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Aranesp 40mcg/0.4ml 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
Hematopoietic agent; 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?

Aranesp is a man-made protein that is very similar to a natural substance in your body called erythropoietin. Erythropoietin helps your bone marrow make more red blood cells. Aranesp is used to treat anemia (low red blood cell count) in people with chronic kidney disease or in some cancer patients receiving chemotherapy.
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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 properly to ensure its effectiveness and safety.

Important Handling Instructions

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 disposal container. Do not reuse needles or other items.

Disposal and Storage

Store the medication in the refrigerator; do not freeze.
 When the sharps disposal container is full, follow local regulations for proper disposal.
* If you have any questions or concerns, consult your doctor or pharmacist.

Missed Dose

If you miss a dose, contact your doctor to determine the best course of action.
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Lifestyle & Tips

  • Maintain adequate iron intake as prescribed by your doctor, as iron is essential for Aranesp to work effectively.
  • Monitor your blood pressure regularly as instructed by your healthcare provider, as Aranesp can cause or worsen high blood pressure.
  • Do not shake the syringe, as this can damage the medication.
  • Store in the refrigerator, protect from light, and do not freeze.
  • Follow proper injection technique if self-administering, and rotate injection sites.
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Available Forms & Alternatives

Available Strengths:

Dosing & Administration

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Adult Dosing

Standard Dose: Varies by indication. For CKD anemia: 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:

Chronic Kidney Disease (CKD) Anemia (not on dialysis): Initial 0.45 mcg/kg IV or SC once weekly, or 0.75 mcg/kg IV or SC once every 2 weeks. Titrate to maintain hemoglobin (Hb) between 10-11 g/dL.
Chronic Kidney Disease (CKD) 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. 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 if no response after 8 weeks of therapy or 4 weeks after chemotherapy completion.
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Pediatric Dosing

Neonatal: Not established
Infant: Not established for all indications. For CKD anemia (≥1 month): 0.45 mcg/kg IV or SC once weekly, or 0.75 mcg/kg IV or SC once every 2 weeks.
Child: For CKD anemia (≥1 month): 0.45 mcg/kg IV or SC once weekly, or 0.75 mcg/kg IV or SC once every 2 weeks. Not recommended for chemotherapy-induced anemia in pediatric patients.
Adolescent: For CKD anemia (≥1 month): 0.45 mcg/kg IV or SC once weekly, or 0.75 mcg/kg IV or SC once every 2 weeks. Not recommended for chemotherapy-induced anemia in pediatric patients.
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Dose Adjustments

Renal Impairment:

Mild: No specific adjustment beyond standard CKD dosing, as CKD is a primary indication.
Moderate: No specific adjustment beyond standard CKD dosing, as CKD is a primary indication.
Severe: No specific adjustment beyond standard CKD dosing, as CKD is a primary indication.
Dialysis: Dosing for patients on dialysis is included in the standard CKD anemia dosing. Monitor Hb closely.

Hepatic Impairment:

Mild: No specific dose adjustment recommended.
Moderate: No specific dose adjustment recommended.
Severe: No specific dose adjustment recommended.

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 erythroid progenitor cells to stimulate red blood cell production and differentiation. 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: Subcutaneous (SC): Approximately 37% (CKD patients), 49% (cancer patients).
Tmax: Subcutaneous (SC): 48-72 hours.
FoodEffect: Not applicable for injectable formulation.

Distribution:

Vd: Approximately 0.06 L/kg (intravenous).
ProteinBinding: Not extensively studied, but generally low for protein therapeutics.
CnssPenetration: Limited

Elimination:

HalfLife: Intravenous (IV): Approximately 21 hours (CKD patients), 25 hours (cancer patients). Subcutaneous (SC): Approximately 49 hours (CKD patients), 74 hours (cancer patients).
Clearance: Not available (primarily catabolized).
ExcretionRoute: Primarily catabolism; a small amount is excreted renally.
Unchanged: Not available (primarily catabolized).
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Pharmacodynamics

OnsetOfAction: Hemoglobin levels typically begin to rise within 2-6 weeks of initiating therapy.
PeakEffect: Peak hemoglobin increase is observed over several weeks of continued therapy.
DurationOfAction: Due to its longer half-life, darbepoetin alfa can be administered less frequently (e.g., weekly or bi-weekly) compared to epoetin alfa.

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. Aranesp is not indicated for patients with cancer receiving myelosuppressive chemotherapy when the anticipated outcome is cure. Discontinue Aranesp when the chemotherapy course is completed.
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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, changes in color, or pain in a leg or arm
Trouble speaking or swallowing

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

This medication may cause a severe skin reaction, which can lead to serious health problems and even death. Seek medical help right away 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. Many people experience no side effects or only mild ones. 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

This is not an exhaustive list of possible 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:

  • Sudden chest pain, shortness of breath, or pain in your legs (signs of blood clots)
  • Sudden numbness or weakness on one side of your body, sudden severe headache, sudden vision changes, or trouble speaking (signs of stroke)
  • Unusual tiredness or dizziness, pale skin, or worsening shortness of breath (signs of worsening anemia or PRCA)
  • Severe headache, blurred vision, or seizures (signs of very high blood pressure)
  • Signs of an allergic reaction: rash, itching, swelling of the face/lips/tongue/throat, difficulty breathing
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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 to ensure safe treatment:

Any allergies you have, including allergies to this medication, its components, or other substances. Be sure to describe the allergic reaction and its symptoms.
 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 condition 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 may have. Your doctor and pharmacist need this information to assess potential interactions and ensure your safety.

