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.

ARANESP® PROVIDES
CONVENIENT
DOSING OPTIONS

Designed for individualized treatment
  • Convenience of less frequent
    dosing with QW and Q2W intervals
    vs TIW dosing1
  • Multiple dosing options can be
    combined to individualize
    treatment of patients1
dosing options

 

Aranesp® is also available in 150, 200, 300, and 500 mcg dose strengths. Aranesp® is available in single-dose vials and prefilled syringes, except the 10, 150, and 500 mcg dose strengths, which are available only as prefilled syringes.

 

The IV route of administration is recommended for adult patients on hemodialysis.

DOSE COMBINATIONS

Aranesp® single-dose strengths can be combined to
more
precisely titrate doses and individualize anemia
management
for patients with CKD on dialysis.1,*

Precision dosing with the 10 mcg dose
dose strength dose strength

With the 10 mcg dose strength, doses can be precisely
titrated within 5 mcg intervals.1,*

*Except 15 mcg dose.

pdf Image

DOWNLOAD
Multiple Dosing Options Brochure

DOWNLOAD Prescribing Information

 
 

Take a glance at the following doses to see which
single-dose strengths may be combined to individualize anemia management.

dose-strength-mcg-table dose-strength-mcg-table
Pinch to zoom.

ARANESP® SINGLEJECT® PREFILLED SYRINGES

 
  • Prefilled syringes may reduce potential for dosing errors2
  • UltraSafe® Needle Guard is designed to protect from unintentional needlesticks3
  • Bar-coded label identifies drug and dose
  • No additional wholesale acquisition costs compared to vials4

Dosing information:
Aranesp® (darbepoetin
alfa) for anemia due
to CKD

  • In controlled trials, patients experienced
    greater risks for death, serious adverse
    cardiovascular reactions, and stroke when
    administered ESAs to target a Hb level of
    greater than 11 g/dL.
  • No trial has identified a Hb target level,
    Aranesp® dose, or dosing strategy that does
    not increase these risks.
  • Individualize dosing and use the lowest dose of Aranesp® sufficient to reduce the need for RBC transfusions.
  • Physicians and patients should weigh the possible benefits of decreasing transfusions against the increased risks of death and other serious cardiovascular adverse events.
Considerations
  • Correct or exclude other causes of anemia
    before initiating Aranesp®.
  • Evaluate the iron status in all patients before
    and during treatment.
  • Administer supplemental iron therapy if serum ferritin is < 100 mcg/L or serum transferrin saturation is < 20%. The majority of patients with CKD will require supplemental iron during the course of ESA therapy.
  • Appropriately control hypertension prior to
    initiation of and during treatment with Aranesp®.
    • Reduce or withhold Aranesp® if blood
      pressure becomes difficult to control.
INITIATING ARANESP® FOR ADULT
PATIENTS WITH CKD ON DIALYSIS
  • Initiate Aranesp®  treatment when the Hb level is
    < 10 g/dL.
  • QW recommended starting dose:
    0.45 mcg/kg as an IV or SC injection
    once weekly, as appropriate.
  • Q2W recommended starting dose:
    0.75 mcg/kg as an IV or SC injection
    once every 2 weeks, as appropriate.
    • The IV route of administration is recommended for patients on hemodialysis.
 
 
INITIATING ARANESP® FOR ADULT
PATIENTS WITH CKD NOT ON DIALYSIS
  • Consider initiating Aranesp® treatment only when the Hb level is < 10 g/dL
    and the following
    considerations apply:
    • The rate of Hb decline indicates the likelihood of
      requiring a RBC transfusion, and
    • Reducing the risk of alloimmunization and/or
      other RBC
      transfusion-related risks is a goal
  • Q4W recommended starting dose: 0.45 mcg/kg
    body weight as an IV or SC
    injection once at 4 week intervals as appropriate.
Initiating Aranesp® for pediatric patients (less than 18 years) with CKD
  • Initiate Aranesp® treatment when the Hb
    level is < 10 g/dL.
On dialysis and not on dialysis:
  • QW recommended starting dose: 0.45 mcg/kg as an IV or SC injection once weekly, as appropriate.
Not on dialysis:
  • Q2W recommended starting dose: 0.75 mcg/kg as an IV or SC injection once every 2 weeks, as appropriate.
MONITORING

Following initiation of therapy and after each
dose
adjustment, monitor Hb at least weekly
until the Hb
is stable and sufficient to minimize
the need for
RBC transfusion.

