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

Aranesp® may cause serious side effects that can lead to death, including:

For people with cancer:

  • In patients with breast, non-small cell lung, head and neck, lymphoid, and cervical cancers: Your tumor may grow faster and you may die sooner if you choose to take Aranesp®.
  • Your healthcare provider will talk with you about these risks.

For all people who take Aranesp®, including people with cancer or chronic kidney disease:

  • Serious heart problems, such as heart attack or heart failure, and stroke. You may die sooner if you are treated with Aranesp® to increase red blood cells (RBCs) to near the same level found in healthy people.
  • Blood clots. Blood clots may happen at any time while taking Aranesp®. If you are receiving Aranesp® for any reason and are going to have surgery, talk with your healthcare provider about whether you need to take a blood thinner to lessen the chance of blood clots during or following surgery.
  • Call your healthcare provider or get medical help right away if you have any of these symptoms:

    • Chest pain
    • Trouble breathing or shortness of breath
    • Pain or swelling in your legs
    • A cool or pale arm or leg
    • Sudden confusion, trouble speaking, or trouble understanding others' speech
    • Sudden numbness or weakness in your face, arm, or leg, especially on one side of your body
    • Sudden trouble seeing
    • Sudden trouble walking, dizziness, loss of balance or coordination
    • Loss of consciousness (fainting)
    • Hemodialysis vascular access stops working

If you decide to take Aranesp®, your healthcare provider should prescribe the smallest dose that is necessary to reduce your chance of needing RBC transfusions.

If your hemoglobin level stays too high or goes up too quickly, this may lead to serious health problems which may result in death. These serious health problems may happen if you take Aranesp®, even if you do not have an increase in your hemoglobin level.

Do not take Aranesp® if you:

  • Have cancer and have not been counseled by your healthcare provider about treatment with Aranesp®.
  • Have high blood pressure that is not controlled (uncontrolled hypertension).
  • Have been told by your healthcare provider that you have, or have ever had a type of anemia called Pure Red Cell Aplasia (PRCA) that starts after treatment with Aranesp® or other erythropoietin medicines.
  • Have had a serious allergic reaction to Aranesp®.

Before taking Aranesp®, tell your doctor if you: have heart disease; have high blood pressure; have had a seizure or stroke; or if you are pregnant or breastfeeding, or plan to become pregnant or breastfeed.

If you know you are allergic to latex, talk to your healthcare provider before using Aranesp® because the needle cover on the prefilled syringe contains latex.

Aranesp® may cause other serious side effects, including:

  • High blood pressure. High blood pressure is a common side effect of Aranesp® in people with chronic kidney disease. Your blood pressure may go up or be difficult to control with blood pressure medication while taking Aranesp®. This can happen even if you have never had high blood pressure before. Your healthcare provider should check your blood pressure often.
  • Seizures. If you have seizures while taking Aranesp®, get medical help right away and tell your healthcare provider.
  • Antibodies to Aranesp®. Your body may make antibodies to Aranesp® that can block or lessen your body’s ability to make RBCs and cause you to have severe anemia. Call your healthcare provider if you have unusual tiredness, lack of energy, dizziness, or fainting. You may need to stop taking Aranesp®.
  • Serious allergic reactions. Serious allergic reactions can cause a skin rash, itching, shortness of breath, wheezing, dizziness and fainting due to a drop in blood pressure, swelling around your mouth or eyes, fast pulse, or sweating. If you have a serious allergic reaction, stop using Aranesp® and call your healthcare provider or get medical help right away.
  • Severe skin reactions. Signs and symptoms of severe skin reactions with Aranesp® may include: skin rash with itching, blisters, skin sores, peeling or areas of skin coming off. If you have any signs or symptoms of a severe skin reaction, stop using Aranesp® and call your healthcare provider or get medical help right away.

Common side effects of Aranesp® include:

  • Shortness of breath
  • Cough
  • Low blood pressure during dialysis
  • Abdominal pain
  • Edema (swelling) of the arms or legs

These are not all the possible side effects of Aranesp®. Tell your healthcare provider about any side effects that bother you or do not go away.

You are encouraged to report negative side effects of prescription drugs to the US Food and Drug Administration (FDA). Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

Indications

Aranesp® is a prescription medicine used to treat a lower than normal number of red blood cells (anemia) caused by chronic kidney disease in patients on dialysis and not on dialysis.

Aranesp® is a prescription medicine used to treat a lower than normal number of red blood cells (anemia) caused by chemotherapy that will be used for at least two months after starting Aranesp®.

Limitations of Use

Aranesp® has not been proven to improve quality of life, fatigue, or well-being.

Aranesp® should not be used for the treatment of anemia:

  • If you have cancer and you will not be receiving chemotherapy that may cause anemia for at least 2 more months
  • If you have a cancer that has a high chance of being cured
  • If your anemia caused by chemotherapy treatment can be managed by RBC transfusion.
  • In place of emergency treatment for anemia (red blood cell transfusions)

Please see Full Prescribing Information, including Boxed WARNINGS, and Medication Guide.

Important Safety Information

Aranesp® may cause serious side effects that can lead to death, including:
For people with cancer
  • In patients with breast, non-small cell lung, head and neck, lymphoid, and cervical cancers: Your tumor may grow faster and you may die sooner if you choose to take Aranesp®.
  • Your healthcare provider will talk with you about these risks.
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