemoglobin levels and patient response. For CKD patients 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. 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. The 150mcg/0.3ml pre-filled syringe is a common maintenance dose, often administered once weekly or every two weeks, or less frequently depending on patient needs and target hemoglobin.
Dose Range: 0.45 - 0.75 mg

Condition-Specific Dosing:

CKD-related anemia (non-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 between 10-11 g/dL.
CKD-related anemia (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. Discontinue if no response after 8 weeks or if chemotherapy is completed.
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Pediatric Dosing

Neonatal: Not established
Infant: Not established
Child: For 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. Dosing frequency may be extended to every 2 weeks or monthly once stable.
Adolescent: For 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. Dosing frequency may be extended to every 2 weeks or monthly once stable.
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Dose Adjustments

Renal Impairment:

Mild: No specific dose adjustment based on GFR; dosing is guided by hemoglobin response and target levels.
Moderate: No specific dose adjustment based on GFR; dosing is guided by hemoglobin response and target levels.
Severe: No specific dose adjustment based on GFR; dosing is guided by hemoglobin response and target levels. Darbepoetin alfa is indicated for anemia associated with CKD, including severe renal impairment and dialysis.
Dialysis: Dosing is guided by hemoglobin response and target levels. Patients on dialysis typically require higher or more frequent doses than non-dialysis patients.

Hepatic Impairment:

Mild: No specific dose adjustment recommended.
Moderate: No specific dose adjustment recommended.
Severe: No specific dose adjustment recommended. Darbepoetin alfa is primarily catabolized, not extensively metabolized by the liver.

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 additional N-linked carbohydrate chains, allowing for less frequent dosing.
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Pharmacokinetics

Absorption:

Bioavailability: Approximately 37% (subcutaneous in CKD patients)
Tmax: Subcutaneous: 48-72 hours
FoodEffect: Not applicable (parenteral administration)

Distribution:

Vd: Approximately 0.06 L/kg (IV)
ProteinBinding: Not extensively protein bound
CnssPenetration: Limited

Elimination:

HalfLife: Intravenous: Approximately 21 hours (CKD patients); Subcutaneous: Approximately 46 hours (CKD patients)
Clearance: Approximately 0.02 mL/min/kg (IV)
ExcretionRoute: Primarily catabolism; minimal renal excretion of intact drug.
Unchanged: <10% (renal excretion)
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Pharmacodynamics

OnsetOfAction: Increase in reticulocytes typically seen within 7-10 days; significant increase in hemoglobin usually within 2-6 weeks.
PeakEffect: Peak hemoglobin response typically observed after several weeks of consistent dosing.
DurationOfAction: Due to its long half-life, effects on erythropoiesis persist for several days to weeks after a single dose, allowing for less frequent administration (weekly, bi-weekly, or monthly).

Safety & Warnings

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BLACK BOX WARNING

Increased risk of death, serious cardiovascular events, and stroke when 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.
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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 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 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: Get 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 serious health problems and even death. Seek immediate medical attention 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 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.
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Seek Immediate Medical Attention If You Experience:

  • Sudden severe headache, confusion, vision changes (signs of high blood pressure or stroke)
  • Chest pain, shortness of breath, pain or swelling in your leg (signs of blood clot)
  • Unusual tiredness, dizziness, pale skin (signs of worsening anemia or pure red cell aplasia)
  • Rash, hives, itching, swelling of face/lips/tongue, difficulty breathing (signs of allergic reaction)
  • Signs of tumor growth or recurrence (in cancer patients, report any new or worsening symptoms)
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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:

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 (OTC) 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 and to identify potential interactions between this medication and other substances you are taking.

Do not start, stop, or change the dosage of any medication without first consulting your doctor to confirm that it is safe to do so.
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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 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. 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 to discuss the potential benefits and risks to you and your baby. This will enable you to make an informed decision about your treatment.
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Overdose Information

Overdose Symptoms:

  • Polycythemia (excessively high red blood cell count), which can lead to increased blood viscosity and risk of thrombotic events (e.g., stroke, heart attack, deep vein thrombosis).

What to Do:

In case of overdose, contact a poison control center (1-800-222-1222) or seek emergency medical attention immediately. Management typically involves phlebotomy to reduce hemoglobin levels if polycythemia is severe, and supportive care for any complications.

Drug Interactions

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

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.

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Routine Monitoring

Hemoglobin (Hb)

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

Target: 10-11 g/dL (CKD patients); avoid exceeding 11 g/dL.

Action Threshold: If Hb increases by >1 g/dL in a 2-week period or approaches 11 g/dL, consider dose reduction. If Hb falls below target or does not increase, consider dose increase or investigate other causes of anemia.

Iron status (TSAT, Ferritin)

Frequency: Monthly or quarterly, or as clinically indicated.

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

Action Threshold: If iron stores are low, initiate or increase iron supplementation.

Blood Pressure (BP)

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

Target: Individualized, typically <140/90 mmHg.

Action Threshold: If hypertension develops or worsens, initiate or intensify antihypertensive therapy.

Renal function (eGFR, creatinine)

Frequency: Periodically, as part of routine CKD management.

Target: Not applicable (monitoring for disease progression).

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

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Symptom Monitoring

  • Symptoms of uncontrolled hypertension (headache, blurred vision, dizziness)
  • Symptoms of thrombotic events (chest pain, shortness of breath, sudden weakness or numbness, swelling/pain in a limb)
  • Symptoms of allergic reactions (rash, itching, hives, swelling of face/lips/tongue, difficulty breathing)
  • Symptoms of pure red cell aplasia (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 have shown adverse effects on the fetus, 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 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: Low to moderate risk. Monitor breastfed infants for adverse effects.
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Pediatric Use

Approved for anemia associated with CKD in pediatric patients 1 month to 16 years of age. Dosing is weight-based and adjusted to maintain target hemoglobin levels. 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 for an elderly patient should be cautious, usually 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.

Clinical Information

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Clinical Pearls

  • Always individualize darbepoetin alfa dosing to achieve and maintain hemoglobin levels within the target range (10-11 g/dL for CKD patients) to minimize risks.
  • Ensure adequate iron stores (TSAT ≥20%, Ferritin ≥100 ng/mL) before and during ESA therapy, as iron deficiency is a common cause of ESA hyporesponsiveness.
  • Monitor blood pressure closely, as hypertension is a common side effect and may require aggressive management.
  • Educate patients on the Black Box Warning risks, especially regarding cardiovascular events and tumor progression, and the importance of not exceeding target hemoglobin levels.
  • Pure Red Cell Aplasia (PRCA) is a rare but serious adverse event associated with ESAs, characterized by a sudden decrease in hemoglobin and reticulocytes, often associated with anti-erythropoietin antibodies. Discontinue Aranesp if PRCA is suspected.
  • Do not shake the Aranesp syringe, as this can denature the protein and reduce its effectiveness.
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Alternative Therapies

  • Epoetin alfa (Procrit, Epogen, Retacrit)
  • Methoxy polyethylene glycol-epoetin beta (Mircera)
  • Roxadustat (Evrenzo) - oral HIF-PH inhibitor for CKD anemia
  • Iron supplementation (oral or intravenous)
  • Red blood cell transfusions (for acute, severe anemia or when ESAs are contraindicated/ineffective)
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Cost & Coverage

Average Cost: Highly variable, typically several hundred to over a thousand USD per dose depending on strength and frequency. per pre-filled syringe
Insurance Coverage: Specialty Tier (requires prior authorization, often subject to step therapy and 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 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. 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, we encourage you 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 seeking help, be prepared to provide details about the overdose, including the medication taken, the amount, and the time it occurred.