  • Thereafter, Hb should be monitored at least

    monthly, provided that Hb levels remain stable.
 
 
DOSE ADJUSTMENTS

When adjusting therapy, consider Hb rise, rate of decline,
ESA
responsiveness, and Hb variability.

  • A single Hb excursion may not require a
    dosing change.
  • Do not increase the dose more frequently than
    once
    every 4 weeks.
  • Decreases in dose can occur more frequently.
  • Avoid frequent dose adjustments.
REDUCE OR INTERRUPT DOSE
  • If Hb rises rapidly (eg, more than 1 g/dL in any
    2-week period), reduce the dose by 25% or
    more, as needed, to reduce rapid responses.
FOR ADULT PATIENTS WITH CKD
  • On dialysis: reduce or interrupt dose if the Hb
    level approaches or exceeds 11 g/dL.
  • Not on dialysis: if the Hb level exceeds 10
    g/dL, reduce or interrupt the dose of Aranesp®,
    and use the lowest dose of Aranesp®
    sufficient to reduce the need for RBC
    transfusions.
FOR PEDIATRIC PATIENTS (LESS THAN 18
YEARS) WITH CKD
  • If the hemoglobin level approaches or exceeds
    12 g/dL, reduce or interrupt the dose of
    Aranesp®.
INCREASE DOSE
  • If the Hb has not increased by more than 1 g/dL
    after 4 weeks of therapy, increase the dose by
    25% when appropriate.
Patients who do not respond adequately to Aranesp®
  • 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.
  • Evaluate other causes of anemia.
  • If typical causes of lack or loss of Hb response
    are excluded, evaluate for pure red cell aplasia (PRCA).
  • Discontinue Aranesp® if responsiveness does
    not improve.

Patients with CKD and an insufficient Hb
response to ESA therapy or a rate of Hb rise
of > 1 g/dL over 2 weeks may be at an even
greater risk for cardiovascular reactions
and mortality than other patients.

CONVERSION TO ARANESP®

Converting patients on dialysis from epoetin alfa to QW Aranesp®1
previous-epoeti-alfa-unit-table
Pinch to zoom.

The dose conversions depicted above do not accurately estimate the once-monthly dose of Aranesp® in patients with CKD not on dialysis.

For pediatric patients receiving a weekly epoetin alfa dose of < 1,500 units/week. The available data are insufficient to determine an Aranesp® conversion dose.

Remember to convert your patient's previous epoetin alfa per-administration dose to a per-week measurement. Here's an example how1:

epoetin-alpha-dose-per-week-table
Pinch to zoom.
doctorsroomdoc-office-image

Aranesp® is administered less frequently than epoetin alfa1

  • Administer Aranesp® once weekly in patients who were receiving epoetin alfa 2 to 3 times weekly
  • Administer Aranesp® once every 2 weeks in patients who were receiving epoetin alfa once weekly
  • Maintain the route of administration (intravenous or subcutaneous injection)
  • The dose conversion in the chart above does not accurately estimate the once-monthly dose of Aranesp®

USE THE FDA-APPROVED ESA CONVERSION TABLE IN THE ARANESP® PI TO CONVERT PATIENTS ON DIALYSIS FROM EPOETIN ALFA TO ARANESP®1
  • Pediatric patients with CKD: Aranesp® safety and efficacy were similar between adults and pediatric patients with CKD when Aranesp® was used for initial treatment of anemia or patients were transitioned from treatment with epoetin alfa to Aranesp®
 
 
THERE IS NO SINGLE DCR WHEN CONVERTING FROM EPOETIN ALFA TO ARANESP®1
  • Depending on the dose of epoetin alfa at the time of substitution, the Aranesp®:epoetin alfa DCR may range from 200:1 to 900:1
pl-based-epoetin-alpha pl-based-epoetin-alpha
Pinch to zoom.
Hb = hemoglobin; QW = once weekly; Q2W = once every 2 weeks; TIW = 3 times weekly; IV = intravenous; CKD = chronic kidney disease; DCR = dose conversion ratio; ESA = erythropoiesis-stimulating agent; RBC = red blood cell count; Q4W = once every 4 weeks; SC = subcutaneous.

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.
TOP