Home › Medicine

Aranesp 200mcg/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.
🏷️
Drug Class
Erythropoiesis-Stimulating Agent (ESA)
🧬
Pharmacologic Class
Recombinant Human Erythropoietin Analog
🤰
Pregnancy Category
Category C
✅
FDA Approved
Sep 2001
⚖️
DEA Schedule
Not Controlled

Overview

ℹ️

What is this medicine?

Aranesp is a medicine that helps your body make more red blood cells. It is used to treat anemia (low red blood cell count) in people with kidney disease or in some cancer patients receiving chemotherapy. It works like a natural substance in your body called erythropoietin.
📋

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 vial, 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 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.
💡

Lifestyle & Tips

  • Maintain adequate iron intake as prescribed by your doctor (often requires iron supplements).
  • Follow a healthy diet as recommended by your healthcare provider.
  • Monitor your blood pressure regularly at home as instructed.
  • Do not stop taking Aranesp without consulting your doctor.
  • Keep all appointments for blood tests and doctor visits.
💊

Available Forms & Alternatives

Available Strengths:

Dosing & Administration

👨‍⚕️

Adult Dosing

Standard Dose: Chronic Kidney Disease (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. Chronic Kidney Disease (CKD) Patients Not on Dialysis: Initial 0.45 mcg/kg IV or SC once every 4 weeks. Chemotherapy-Induced Anemia: Initial 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 (on dialysis): Target hemoglobin 10-11 g/dL. Adjust dose to maintain hemoglobin within target range. Do not exceed 11 g/dL.
CKD (not on dialysis): Target hemoglobin 10-11 g/dL. Adjust dose to maintain hemoglobin within target range. Do not exceed 11 g/dL.
Chemotherapy-Induced Anemia: Target hemoglobin >10 g/dL. Discontinue if chemotherapy is completed or if hemoglobin exceeds 10 g/dL (for patients with cancer not receiving myelosuppressive chemotherapy) or 11 g/dL (for patients with cancer receiving myelosuppressive chemotherapy).
👶

Pediatric Dosing

Neonatal: Not established
Infant: Not established
Child: CKD Patients (1 month to <18 years) on Dialysis: Initial 0.45 mcg/kg IV or SC once weekly, or 0.75 mcg/kg IV or SC once every 2 weeks. CKD Patients (1 month to <18 years) Not on Dialysis: Initial 0.45 mcg/kg IV or SC once every 4 weeks.
Adolescent: CKD Patients (1 month to <18 years) on Dialysis: Initial 0.45 mcg/kg IV or SC once weekly, or 0.75 mcg/kg IV or SC once every 2 weeks. CKD Patients (1 month to <18 years) Not on Dialysis: Initial 0.45 mcg/kg IV or SC once every 4 weeks.
⚕️

Dose Adjustments

Renal Impairment:

Mild: No specific dose adjustment based on GFR; dosing is based on hemoglobin response and target.
Moderate: No specific dose adjustment based on GFR; dosing is based on hemoglobin response and target.
Severe: No specific dose adjustment based on GFR; dosing is based on hemoglobin response and target.
Dialysis: Dosing specifically for patients on dialysis is provided above. Hemoglobin levels should be monitored closely.

Hepatic Impairment:

Mild: No specific dose adjustment recommended.
Moderate: No specific dose adjustment recommended.
Severe: Use with caution; limited data available.

Pharmacology

🔬

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 its increased glycosylation, which results in more sialic acid residues.
📊

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 administration)
ProteinBinding: Not extensively protein bound
CnssPenetration: Limited

Elimination:

HalfLife: Approximately 49 hours (SC administration); Approximately 21 hours (IV administration)
Clearance: Approximately 0.025 L/hr/kg (IV administration)
ExcretionRoute: Primarily catabolism; minimal renal excretion of intact drug.
Unchanged: Less than 10% (renal excretion of intact drug)
⏱️

Pharmacodynamics

OnsetOfAction: Increase in reticulocyte count typically observed within 7-10 days.
PeakEffect: Peak hemoglobin response typically observed within 2-6 weeks.
DurationOfAction: Due to its long half-life, effects persist for several weeks after discontinuation.

Safety & Warnings

⚠️

BLACK BOX WARNING

ESAs increase the risk of death, myocardial infarction, stroke, venous thromboembolism, and thrombosis of vascular access in patients with chronic kidney disease. In controlled clinical trials of patients with cancer, ESAs shortened overall survival and/or increased the risk of tumor progression or recurrence. To decrease these risks, use the lowest dose of Aranesp sufficient to avoid red blood cell transfusions. For patients with chronic kidney disease, do not exceed a hemoglobin level of 11 g/dL. For patients with cancer, use Aranesp only for anemia due to myelosuppressive chemotherapy, and discontinue Aranesp when chemotherapy is completed. Aranesp is not indicated for patients with cancer receiving myelosuppressive chemotherapy when the anticipated outcome is cure.
⚠️

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 Reactions: Seek Medical Help Right Away

In rare cases, this medication may cause a severe skin reaction (Stevens-Johnson syndrome/toxic epidermal necrolysis), which can lead to serious health problems and even death. If you notice any of the following symptoms, seek medical attention immediately:

 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 experience no side effects or only minor ones, it's essential to discuss any concerns with your doctor. If you experience any of the following side effects or any other symptoms that bother you or do not go away, contact your doctor:

Stomach pain
 Cough

This is not an exhaustive list of possible side effects. If you have questions or concerns about side effects, consult your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
🚨

Seek Immediate Medical Attention If You Experience:

