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Aranesp 10mcg/0.4ml Singleject Syr

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
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) 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 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 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 to determine the best course of action.
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Lifestyle & Tips

  • Maintain a healthy diet, especially ensuring adequate iron intake (as advised by your doctor).
  • Monitor your blood pressure regularly as instructed by your healthcare provider.
  • Report any unusual symptoms or side effects promptly 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 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. For chemotherapy-induced anemia: Initial 2.25 mcg/kg SC once weekly or 500 mcg SC once every 3 weeks.

Condition-Specific Dosing:

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. Target Hb 10-11 g/dL.
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. Target Hb 10-11 g/dL.
Chemotherapy_induced_anemia: Initial 2.25 mcg/kg SC once weekly or 500 mcg SC once every 3 weeks. Discontinue when chemotherapy is completed or if Hb exceeds 10 g/dL.
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Pediatric Dosing

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

Renal Impairment:

Mild: No specific adjustment needed, dosing based on response to maintain target hemoglobin.
Moderate: No specific adjustment needed, dosing based on response to maintain target hemoglobin.
Severe: No specific adjustment needed, dosing based on response to maintain target hemoglobin.
Dialysis: Dosing for CKD patients on dialysis is specified in standard adult/pediatric dosing. No additional adjustment beyond standard CKD dosing.

Hepatic Impairment:

Mild: No specific adjustment needed.
Moderate: No specific adjustment needed.
Severe: No specific adjustment needed. 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 to stimulate red blood cell production and differentiation. Darbepoetin alfa has a longer half-life than epoetin alfa due to 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); approximately 49 hours (SC)
Clearance: Approximately 0.6 mL/hr/kg (IV)
ExcretionRoute: Renal and hepatic clearance
Unchanged: Minimal
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Pharmacodynamics

OnsetOfAction: Increase in reticulocytes typically seen within 7-10 days; increase in hemoglobin within 2-6 weeks.
PeakEffect: Peak hemoglobin response typically observed 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

Increased Mortality, Myocardial Infarction, Stroke, and Thromboembolism: ESAs increase the risk of death, myocardial infarction, stroke, venous thromboembolism, and thrombosis of vascular access. Use the lowest dose sufficient to avoid red blood cell transfusions. Cancer: ESAs shortened overall survival and/or increased the risk of tumor progression or recurrence in clinical studies of patients with breast, non-small cell lung, head and neck, lymphoid, and cervical cancers. For patients with cancer receiving myelosuppressive chemotherapy, use ESAs only when the anticipated benefit of reducing red blood cell transfusions outweighs the risk of serious adverse cardiovascular reactions and tumor progression or recurrence. ESAs are not indicated for patients with cancer receiving myelosuppressive chemotherapy when the anticipated outcome is cure. Discontinue Aranesp when the chemotherapy course is completed. Chronic Kidney Disease: In CKD patients, ESAs increased the risk of death, serious adverse cardiovascular reactions, and stroke. Target a hemoglobin level of 10 to 11 g/dL. Do not exceed a hemoglobin level of 11 g/dL. Pure Red Cell Aplasia (PRCA): Cases of PRCA and severe anemia, with associated antibodies to erythropoietin, have been reported in patients treated with ESAs. Discontinue Aranesp and do not switch to another ESA.
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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 Medical Help Right Away

If you experience any of the following symptoms, which may indicate a blood clot, contact your doctor immediately or seek emergency medical attention:

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, known as Stevens-Johnson syndrome or toxic epidermal necrolysis, which can lead to serious health problems and even death. If you notice any of the following symptoms, seek medical help 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 do not experience any side effects or only 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
  • Weakness or numbness 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)
  • Unusual tiredness or paleness (could indicate PRCA)
  • Signs of high blood pressure (e.g., severe headache, blurred vision, dizziness)
  • Signs of an allergic reaction (e.g., rash, itching, hives, swelling of face/lips/tongue, 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:

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 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 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.
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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 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 blood pressure checks are crucial while taking this medication, as it can cause high blood pressure. Follow your doctor's instructions for monitoring 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, plan 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.
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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:

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

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 erythropoietic response. Iron deficiency can lead to resistance to ESA therapy.

Timing: Prior to and during therapy.

Blood pressure (BP)

Rationale: ESAs can cause or exacerbate hypertension.

Timing: Prior to initiation of therapy.

Complete Blood Count (CBC) with differential and platelet count

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

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 (CKD); <10 g/dL (Chemotherapy-induced anemia, discontinue if >10 g/dL)

Action Threshold: Adjust dose if Hb increases by >1 g/dL in 2 weeks or exceeds target range. Withhold dose if Hb exceeds target.

Iron status (serum ferritin, TSAT)

Frequency: Monthly or quarterly, or as clinically indicated.

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

Action Threshold: Supplement iron if levels are low to ensure optimal response.

Blood pressure (BP)

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

Target: Individualized, typically <140/90 mmHg

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

Potassium

Frequency: Periodically, especially in CKD patients.

Target: 3.5-5.0 mEq/L

Action Threshold: Monitor for hyperkalemia, which can occur with rapid increase in red cell mass.

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Symptom Monitoring

  • Signs and symptoms of cardiovascular events (e.g., chest pain, shortness of breath, weakness, numbness, vision changes, slurred speech)
  • Signs and symptoms of tumor progression or recurrence (in cancer patients)
  • Signs and symptoms of hypertension (e.g., headache, dizziness, blurred vision)
  • Signs and symptoms of allergic reactions (e.g., rash, itching, hives, swelling, difficulty breathing)
  • Signs and symptoms of pure red cell aplasia (PRCA) (e.g., sudden worsening of anemia, fatigue, pallor)
  • Signs and symptoms of thrombotic events (e.g., pain, swelling, redness in a limb, sudden severe headache)

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 on the fetus.

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. 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.

Infant Risk: Not available; potential unknown risk.
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Pediatric Use

Approved for anemia associated with CKD in pediatric patients 1 month of age and older. 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. However, elderly patients may be more sensitive to the effects of ESAs, particularly regarding cardiovascular events. Dose selection should be cautious, generally starting at the low end of the dosing range.

Clinical Information

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Clinical Pearls

  • Darbepoetin alfa has a longer half-life than epoetin alfa, allowing for less frequent dosing (e.g., weekly, bi-weekly, or monthly).
  • Always ensure adequate iron stores (ferritin and TSAT) before and during darbepoetin alfa therapy, as iron deficiency is a common cause of ESA hyporesponsiveness.
  • Strictly adhere to the hemoglobin target range (10-11 g/dL for CKD) and avoid exceeding 11 g/dL due to increased risks of serious adverse events, including death and cardiovascular events.
  • Monitor blood pressure closely, as hypertension is a common side effect and may require aggressive management.
  • In cancer patients, ESAs are only indicated for chemotherapy-induced anemia when the anticipated outcome is not cure, and the benefit of avoiding transfusions outweighs the risks of tumor progression and serious cardiovascular events.
  • Patients should be educated on the signs and symptoms of serious adverse events, including blood clots, stroke, heart attack, and worsening hypertension, and instructed to seek immediate medical attention if these occur.
  • Pure Red Cell Aplasia (PRCA) is a rare but serious complication; if suspected, discontinue Aranesp and do not switch to another ESA.
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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
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Cost & Coverage

Average Cost: Varies widely by strength and quantity per single-use prefilled syringe
Insurance Coverage: Tier 3 or Specialty Tier (requires prior authorization, often subject to 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 for further guidance. 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 about its use. 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 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.