Indication

Aranesp® (darbepoetin alfa) is indicated for the treatment of anemia due to chronic kidney disease (CKD), including patients on dialysis and patients not on dialysis.READ MORE

Limitations of Use
  • Aranesp® has not been shown to improve quality of life, fatigue, or patient well-being.
  • Aranesp® is not indicated for use as a substitute for red blood cell transfusions in patients who require immediate correction of anemia.

DIALYSIS PATIENTS’ Hb

LEVELS CAN BE UNSTABLE

Significant Hb changes
can happen over time

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97%

of patients had a mean monthly Hb change that caused them to move out of the ≥ 10 to ≤ 11 g/dL range from baseline by month 81,*

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69%

of patients experienced an  unpredictable clinical event2.†

*These patients had a mean baseline Hb ≥ 10 to ≤ 11 g/dL when monitoring began. 

Data are from OutcomesPlus, a national database of clinical data from patients receiving dialysis in facilities across the United States, excluding hospital and governmental entity patients. It contains information from the majority of the US dialysis population. The analyses consisted of calculating the monthly Hb levels, monthly Hb categories, and the change in Hb categories for individual patients from April 2013 to December 2013 (N = 1674). Patients were included if both intravenous ESA dose and Hb data were available for every month of the time period. Each patient's initial Hb category, during the baseline month, was used as the reference over time. Patients were categorized within a "moved to" group once they moved out of their baseline month category, and they were counted within a "remained" category if they maintained the same Hb category as the baseline month (until the month of the first change). 

Based on a 6-month, retrospective analysis of all Medicare primary payer hemodialysis patients who survived and had ESA claims in the first 6 months of 2004 (N = 159,720). Unpredictable clinical events patients experienced during the 6-month study included hospitalization, vascular access insertions/complications, or receipt of IV antibiotics (ie, more serious infections). 

UNPREDICTABLE CLINICAL EVENTS CAN INCLUDE:

 
  • Hospitalization3-6
  • Infection3,6
  • Inflammation5,6
  • Number/Severity of comorbidities3,5
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ARANESP® ENABLES

TIMELY INTERVENTION

Address Hb excursions by intervening
with Aranesp®

Aranesp® dosing intervals provide an ability to intervene, helping to:

 

  • Maintain Hb levels above 10 g/dL7
  • Reduce transfusion risk8
  • Individualize treatment7

 

tilde82%

of Hb monitoring practices occur within 2 weeks, which is similar to Aranesp® dosing intervals7,9,‡

 

Data are from OutcomesPlus, a national database of clinical data from patients receiving dialysis in facilities across the United States, excluding hospital and governmental entity patients. It contains information from the majority of the US dialysis population. The analysis consisted of calculating an average quarterly frequency of Hb monitoring from Q1 2014 to Q2 2017 from MDOs.

 

MDO = medium dialysis organization. 

Hb INSTABILITY

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1

TREND

Monitor Hb regularly§ and note the trend of a patient’s Hb values over time to more accurately assess Hb status7

§At least weekly until stable and then at least monthly.

 
 
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2

PREDICT

Once the patient’s data have been trended, the future Hb response may be predicted by evaluating the rate at which Hb is decreasing or increasing7

 
 
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3

INTERVENE

Based on the prediction, clinicians can intervene to address underlying conditions that may affect the patient’s Hb level and determine whether an adjustment of the Aranesp® dose is needed7

WATCH a hypothetical patient case study on the experience of a patient with anemia due to CKD. Stream video now at anemiahub.com

§At least weekly until stable and then at least monthly.

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ARANESP® PROVIDES THE ABILITY TO INTERVENE WHEN
PATIENTS EXPERIENCE FREQUENT CHANGES TO THEIR Hb LEVELS7,10

ARANESP® AND HOW
TO INTERVENE

In adult patients with CKD on dialysis
Address Hb excursions by intervening with Aranesp®7
  • Initiate Aranesp® treatment when Hb is < 10 g/dL
  • The Hb response time to Aranesp® can be 2-6 weeks
  • A single Hb excursion may not require a dosing change
Intervene to address Hb increase7
  • Reduce or interrupt dose if the Hb level approaches or exceeds 11 g/dL in adult patients with CKD on dialysis
  • Decreases in dose can occur as clinically appropriate
  • Avoid frequent dose adjustments
Adress-HB-Increase
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Intervene to address Hb decrease7
  • Do not increase the dose more frequently than once every 4 weeks
Adress-HB-Decrease
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Important Dosing Considerations
  • For patients who do not respond adequately over a 12-week escalation period, increasing the Aranesp® dose further is unlikely to improve response and may increase risks.
  • Use the lowest dose that will maintain a Hb level sufficient to reduce the need for RBC transfusions.

**Please see Aranesp® Dosing Information.

THE EXTENDED ACTIVITY
OF ARANESP®

Aranesp® has 5 sialic acid–containing N-linked carbohydrate chains.11,12
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The molecular structure of  Aranesp® provides extended erythropoietic activity11,12

Aranesp® has the
same MOA as
natural
erythropoietin

Aranesp® stimulates erythropoiesis and iron supports proper heme formation.13-17
  • The Hb response time to Aranesp® can be 2-6 weeks7
MOA
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MOA = mechanism of action.

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Due to the extended erythropoietic activity of Aranesp®,
it can be dosed once weekly or once every 2 weeks7,11,12

Hb = hemoglobin; ESA = erythropoiesis-stimulating agent; MDO = medium dialysis organization; CKD = chronic kidney disease.