Remember, do not start, stop, or change the dose of any medication without first consulting your doctor to confirm 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. 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 checking your blood pressure. Additionally, follow your doctor's guidance for undergoing blood tests, 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, planning to become pregnant, or breastfeeding, inform your doctor 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)
  • Hyperviscosity syndrome (blood becomes too thick, leading to symptoms like headache, dizziness, visual disturbances, and increased risk of thrombotic events)

What to Do:

Management typically involves phlebotomy (removal of blood) to reduce hemoglobin and hematocrit levels. Call 1-800-222-1222 (Poison Control) or seek immediate medical attention.

Drug Interactions

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Moderate Interactions

  • Iron supplements (essential for optimal response, not an interaction in the negative sense but a co-requirement)
  • Other myelosuppressive agents (may affect erythropoietic response)

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 (serum ferritin, transferrin saturation [TSAT])

Rationale: To ensure adequate iron stores for optimal erythropoiesis; iron deficiency can limit response.

Timing: Prior to initiation of therapy.

Blood pressure

Rationale: To establish baseline and identify pre-existing hypertension, which can be exacerbated.

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 (do not exceed 11 g/dL).

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

Iron status (serum ferritin, TSAT)

Frequency: Monthly or quarterly, or as clinically indicated.

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

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

Blood pressure

Frequency: Regularly (e.g., weekly or bi-weekly initially, then as clinically indicated).

Target: Individualized, within normal limits.

Action Threshold: If blood pressure increases or hypertension develops/worsens, initiate or intensify antihypertensive therapy.

Complete Blood Count (CBC) with differential

Frequency: Periodically.

Target: Not applicable for specific target, but to monitor for other cytopenias.

Action Threshold: Evaluate for other causes of anemia if response is inadequate.

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Symptom Monitoring

  • Signs and symptoms of cardiovascular events (e.g., chest pain, shortness of breath, sudden numbness or weakness, vision changes, slurred speech)
  • Signs and symptoms of allergic reactions (e.g., rash, urticaria, angioedema, anaphylaxis)
  • Signs and symptoms of pure red cell aplasia (PRCA) (e.g., sudden worsening of anemia, transfusion dependence)
  • Signs and symptoms of tumor progression or recurrence (in cancer patients)
  • Headache, seizures (especially with rapid Hb rise or uncontrolled hypertension)

Special Patient Groups

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Pregnancy

Category C. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. Animal studies have shown adverse effects on fetal development.

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. 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 - unknown excretion, potential for adverse effects).
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Pediatric Use

Approved for the treatment of anemia associated with chronic kidney disease in pediatric patients 1 month of age and older. Safety and efficacy for chemotherapy-induced anemia have not been established in pediatric patients.

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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 adjustment is generally not required based on age alone, but monitor closely for adverse events, particularly cardiovascular events.

Clinical Information

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Clinical Pearls

  • Aranesp has a longer half-life than epoetin alfa, allowing for less frequent dosing (e.g., weekly or bi-weekly).
  • Always ensure adequate iron stores (ferritin >100 ng/mL, TSAT >20%) before and during Aranesp therapy, as iron deficiency is the most common cause of resistance to ESAs.
  • The goal of ESA therapy is to reduce the need for red blood cell transfusions, not to achieve normal hemoglobin levels. Do not target a hemoglobin level above 11 g/dL due to increased risks.
  • Closely monitor blood pressure, as hypertension is a common side effect and can be severe.
  • Educate patients on the signs and symptoms of serious cardiovascular events (e.g., stroke, MI, VTE) and the importance of seeking immediate medical attention if they occur.
  • In cancer patients, Aranesp should be discontinued once the chemotherapy course is completed, and it is not indicated for patients with cancer receiving myelosuppressive chemotherapy when the anticipated outcome is cure.
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Alternative Therapies

  • Epoetin alfa (e.g., Epogen, Procrit, Retacrit) - another ESA with a shorter half-life.
  • Blood transfusions (for acute, severe anemia or when ESA therapy is contraindicated/ineffective).
  • Iron supplementation (oral or intravenous) - often used in conjunction with ESAs or as primary treatment for iron deficiency anemia.
  • Other agents for anemia depending on underlying cause (e.g., vitamin B12, folic acid for deficiency anemias).
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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 prefilled syringe
Insurance Coverage: Tier 3 or Specialty Tier (requires prior authorization and often step therapy)
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General Drug Facts

If your symptoms or health issues persist or worsen, it's 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 provides crucial information. Please read this guide carefully and review it again whenever you receive a refill. If you have any questions or concerns about this medication, don't hesitate to 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.