  • Sudden chest pain or shortness of breath (signs of blood clot)
  • Pain, swelling, warmth, or redness in an arm or leg (signs of blood clot)
  • Sudden numbness or weakness, especially on one side of the body (signs of stroke)
  • Sudden severe headache, confusion, or problems with vision, speech, or balance (signs of stroke or severe high blood pressure)
  • Unusual tiredness or weakness, dizziness, or fainting (signs of very high hemoglobin or other issues)
  • Signs of an allergic reaction (rash, itching, hives, swelling of face/lips/tongue/throat, difficulty breathing)
  • Worsening anemia or lack of response to treatment (may indicate pure red cell aplasia)
📋

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 symptoms you experienced.
 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 ensure safe treatment. Never start, stop, or adjust the dosage of any medication without first consulting your doctor to confirm it is safe to do so.
⚠️

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 have surgery, discuss this with your doctor, as you may need to take an additional medication to prevent blood clots while using this drug.

Regular monitoring of your blood pressure is crucial, as this medication can cause high blood pressure. Follow your doctor's instructions for checking your blood pressure. Additionally, have your blood work checked as directed by your doctor and discuss the results with them.

If you have a latex allergy, be sure to inform your doctor. It is also important to adhere to the prescribed dosage and not exceed it, as taking more than the recommended amount can increase the risk of severe side effects. If you accidentally take more of this medication than prescribed, contact your doctor immediately.

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

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

Overdose Information

Overdose Symptoms:

  • Polycythemia (excessively high red blood cell count)
  • Symptoms related to increased blood viscosity (e.g., headache, dizziness, hypertension, thrombotic events)

What to Do:

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

Drug Interactions

🟡

Moderate Interactions

  • Iron supplements (if iron deficient, response to darbepoetin alfa may be blunted)
  • Other erythropoiesis-stimulating agents (concurrent use not recommended)

Monitoring

🔬

Baseline Monitoring

Hemoglobin (Hb)

Rationale: To establish baseline and guide initial dosing.

Timing: Prior to initiation of therapy.

Iron status (TSAT, Ferritin)

Rationale: To ensure adequate iron stores for optimal response to ESA therapy. Iron deficiency will limit response.

Timing: Prior to initiation of therapy.

Blood Pressure

Rationale: To establish baseline and identify pre-existing hypertension, which may worsen with ESA therapy.

Timing: Prior to initiation of therapy.

📊

Routine Monitoring

Hemoglobin (Hb)

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

Target: 10-11 g/dL (CKD); >10 g/dL (Chemotherapy-induced anemia)

Action Threshold: If Hb increases by >1 g/dL in any 2-week period or exceeds target range, consider dose reduction or interruption. If Hb does not increase by 1 g/dL after 4 weeks of therapy, consider dose increase.

Iron status (TSAT, Ferritin)

Frequency: Monthly or quarterly, or as clinically indicated.

Target: TSAT >20%, Ferritin >100 ng/mL (CKD); TSAT >20%, Ferritin >100 ng/mL (Chemotherapy-induced anemia)

Action Threshold: If iron stores are inadequate, administer supplemental iron.

Blood Pressure

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

Target: Individualized, within normal limits for patient.

Action Threshold: If significant increase in blood pressure or new onset hypertension, manage appropriately with antihypertensive therapy or dose reduction/interruption of darbepoetin alfa.

👁️

Symptom Monitoring

  • Symptoms of anemia (fatigue, shortness of breath, pallor)
  • Symptoms of hypertension (headache, dizziness, blurred vision)
  • Symptoms of thrombotic events (chest pain, shortness of breath, pain/swelling in leg, sudden weakness/numbness)
  • Symptoms of allergic reactions (rash, itching, hives, swelling, difficulty breathing)
  • Symptoms of pure red cell aplasia (sudden worsening anemia, lack of response to therapy)

Special Patient Groups

🤰

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.
🤱

Lactation

It is not known 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 child from Aranesp or from the underlying maternal condition.

Infant Risk: Low risk based on molecular weight and typical administration route, but data are limited. Monitor infant for adverse effects.
👶

Pediatric Use

Approved for use in pediatric patients (1 month to <18 years) with CKD-associated anemia. Dosing is weight-based. Safety and efficacy in pediatric patients with chemotherapy-induced anemia have not been established.

👴

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 not typically required based on age alone, but monitor for comorbidities and potential increased risk of cardiovascular events.

Clinical Information

💎

Clinical Pearls

  • Always ensure adequate iron stores (TSAT >20%, Ferritin >100 ng/mL) before and during darbepoetin alfa therapy, as iron deficiency is the most common cause of ESA hyporesponsiveness.
  • Monitor hemoglobin levels closely and adjust dose to avoid exceeding target ranges, especially 11 g/dL in CKD patients, due to increased cardiovascular and thrombotic risks.
  • Blood pressure should be well-controlled before initiating therapy and monitored frequently during treatment, as hypertension is a common side effect.
  • Patients should be educated on the signs and symptoms of serious adverse events, including blood clots and severe hypertension, and instructed to seek immediate medical attention if they occur.
  • Darbepoetin alfa has a longer half-life than epoetin alfa, allowing for less frequent dosing (e.g., once weekly, bi-weekly, or monthly).
🔄

Alternative Therapies

  • Epoetin alfa (Epogen, Procrit)
  • Methoxy polyethylene glycol-epoetin beta (Mircera)
  • Iron supplementation (oral or IV)
  • Red blood cell transfusions (for acute, severe anemia)
💰

Cost & Coverage

Insurance Coverage: Specialty Tier (often requires prior authorization and may have quantity limits)
📚

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.