Important Safety Information including Boxed WARNINGS

WARNING: ESAs INCREASE THE RISK OF DEATH, MYOCARDIAL INFARCTION, STROKE, VENOUS THROMBOEMBOLISM, THROMBOSIS OF VASCULAR ACCESS AND TUMOR PROGRESSION OR RECURRENCE
Chronic Kidney Disease:
  • In controlled trials, patients experienced greater risks for death, serious adverse cardiovascular reactions, and stroke when administered erythropoiesis-stimulating agents (ESAs) to target a hemoglobin level of greater than 11 g/dL.
  • No trial has identified a hemoglobin target level, Aranesp® dose, or dosing strategy that does not increase these risks.
  • Use the lowest Aranesp® dose sufficient to reduce the need for red blood cell (RBC) 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.
  • To decrease these risks, as well as the risk of serious cardiovascular and thromboembolic reactions, use the lowest dose needed to avoid RBC transfusions.
  • Use ESAs only for anemia from myelosuppressive chemotherapy.
  • ESAs are not indicated for patients receiving myelosuppressive chemotherapy when the anticipated outcome is cure.
  • Discontinue following the completion of a chemotherapy course.
  • Aranesp® is contraindicated in patients with:
  • Uncontrolled hypertension
  • Pure red cell aplasia (PRCA) that begins after treatment with Aranesp® or other erythropoietin protein drugs
  • Serious allergic reactions to Aranesp®
  • Use caution in patients with coexistent cardiovascular disease and stroke.
  • Patients with CKD and an insufficient hemoglobin response to ESA therapy may be at even greater risk for cardiovascular reactions and mortality than other patients. A rate of hemoglobin rise of > 1 g/dL over 2 weeks may contribute to these risks.
  • In controlled clinical trials, ESAs increased the risk of death in patients undergoing coronary artery bypass graft surgery (CABG) and the risk of deep venous thrombosis (DVT) in patients undergoing orthopedic procedures.
  • Control hypertension prior to initiating and during treatment with Aranesp®.
  • Aranesp® increases the risk of seizures in patients with CKD. Monitor patients closely for new-onset seizures, premonitory symptoms, or change in seizure frequency.
  • For lack or loss of hemoglobin response to Aranesp®, initiate a search for causative factors. If typical causes of lack or loss of hemoglobin response are excluded, evaluate for PRCA.
  • Cases of PRCA and of severe anemia, with or without other cytopenias that arise following the development of neutralizing antibodies to erythropoietin have been reported in patients treated with Aranesp®.
  • This has been reported predominantly in patients with CKD receiving ESAs by subcutaneous administration.
  • PRCA has also been reported in patients receiving ESAs for anemia related to hepatitis C treatment (an indication for which Aranesp® is not approved).
  • If severe anemia and low reticulocyte count develop during treatment with Aranesp®, withhold Aranesp® and evaluate patients for neutralizing antibodies to erythropoietin.
  • Permanently discontinue Aranesp® in patients who develop PRCA following treatment with Aranesp® or other erythropoietin protein drugs. Do not switch patients to other ESAs.
  • Serious allergic reactions, including anaphylactic reactions, angioedema, bronchospasm, skin rash, and urticaria may occur with Aranesp®. Immediately and permanently discontinue Aranesp® if a serious allergic reaction occurs.
  • Blistering and skin exfoliation reactions including Erythema multiforme and Stevens-Johnson Syndrome (SJS)/Toxic Epidermal Necrolysis (TEN), have been reported in patients treated with ESAs (including Aranesp®) in the postmarketing setting. Discontinue Aranesp® therapy immediately if a severe cutaneous reaction, such as SJS/TEN, is suspected.
  • Adverse reactions (≥ 10%) in Aranesp® clinical studies in patients with CKD were hypertension, dyspnea, peripheral edema, cough, and procedural hypotension.

Indication

Aranesp® (darbepoetin alfa) is indicated for the treatment of anemia due to chronic kidney disease (CKD), including patients on dialysis and patients not on dialysis.

Limitations of Use

  • Aranesp® has not been shown to improve quality of life, fatigue, or patient well-being.
  • Aranesp® is not indicated for use as a substitute for red blood cell transfusions in patients who require immediate correction of anemia.

REFERENCES

1. Aranesp® (darbepoetin alfa) prescribing information, Amgen. 2. Adapa RM, Mani V, Murray LJ, et al. Errors during the preparation of drug infusions: a randomized controlled trial. Br J Anaesth. 2012;109(5):729-734. 3. UltraSafe® Needle Guards [brochure]. Carlsbad, CA: Safety Syringes, Inc.; 2007. 4. Data on file, Amgen; [WAC Pricing; 2012].
 

Important Safety Information including Boxed WARNINGS

WARNING: ESAs INCREASE THE RISK OF DEATH, MYOCARDIAL INFARCTION, STROKE, VENOUS THROMBOEMBOLISM, THROMBOSIS OF VASCULAR ACCESS AND TUMOR PROGRESSION OR RECURRENCE
Chronic Kidney Disease:
  • In controlled trials, patients experienced greater risks for death, serious adverse cardiovascular reactions, and stroke when administered erythropoiesis-stimulating agents (ESAs) to target a hemoglobin level of greater than 11 g/dL.
  • No trial has identified a hemoglobin target level, Aranesp® dose, or dosing strategy that does not increase these risks.
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